[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Neurological Disorders and Stroke (NINDS)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":594},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,51,0,25,[9,48,73,100,125,156,178,204,229,250,271,293,311,336,357,375,399,423,446,468,490,511,531,552,571],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100622817","phase-i-open-label-safety-trial-of-pembrolizumab-for-neurological-post--acute-sequelae-of-sars-cov-2-pd1-pasc-i-100622817",false,"NCT07388550","Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)","Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post-Acute Sequelae of SARS-CoV-2 (PD1-PASC I)","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male or female, aged at least 18 or older.\n\n  --Documentation of the SARS-CoV-2 infection that led to development of PASC confirmed either by a positive testing by a commercial laboratory or a positive home test followed by confirmatory nucleocapsid antibody testing.\n* Previously diagnosed with mild-moderate COVID-19 (WHO Clinical Progression Scale between 2-5. Participants who had severe acute COVID-19 requiring hospitalization or ICU care are excluded.\n* If participants had multiple SARS-CoV-2 infections, they would need to be at least 6 months after the last infection.\n* All participants would need to have a negative SARS-CoV-2 nasal swab at the time of enrollment.\n* Exhibiting persistent neurologic symptoms evidenced by a self-reported illness narrative of the development of persistent PASC symptoms after recovering from a SARS-CoV-2 infection. These include symptoms such as fatigue, cognitive difficulties, sleep disturbances, orthostatic intolerance, and any ongoing issues with gait instability, vision, speech, swallowing, sensation, or strength. Symptoms must persist for at least 6 months after the diagnosis of acute COVID-19.\n* All participants will have PD-1 expression on CD8 T cells that is one SD above the mean value of normal controls as established in the SINS Lab and published previously.\n* Moderate to severe PASC symptom severity, as determined using PCFS (minimal score of 3).\n* Ability of participant to understand and sign a written informed consent document.\n* Prior completion of a clinical brain MRI after the diagnosis of COVID-19, or willingness to complete a brain MRI.\n* Agrees not to have vaccinations over the course of the study.\n* Participants of childbearing potential must agree to use a combination of contraception (defined as two forms of effective birth control) or have had surgical sterilization, from the time of enrollment until 4 months after the dose of study drug.\n* Participants capable of sperm donation must agree to not donate sperm from the time of enrollment until 4 months after the dose of study drug.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* For participants who have not completed a brain MRI since onset of symptoms: inability to complete brain MRI with gadolinium including contraindicated metal in the body, prior allergic reaction to gadolinium, eGFR \\\u003C45 mmol\u002FL, or claustrophobia that is unable to be adequately treated with a low dose oral benzodiazepine.\n* Contraindication to a research lumbar puncture, including use of anticoagulant medication, platelets \\\u003C 50,000\u002FuL, PT or PTT \\>1.5 x ULN for the NIH Clinical Center, if risk of lumbar puncture is increased for other reasons such as space occupying lesion, skin infection at site of the puncture or otherwise inability to complete the procedure.\n* A condition that would significantly confound interpretation of the clinical and research tests as determined by the study investigators. This could include traumatic brain injury, substance use disorder, active malignancy, systemic immunologic disorders, current or previous long-term immune suppressive therapy.\n* Any premorbid medical condition that would potentially cause fatigue and exercise intolerance. This includes many chronic medical diseases, such as congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe arthritis, uncontrolled asthma, renal failure, fibromyalgia, and ME\u002FCFS.\n* Symptom severity that makes it impossible for the participant to travel to NIH.\n* Received a SARS-CoV-2 vaccine dose within less than 4 weeks of enrollment or is planning for any additional vaccines during the study.\n* Prior treatment for PASC with immunomodulatory therapies such as check point inhibitors which in the opinion of the investigators could impact the outcome of this study.\n* Current medications include oral steroids or other immunosuppressive medications which in the opinion of the investigators could impact the outcome of this study.\n* Active participation in a clinical protocol which includes any intervention that may affect the results of the current study.\n* Abnormal anti-thyroid panel (anti-TPO and anti-TG) test at screening visit.\n* ANA titer of 1:80 or greater, positive anti-CCP.\n* Abnormal screening blood tests exceeding any of the limits defined below or as deemed exclusionary by the investigators on review at baseline:\n\n  * Aspartate aminotransferase and alanine aminotransferase values \\>2x upper limit of normal precluding the use of acetaminophen\n  * Fasting triglyceride \\> 300 mg\u002FdL.\n  * Total bilirubin \\>2x upper limit of normal (unless participant has Gilbert syndrome)\n  * Creatinine Clearance or eGFR \\\u003C60 ml\u002Fminute (adjusted for race)\n  * Hemoglobin \\\u003C 10 g\u002FdL\n  * Absolute neutrophil count \\\u003C 1000\u002Fmicroliter\n  * Platelet count \\\u003C130,000\u002Fmm3 (if platelet clumping is present on hematology slide review, platelet count \\\u003C100,000\u002Fmm3 is considered exclusionary to study)\n  * Hemoglobin A1c \\>= 6%\n  * Thyroid-stimulating hormone (TSH) and adrenocorticotropic hormone (ACTH) within normal limits. If TSH is not within normal limits then the participant may be eligible if thyroxine (T4) is within normal limits. Participants are not excluded if they are on a stable dose of replacement thyroid medication; dose may be adjusted as needed.\n* Previously documented anaphylaxis or severe systemic reaction to check point inhibitors, acetaminophen, or diphenhydramine.\n* A severe psychiatric condition, which based on the assessment of the study investigators, will impact the ability to complete the study.\n* Pregnancy or planning to get pregnant.\n* Currently lactating\u002Fbreastfeeding.\n* Current or previous malignancy. A history of malignancy that has fully resolved with surgical resection only (e.g. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.\n* Current or past substance use disorder within last five years. Marijuana use within the past five years will not be an exclusion.\n* Infection with HIV, tuberculosis, hepatitis B or C.","ALL","18 Years","110 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Background:\n\nSARS-CoV-2 is the virus that causes COVID-19. Some people who recover from an acute COVID-19 infection may continue to have symptoms that persist for months or years. These can include neurological symptoms, such as headaches, loss of taste or smell, dizziness, or trouble walking. Pembrolizumab is a drug approved to treat certain cancers. Researchers think this drug might reduce long-term neurologic symptoms after a COVID-19 infection.\n\nObjective:\n\nTo test pembrolizumab in people with ongoing neurologic symptoms of COVID-19.\n\nEligibility:\n\nPeople aged 18 years or older who had COVID-19 at least 6 months ago and have ongoing neurologic symptoms.\n\nDesign:\n\nParticipants will have 7 clinic visits in 7 months.\n\nParticipants will be screened. They will have a physical exam with blood tests. Swabs will be used to collect cells from inside the mouth and nose. They may opt to have an imaging scan.\n\nParticipants will also have other tests before they are given the study drug. These include eye and skin exams; tests of their memory and thinking; and tests of involuntary body functions, such as heart rate, blood pressure, sweating, and digestion. Their grip strength and walking pace will be measured. They will wear a heart rate monitor for 24 hours. They will wear devices on a wrist and thigh to measure activity for 10 days.\n\nParticipants will have a lumbar puncture (spinal tap): A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.\n\nPembrolizumab is given through a needle inserted into a vein. Participants will receive 1 dose of the drug.\n\nParticipants will have 4 follow-up visits over 6 months. Tests may be repeated during these visits.",[28],"Post-Acute COVID-19 Syndrome",[30,31,32,33,34],"PASC","Long Covid","COVID","COVID-19","Postacute Sequelae of COVID","NOT_YET_RECRUITING","2026-08-20",{"date":38,"type":39},"2026-08-21","ACTUAL",{"date":41,"type":22},"2026-08-26",{"date":43,"type":22},"2028-01-01",{"name":45,"class":46},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100603509","distinguishing-tics-and-functional-tics-using-clinical-neurophysiological-techniques-100603509","NCT07137442","Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Capacity to provide informed consent (self-consent)\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 18-80\n* Agreement to adhere to Lifestyle Considerations prior to and during the physiological testing visit.\n\nInclusion criteria for patients with functional tics or tics\n\n\\- Diagnosed with functional motor tics or motor tics\n\nInclusion criteria for healthy controls\n\n\\- Have no neurological or psychiatric disorders established by history and physical\u002Fneurological examination\n\nEXCLUSION CRITERIA:\n\n* Self-reported consumption of \\>14 alcoholic drinks\u002Fweek\\* for a man and \\>7 alcoholic drinks\u002Fweek for a woman\n* Use of prescription drugs and other illicit drugs that may suppress tics such as dopamine blocking agents and antipsychotics during a certain time period prior to the\n\nneurophysiological testing session.\\*\\*\n\n* Clinically significant abnormal movements on neurological examination except for tics.\n* Contraindications to EEG or EMG procedures, including skin lesions at electrode sites or hypersensitivity to electrode materials.\n* History of or current brain tumor, stroke, head trauma with loss of consciousness.\n* Epilepsy or seizures in the past 12 months.\n* Have a Baclofen pump, or have neurostimulators for pain.\n* Pregnant women\n* Self-reported current major depression or Beck Depression Inventory II (BDI-II) score \\>19, Generalized Anxiety Disorder 7-item scale (GAD-7) score \\> 9, or any major current psychiatric illness.\n* Presence of any metal in the eye or skull area such as a brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye.\n* Presence of pacemaker, intracardiac lines, implanted pumps or stimulators.\n* Unable to comply with the requirements of the study procedures.\n* Vocal tics only tested with Modified Rush Video-Based Tic Rating Scale.\n* Low Premonitory Urge for Tics Scale (PUTS) score \\\u003C 9 (maximum 36) with low willingness for tics (patient groups only, not applicable in healthy volunteers).\n\n  * Note: 1 standard alcoholic drink is 0.6 ounce (14 grams) of pure alcohol.\n\n    * Note: The certain time period depends on different drugs used. Five half-lives will be selected. The drug is considered effectively eliminated from the body after this time period because the concentration of the drug reaches around 3% of the orininal concentration.","80 Years",{"count":56,"type":22},75,"OBSERVATIONAL","Background:\n\nTics are involuntary movements and vocalizations. Some tics are organic: They are related to diagnosed disorders. Sometimes tics have other causes, such as problems with how the brain and body send and receive messages. These are called functional tics. It can be difficult to tell the difference between these 2 types of tics. Doctors need to know more so they can make more accurate diagnoses.\n\nObjective:\n\nTo learn more about the difference between functional and organic tics.\n\nEligibility:\n\nAdults aged 18 to 80 years who have a tic that causes involuntary movements. Healthy volunteers with no tics are also needed.\n\nDesign:\n\nParticipants will have one 4-hour clinic visit. The visit may be done in 1 or 2 days. Participants will refrain from consuming alcohol or caffeine before the visit. They may have a physical exam.\n\nParticipants will wear two types of sensors:\n\nElectromyography (EMG): Adhesive disks with sensors will be attached to the skin above some muscles. These disks will record electricity in the muscles as the participant moves.\n\nElectroencephalography (EEG): Sensors will be placed on the participant s scalp. The sensors may be adhered directly, or the participant may wear an electrode cap. The sensors will detect brain waves.\n\nParticipants will rest while seated in a chair. Their involuntary tics will be monitored with the EMG and EEG. Then they will be asked to make movements to mimic their tics. Healthy volunteers will also rest; then they will be asked to perform movements that mimic tics.\n\nParticipants will have their blink reflex tested. EMG sensors will be placed on the muscles near the eyes. Electrical pulses will be used to stimulate blinking.\n\nParticipants will answer questionnaires about their tics and their health....",[60,61],"Tics","Functional Tics",[60,63,64,65,66],"Functional tics","EEG","Blink Reflex","Pre-pulse inhibition","RECRUITING",{"date":38,"type":39},{"date":41,"type":22},{"date":71,"type":22},"2034-08-01",{"name":45,"class":46},{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":97,"leadSponsor":99,"locationsCount":47},"100563423","screening-for-social-determinants-of-health-sdoh-and-cognitive-function-in-individuals-with-history-of-stroke-100563423","NCT06615973","Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke","Understanding Stroke Outcomes: Stroke Resilience, Infarct Burden, and Long-Term Cognition","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Adults aged 18 or older.\n* Previous participant in the Natural History of Stroke with an interpretable baseline MRI scan, NIHSS measured at baseline or discharge, and admission diagnosis of ischemic stroke.\n* Fluent in English or Spanish\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n-Modified Rankin Scale (mRS) = 6 at any follow-up (usually up to 90 days) in the Natural History of Stroke study (mRS = 6 indicates the participant is dead).","99 Years",{"count":82,"type":22},450,"Background:\n\nStroke is the fifth leading cause of death in the United States. It is also a leading cause of disability. More than 70% of people who survive strokes have mental impairment or dementia. Medical factors, such as the severity of the stroke, affect whether a person will have mental impairment afterward. But social factors, such as education and ethnicity, seem to play a role as well. Researchers want to learn more about how social and lifestyle factors affect a person s chances of maintaining mental functions after a stroke.\n\nObjective:\n\nTo better understand how social and lifestyle factors affect the risk of mental impairment after a stroke.\n\nEligibility:\n\nPeople aged 18 years and older who had a stroke and a brain scan while they were enrolled in NIH Study 01N0007 (Natural History of Stroke Study).\n\nDesign:\n\nParticipants will have 1 study visit, by telephone. The call will last about 45 minutes. Participants will talk about their health since their stroke. They will answer questions about themselves. Topics will include:\n\n* Their race\n* Education\n* Ethnicity\n* Employment\n* Marital status\n* Residence address\n* Recent health history\n* Medical insurance\n\nThey will have tests of their memory, attention, and language skills. They will repeat numbers and words forward and backward.\n\nResearchers will look at the data and imaging scans collected during participant s enrollment in NIH Study 01N0007. This data will include:\n\n* The hospital that first saw the participant at the time of their stroke.\n* The type of imaging that was first used then.\n* The primary diagnosis at admission.\n* Other medical details.",[85,86,87,88],"Stroke","Brain Disease","Vascular Diseases","Cerebrovascular Disorder",[85,90,91,92,93,94],"Social Determinants of Health","Cognition","cerebrovascular health","Magnetic Resonance Imaging (MRI)","vascular health",{"date":38,"type":39},{"date":41,"type":22},{"date":98,"type":22},"2027-02-01",{"name":45,"class":46},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"100218336","deep-brain-stimulation-therapy-in-movement-disorders-100218336","NCT02119611","Deep Brain Stimulation Therapy in Movement Disorders","* INCLUSION CRITERIA:\n\nTo be eligible for entry into the study, candidates must meet all the following criteria:\n\n* Be 18 years of age or older.\n* Able to comply with study procedures and provide informed consent.\n* Have a clinical diagnosis of idiopathic PD, primary dystonia, or ET:\n\n  1. The diagnosis of idiopathic PD will be based on the UK Brain Bank Criteria, and confirmed by the Movement Disorders Neurologists in the NIH Parkinson Clinic.\n  2. The diagnosis of primary (generalized or segmental), hemidystonia, or cervical dystonia will be confirmed on clinical examination in the NIH Movement Disorders Clinic.\n  3. The diagnosis of ET will be confirmed on clinical examination in the NIH Movement Disorders Clinic (the diagnosis of ET will be based on bilateral, largely symmetric postural or kinetic tremor involving hands and forearms that is visible and persistent. Additional or isolated tremor in head may be present but there should be the absence of abnormal posturing).\n* a. History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients. OR\n\n  b.Patients with tremor-dominant PD that do not respond to dopaminergic therapy and that exhibit a tremor score of at least 2 for tremor severity on at least one side of the body on the motor UPDRS examination.\n* Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of drugs), including:\n\nFor PD patients:\n\n1. good benefit from dopaminergic medication but associated with insufficient duration of action or unacceptable side-effects OR\n2. intractable disabling motor fluctuations (severe off periods, dyskinesias, or freezing spells) OR\n\n   For ET and dystonia:\n3. intractable symptoms of ET or dystonia impacting at least 2 activities of daily living.\n\n   * Interested in being evaluated to undergo DBS, if indicated, to treat medically refractory movement disorder or\n   * Patients already implanted with DBS for continued management\n\n(Note: Inclusion criteria 4 and 5 can be met by historical report in patients who had DBS implanted outside the NIH)\n\nEXCLUSION CRITERIA:\n\nFor those who have not had DBS:\n\nCandidates will be excluded if they meet any of the following criteria:\n\n* Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications, including but not limited to uncontrolled systemic hypertension with values above 170\u002F100; unstable heart disease; unstable respiratory disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted;\n* Evidence of secondary or atypical parkinsonism\u002Fdystonia\u002Ftremor as suggested by:\n\n  1. History of stroke, exposure to toxins, neuroleptics, or encephalitis\n  2. Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy, or multiple systems atrophy.\n  3. MR-imaging with evidence indicative of secondary disease such as tumor, or stroke, which could cause the movement disorder.\n* Dementia as evidenced by formal neuropsychological evaluation, Mattis Dementia Rating Scale (DRS-2) score, and clinical evaluations.\n* Unable to complete cognitive assessments and testing necessary to adequately evaluate risks and benefits of surgery.\n* Clinically signficiant or unstable psychiatric disorder such as severe depression or anxiety, which, in the opinion of the investigators would increase the risk of developing postoperative complications.\n* Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small closed spaces (have claustrophobia), or cannot lie comfortably on their back for up to one hour.\n* Pregnant women.\n* Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia\n\nFor those who have had DBS:\n\n-Contra-indications for ongoing stimulation, such as intractable side effects of DBS despite stimulation parameter adjustment","100 Years",{"count":108,"type":22},300,[110],"NA","Background:\n\n\\- In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest. It is attached to wires in parts of the brain that affect movement. DBS might help people with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET).\n\nObjective:\n\n\\- To provide DBS treatment to people with some movement disorders.\n\nEligibility:\n\n\\- Adults 18 years and older with PD, ET, or certain forms of dystonia.\n\nDesign:\n\n* Participants will be screened with medical history and physical exam. They will have blood and urine tests and:\n* MRI brain scan. The participant will lie on a table that slides in and out of a metal cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will get earplugs for the loud noises. During part of the MRI, a needle will guide a thin plastic tube into an arm vein and a dye will be injected.\n* Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and legs. They record heart activity.\n* Chest X-ray.\n* Tests of memory, attention, concentration, thinking, and movement.\n* Eligible participants will have DBS surgery. The surgery and hospital care afterward are NOT part of this protocol.\n* Study doctors will see participants 3 4 weeks after surgery to turn on the neurostimulator.\n* Participants will return every month for 3 months, then every 3 months during the first year, and every 6 months during the second year. Each time, participants will be examined and answer questions. DBS placement will be evaluated with MRI. The neurostimulator will be programmed. At two visits, participants will have tests of movements, thinking, and memory.",[113],"Parkinson's Disease",[115,116,113,117,118],"Deep Brain Stimulation","Movement Disorders","Essential Tremor","Tourette Syndrome",{"date":38,"type":39},{"date":121,"type":39},"2014-04-02",{"date":123,"type":22},"2030-12-01",{"name":45,"class":46},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":47},"100552402","early-phase-1-functional-neuroimaging-to-detect-the-neural-signatures-of-the-unpleasantness-of-pain-and-effort-100552402","NCT06472622","Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort","* INCLUSION CRITERIA:\n\nHealthy Controls: In order to be eligible to participate in this study as a healthy control, an individual must meet all the following criteria:\n\n1. Ability of subject to understand and the willingness to sign a written informed consent document.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, aged 18-50 (inclusive).\n4. Good general health as evidenced by medical history and\u002For physical examination.\n\nME\u002FCFS Patients: In order to be eligible to participate in this study as an ME\u002FCFS patient, an individual must meet all the following criteria:\n\n1. Ability of subject to understand and the willingness to sign a written informed consent document.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, aged 18-50 (inclusive).\n4. Has a diagnosis of ME\u002FCFS, meeting at least one of three ME\u002FCFS criteria: the 1994 Fukuda Criteria, the 2003 Canadian Consensus Criteria for Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome, or the Institute of Medicine Diagnostic Criteria.\n\nEXCLUSION CRITERIA:\n\nHealthy Controls:\n\n1. Any current major neurological or psychiatric disorder such as (but not limited to) stroke, Parkinson s disease, Alzheimer s disease, schizophrenia, or major depressive disorder.\n2. Any other current major medical disorder, such as a kidney disease, liver disease, cardiovascular disease, chronic pain condition, or any other disorder which, in the opinion of the PI would make participation risky for the individual or negatively affect the individual s ability to cooperate with study procedures.\n3. Current use of medications acting primarily on the central nervous system, such as antidepressants, stimulants, etc.\n4. Use of opioid medications for more than two weeks within the last two years or any use in the last month.\n5. Current or history of substance use disorder, binge drinking, illegal drug use, or excessive tobacco use (defined as more than 10 cigarettes of nicotine per week).\n6. Any more than occasional use of cannabis, defined as a score \\>1 (indicating use on more than one or two days in the last two weeks) on the marijuana use item of the DSM-5 Level 2-Substance Use-Adult questionnaire.\n7. Any use of other illicit drugs or misuse of prescription medications, defined as a score \\>0 on any of the other items of the DSM-5 Level 2-Substance Use-Adult questionnaire.\n8. Condition or injury affecting grip.\n9. Condition or injury affecting extremities that would alter peripheral sensitivity to painful thermal stimuli or would otherwise cause such stimuli to be contraindicated.\n10. Contraindications to MRI, including ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body, implanted cardiac pacemaker, auto-defibrillator, or pump, non-removable body piercing, claustrophobia, inability to lie supine for 90 minutes, known pregnancy, or plans to become pregnant during the study.\n11. Members of the NINDS BNU and their family members.\n12. Non-English speakers will be excluded from the study as several study instruments do not have validated translations.\n\nME\u002FCFS Patients:\n\n1. Any current major neurological or psychiatric disorder, other than ME\u002FCFS, such as (but not limited to) stroke, Parkinson s disease, Alzheimer s disease, schizophrenia, or major depressive disorder.\n2. Any other current major medical disorder, other than ME\u002FCFS, such as a kidney disease, liver disease, cardiovascular disease, chronic pain condition, or any other disorder which, in the opinion of the PI would make participation risky for the individual or negatively\n\n   affect the individual s ability to cooperate with study procedures.\n3. Current use of psychomotor stimulants, antipsychotics, or benzodiazepines.\n4. Use of opioid medications for more than two weeks within the last two years or any use in the last month.\n5. Current or history of substance use disorder, binge drinking, illegal drug use, or excessive tobacco use (defined as more than 10 cigarettes of nicotine per week).\n6. Any more than occasional use of cannabis, defined as a score \\>1 (indicating use on more than one or two days in the last two weeks) on the marijuana use item of the DSM-5 Level 2-Substance Use-Adult questionnaire.\n7. Any use of other illicit drugs or misuse of prescription medications, defined as a score \\>0 on any of the other items of the DSM-5 Level 2-Substance Use-Adult questionnaire.\n8. Condition or injury affecting grip.\n9. Condition or injury affecting extremities that would alter peripheral sensitivity to painful thermal stimuli or would otherwise cause such stimuli to be contraindicated.\n10. Contraindications to MRI, including ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body, implanted cardiac pacemaker, auto-defibrillator, or pump, non-removable body piercing, claustrophobia, inability to lie supine for 90 minutes, known pregnancy, or plans to become pregnant during the study.\n11. Members of the NINDS BNU and their family members.\n12. Non-English speakers will be excluded from the study as several study instruments do not have validated translations.","50 Years",{"count":133,"type":22},47,[135],"EARLY_PHASE1","Background:\n\nThe way the brain processes rewards and punishments may play a role in some disorders of the nervous system. People with chronic overlapping pain conditions (such as myalgic encephalomyelitis\u002Fchronic fatigue syndrome \\[ME\u002FCFS\\]) may have heightened responses to unpleasant, punishing sensations. Some of these conditions may also cause heightened responses to effort; this is an unpleasant sensation felt during physical and mental exertion.\n\nObjective:\n\nTo learn more about how the brain processes different unpleasant sensations.\n\nEligibility:\n\nPeople aged 18 to 50 years with ME\u002FCFS. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 3 visits in 1 to 5 weeks.\n\nVisit 1: Participants may have a neurologic exam. They will have a mock magnetic resonance imaging (MRI) scan. They will lie on a bed in a wooden tube while they practice 2 tasks:\n\nThermal pain rating: A device that creates mild to moderate heat will be placed on one leg.\n\nPhysical effort rating: Participants will squeeze a plastic bar with different levels of force.\n\nVisit 2: Participants will have a real MRI scan. They will lie on a table that slides into a large tube.\n\nVisit 3: Participants will have another MRI scan. They will repeat the thermal pain and physical effort tasks while in the scanner. Sensors will be placed on 1 arm to measure how the muscles function as they squeeze the bar.\n\nTheir heart rate will be tested: They will hold their finger against a camera lens for 1 minute. They will do 2 other tasks: 1 requires repeatedly pressing a key on a keyboard, and the other requires squeezing a bar.",[138],"Fatigue Syndrome, Chronic",[140,138,141,142,143,144,145,146,147,148],"Punishment","Pain","Physical Exertion","Effort","Brain","Magnetic Resonance Imaging","Neuroimaging","Psychophysics","Reward","2026-08-19",{"date":36,"type":39},{"date":152,"type":39},"2025-04-09",{"date":154,"type":22},"2034-06-30",{"name":45,"class":46},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":163,"maxAge":19,"enrollmentInfo":164,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":47},"100242555","inflammatory-and-infectious-diseases-of-the-nervous-system-100242555","NCT02435810","Inflammatory and Infectious Diseases of the Nervous System","Natural History Study of Inflammatory and Infectious Diseases of the Nervous System","* INCLUSION CRITERIA:\n\nAt the time of enrollment, participants will:\n\n1. Have a known or suspected infection or inflammation of the nervous system or post infection sequelae based on clinical or imaging data provided by the referral facility. For the purpose of this study, neuroinfectious disease or neuroinflammation is defined as any of the following:\n\n   1. fever with nervous system signs or symptoms (excluding delirium)\n   2. any neurological symptoms accompanied by cerebrospinal fluid (CSF) with evidence of inflammation (which may include pleocytosis, hypoglycorrachia, elevated protein, or other evidence of intrathecal immune activation including IgG index or presence of oligoclonal bands)\n   3. systemic infection or inflammatory disease with neurological involvement\n   4. neuroimaging suggestive of infection or inflammation (for example, presence of contrast-enhancing lesions on CT or MRI)\n   5. clinical presentation suggestive of infection or inflammatory process of the nervous system without better explanation\n   6. history of infection or inflammatory process of the nervous system\n2. Be willing to participate in the protocol s procedures, unless clinically contraindicated\n3. Be willing to provide informed consent, either directly or via appointed legally authorized representative\n4. Be willing to consent for collection of clinical data or biological samples or their cryopreservation\n5. Be at least 2 years old\n\nINCLUSION CRITERIA FOR PROCESSING OF BIOLOGICAL SAMPLES ONLY:\n\nAt the time of enrollment, participants will:\n\n1. Have a known or suspected infection or inflammation of the nervous system or post infection sequelae based on clinical or imaging data provided by the referral facility. For the purpose of this study, neuroinfectious disease or neuroinflammation is defined as any of the following:\n\n   1. fever with nervous system signs or symptoms (excluding delirium)\n   2. any neurological symptoms accompanied by cerebrospinal fluid (CSF) with evidence of inflammation (which may include pleocytosis, hypoglycorrachia, elevated protein, or other evidence of intrathecal immune activation including IgG index or presence of oligoclonal bands)\n   3. systemic infection or inflammatory disease with neurological involvement\n   4. neuroimaging suggestive of infection or inflammation (for example, presence of contrast-enhancing lesions on CT or MRI)\n   5. clinical presentation suggestive of infection or inflammatory process of the nervous system without better explanation\n   6. history of infection or inflammatory process of nervous system\n2. Be willing to provide informed consent, either directly or via appointed legally authorized representative\n3. Be willing to consent for collection of clinical data or biological samples or their cryopreservation\n4. Be at least 2 years old\n\nEXCLUSION CRITERIA:\n\nAt the time of enrollment, participants will:\n\n1. Not have a clinically significant medical condition that, in the best judgment of the investigators, may expose the patient to undue risk of harm or prevent the patient from completing the study (examples include, but are not limited to, ischemic cardiomyopathy, clotting disorder, brittle diabetes)\n2. Not have an acute or unstable medical condition that, in the best judgement of the investigator, would be difficult to handle at the NIH Clinical Center\n3. Not have a clearly-established diagnosis of well-characterized disease entity with validated treatment algorithms for which proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge\n\nEXCLUSION CRITERIA FOR PROCESSING OF BIOLOGICAL SAMPLES ONLY:\n\nAt the time of enrollment, participants will not have:\n\n1\\. A clearly-established diagnosis of well-characterized disease entity with validated treatment algorithms for which proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge\n\nINCLUSION CRITERIA FOR FAMILY MEMBERS:\n\n1. Have a family member enrolled on 15-N-0125\n2. Be at least 2 years old\n3. Be able to provide informed consent and comply with study procedures\n\nEXCLUSION CRITERIA FOR FAMILY MEMBERS:\n\n1\\. Not willing to consent for collection of biological samples or their cryopreservation","2 Years",{"count":165,"type":22},1000,"Background:\n\n\\- Inflammation is how the body reacts to infection or injury. Infections or inflammation in the brain and nerves can be serious. There aren t always good tests to detect this. Researchers want to learn more about how diseases affect the brain and nerves to develop better tests and treatments.\n\nObjective:\n\n\\- To learn more about how inflammation and infections hurt the brain and nervous system.\n\nEligibility:\n\n\\- People at least 2 years old with a diagnosis or suspected diagnosis of nervous system infection or inflammation.\n\nDesign:\n\n* For some participants, a clinician outside of NIH will collect blood, tissue, and other samples. These will be sent to NIH and analyzed.\n* Other participants will have several visits to NIH. Children may not have all these tests.\n* Participants will have:\n* Medical history.\n* Physical and neurological exam.\n* Blood and urine samples collected.\n* Saliva collected. They will chew on a piece of sterile cotton for one minute.\n* Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will get a contrast agent through an intravenous (IV) catheter during the MRI. A needle will be used to guide a thin plastic tube (catheter) into an arm vein.\n* Lumbar puncture. Skin will be numbed and a needle will be inserted into the space between the bones in the back. Fluid will be removed.\n* Some participants may have optional study procedures. These may include eye tests, memory and thinking testing, tests with electrodes on the head, or skin biopsy.",[86],[169,170,171],"Neuroinflammation","Infections","Natural History",{"date":36,"type":39},{"date":174,"type":39},"2015-05-06",{"date":176,"type":22},"2026-11-29",{"name":45,"class":46},{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":184,"sex":17,"minAge":18,"maxAge":106,"enrollmentInfo":185,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":47},"100485704","assessing-and-improving-quantitative-magnetic-resonance-imaging-metrics-in-human-subjects-100485704","NCT05604534","Assessing and Improving Quantitative Magnetic Resonance Imaging Metrics in Human Subjects","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 18 years of age and older\n* In good general health as evidenced by medical history\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Must have had a neurological physical exam as prescribed by NINDS policy. At the time of writing, this is required at least once every 2 years, and record of the exam should be in the medical record. This exam must be done prior to having MRI # 1. If deemed adequate by the Investigators, reports of examination by clinicians who are not Investigators on this study may be used. In addition, subjects must complete the most-recent version of the NMR safety screening form or NIH Radiology and IS MRI safety questionnaire when required at each visit.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Has any metal implant or objects of unknown identity or composition, or if it s known to be non-compatible with MRI, such as pacemakers, medication pumps, aneurysm clips, metallic prosthesis (such as heart valves or cochlear implants), certain orthopedic implants (pins and rods), shrapnel, or small metal fragments in the eye;\n* Has claustrophobia to a degree that would preclude lying comfortably in the scanner for the duration of the examination;\n* Cannot lie comfortably for up to 120 minutes;\n* Has hearing problems which would make it difficult to tolerate scanner noise;\n* Subjects with tattoos or permanent eye liner; liner; will not be excluded, however, tattoos carry a small risk of heating and burns. Therefore, each tattoo will be considered on a case by case basis, taking into account the age of the tattoo and the location of the tattoo on the subject s body.\n* Has medical health problems such as pulmonary or airway disease, heart failure, coronary artery disease, which would require physiological monitoring during the scan;\n* History of any medical condition that could result in an emergency medical situation while undergoing the MRI scan;\n* For \\>7T: Has a ferromagnetic dental crown or a bridge.\n* Non-English speakers are excluded as it is important that volunteers understand the complex instructions required to undergo an MRI procedure, and there is no direct benefit to participants.\n* Pregnant women:\n\n  * a) If a woman is pregnant at the time of enrollment, we will popstpone enrollment until she is no longer pregnant.\n  * Participants will not remain on the study should they have a positive pregnancy test at a study visit.",true,{"count":186,"type":22},200,"Background:\n\nMagnetic resonance imaging (MRI), which uses strong magnets to get images of structures inside the body, is a valuable tool in modern medicine. But researchers are always looking for ways to improve this technology. To better understand how to use MRI to diagnose problems, researchers need to collect more data from scans of healthy people.\n\nObjective:\n\nTo get MRI scans of healthy people to improve the measurements doctors can make from the images.\n\nEligibility:\n\nPeople aged 18 years or older in good general health.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam focused on their nervous system. They will complete questionnaires.\n\nParticipants will have at least 1 MRI scan. The target of the scan may be the brain, liver, prostate, breast, or other body part. Before the scan, participants will remove any metallic objects. They will lie on a narrow table that moves into a long, narrow tube. They may have special pads placed around them to help them remain still.\n\nParticipants will hear loud noises during the scan. They will get earplugs or earmuffs to wear to muffle the sound. They can communicate with the MRI technician and will have an emergency button to squeeze at any time if they want the scan to stop. The scan will take up to 2 hours.\n\nSome participants may be asked to perform tasks on a computer screen during the scan.\n\nParticipants may return for up to 5 scans in 3 months. Some may have as many as 30 MRI visits per year. They may remain in the study for up to 2 years.",[189],"Normal Physiology",[191,192,193,194,195,171],"MRI","Healthy Adult","Diffusion","DTI","Diffusion Tensor Imaging","2026-08-15",{"date":198,"type":39},"2026-08-18",{"date":200,"type":39},"2023-02-02",{"date":202,"type":22},"2041-03-31",{"name":45,"class":46},{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":184,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":210,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":212,"conditions":213,"keywords":217,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":47},"100457544","investigational-use-of-neuromuscular-ultrasound-100457544","NCT05237973","Investigational Use of Neuromuscular Ultrasound","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Healthy Volunteers-Adults\n\n   1. Healthy adults, male or female, aged 18 years old or older,\n   2. In good general health as evidenced by medical history, medical conditions under control such as hypertension acceptable.\n   3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n   4. Ability of subject to understand and the willingness to sign a written informed consent document.\n2. Participants with neuromuscular disorders\n\n   1. Adults, male or female, aged 18 years old or older,\n   2. Diagnosed with a neuromuscular disorder or have signs and symptoms of nerve or muscle disorder or neuromuscular diaphragm dysfunction.\n   3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n   4. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Healthy Volunteers-Adults\n\n   History of stroke, muscle disorders, peripheral neuropathy, or spine surgery\n2. Participants with neuromuscular disorders\n\nNo clinical evidence of a neuromuscular disorder on clinical evaluation.",{"count":211,"type":22},150,"Background:\n\nCurrent techniques used to measure the health and function of a person s nerves and muscles are generally effective, but they do have limits. Researchers are looking for ways to improve the ability to observe nerves and muscles and how they function in this natural history protocol.\n\nObjective:\n\nTo study the use of ultrasound (sound waves) to learn more about nerves and muscles.\n\nEligibility:\n\nHealthy adults, aged 18 and older, with no history of stroke, nerve or muscular disorders, or spine surgery are also needed. A smaller population of adults aged 18 and older who have a neuromuscular disorder or show symptoms of nerve or muscle disorder will also be evaluated.\n\nDesign:\n\nParticipants will be screened with a medical record review.\n\nParticipants will have up to 5 outpatient clinic visits. Most participants will have 1 or 2 visits. Visits will last for less than 3-4 hours each.\n\nDuring each visit, participants will give a brief medical history and have a physical exam.\n\nParticipants will have ultrasounds to get pictures and measurements of their nerves and muscles. Gel will be applied to their skin. A probe will be placed on the skin surface. Sound waves sent through the probe will be used to create pictures.\n\nParticipants may have nerve conduction studies. Wires will be taped to the skin surface near a muscle or nerve in the arm or leg. The nerve will be stimulated with a small electric current that feels like a rubber band flick. The response will be recorded through the wires.",[214,215,216,189],"Muscular Dystrophy","Peripheral Neuropathy","Motor Neuron Disorder",[218,219,220,221,222,171],"Neuromuscular","Ultrasound","Elastography","Muscle","Nerve",{"date":198,"type":39},{"date":225,"type":39},"2022-04-18",{"date":227,"type":22},"2027-08-03",{"name":45,"class":46},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":184,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":236,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":47},"100386468","the-beneficial-effects-of-naps-on-motor-learning-100386468","NCT04312126","The Beneficial Effects of Naps on Motor Learning","Mechanisms Underlying the Beneficial Effects of Naps on Motor Learning","* HEALTHY VOLUNTEERS:\n\nINCLUSION CRITERIA:\n\n* Age 18-35 (Arm 1) or 50-80 (Arms 2).\n* English speaking.\n* Clear right-hand dominance (\\>74 on Edinburgh Handedness Inventory).\n* Normal neurological examination as determined by the screening clinician.\n\nEXCLUSION CRITERIA:\n\n* HCPS affiliated NIH staff (i.e. - staff from our section).\n* Current pregnancy.\n* Contraindications for MRI or MEG.\n* Use of sleep medications within 24 hours of Experimental Session participation.\n* Severe or progressive neurological, psychological or medical condition as determined by the screening clinician.\n\nSTROKE PATIENTS:\n\nINCLUSION CRITERIA:\n\n* Age 18 or older\n* Willing and able to provide consent\n* Experienced a stroke 6 months ago or more that affected at least one of the upper extremities at time of stroke diagnosis\n* Ability to perform the study task as assessed during physical examination\n* English-speaking\n\nEXCLUSION CRITERIA:\n\n* HCPS-affiliated NIH staff (i.e. - staff from our section).\n* Current pregnancy\n* History of large stroke lesions in brainstem or cerebellum as determined by screening clinician\n* Severe or progressive neurological disorder other than stroke (e.g., Parkinson s disease or multiple sclerosis) as determined by the screening clinician\n* Uncontrolled heart, lung, kidney, gastrointestinal, metabolic, psychiatric, sleep, or endocrine disorders as determined by the screening clinician\n* Contraindications for MRI or MEG.",{"count":237,"type":22},199,"Background:\n\nMemory consolidation is the process by which memories become stable, long-term representations in the brain. Consolidation of a motor skill is dependent upon sleep. Some research shows that daytime naps improve people s motor performance and memory retention. Researchers want to find out how daytime naps may contribute to learning and support consolidation of motor skill memories.\n\nObjective:\n\nTo learn the role of memory replay during wakeful rest and sleep (naps) in retaining a newly learned skill.\n\nEligibility:\n\nEnglish-speaking adults ages 18 and older with chronic stroke, or healthy, right-handed, English-speaking adults ages 18-35 and 50-80\n\nDesign:\n\nParticipants will be screened with:\n\n* medical history\n* neurological history\n* medicine review\n* medical exam\n* neurological exam.\n\nParticipants will have a magnetic resonance imaging (MRI) scan of the brain. For this, they will lie down in a scanner. The scanner makes loud noises, so they will wear earplugs. They will fill out an MRI screening form before each MRI.\n\nParticipants will also have magnetoencephalography (MEG). MEG maps brain activity. It does this by recording the magnetic fields produced by naturally occurring electrical currents in the brain. For MEG, participants will lie down in the MEG room. Their eye movements may be recorded by a video camera.\n\nParticipants will have behavior testing. They will practice typing random keys. Then they will repeatedly type a custom sequence that they see on a computer screen. Then they will take a 2-hour nap. Then they will type the same sequence again.\n\nParticipants will have no more than 4 visits at the NIH over 3 months. Visits will last 2-4 hours each.",[85],[241,242,243,171],"Motor Skill","Sleep","Neural Replay",{"date":198,"type":39},{"date":246,"type":39},"2021-03-04",{"date":248,"type":22},"2027-08-01",{"name":45,"class":46},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":256,"maxAge":80,"enrollmentInfo":257,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":4,"leadSponsor":270,"locationsCount":47},"100062447","evaluation-and-treatment-of-neurosurgical-disorders-100062447","NCT00060541","Evaluation and Treatment of Neurosurgical Disorders","* INCLUSION CRITERIA:\n\n  1. Participants must be age 4 and older.\n  2. Participants must seek care from, or be referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions (such as central nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movement disorders, Chiari syndrome, central nervous system malformations, and pain disorders)\n  3. For adults: able to provide informed consent or having a legally-authorized representative to provide consent, if incapacitated\n  4. For minors: a parent or legal guardian who is able to provide consent.\n\n     For immediate blood relatives of subjects having genetic testing only:\n  5. Blood relative of a subject who is suspected to have a genetic mechanism underlying their neurological disorder (for genetic testing only).\n\nEXCLUSION CRITERIA:\n\n1\\. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder\n\n3.c. Participant Inclusion Criteria for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and\u002For saliva samples)\n\n1. Participants must be age 4 and older.\n2. Participants must seek care from or be referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions (such as central nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movement disorders, Chiari syndrome, central nervous system malformations, and pain disorders)\n3. For adults: able to provide informed consent or having a legally-authorized representative to provide consent, if incapacitated\n4. For minors: a parent or legal guardian who is able to provide consent.\n5. Be willing to consent for collection of clinical data or biological samples or their cryopreservation\n\n3.D. Participant Exclusion Criteria for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and\u002For saliva samples)\n\n1. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder\n2. At the time of enrollment, subjects without an established diagnosis of a wellcharacterized disease entity with validated treatment algorithms. In such cases, proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge","4 Years",{"count":258,"type":22},5000,"Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment. The clinical data and samples generated during standard of care treatment will be collected as part of this study.\n\nStudy Population: Participants 4 years of age and older with neurosurgical-related conditions, who are seeking care from or referred to the Surgical Neurology Branch for evaluation, are eligible for this protocol.\n\nStudy Design: This is an observational study. Participants will receive standard-of-clinical-care evaluation and treatment for their neurosurgical condition. Clinical evaluation may include laboratory and radiological studies designed to aid in diagnosis or differential diagnosis of the participant s condition or to facilitate treatment. The evaluations may take place in the outpatient clinic areas or in the inpatient units. Some participants will receive standard-of-care medical or surgical treatment for their disorder. Clinical data, tissue samples or body fluids obtained during standard of care treatment, may be used for research. Additional genetic testing may be performed on subjects and their blood relatives if a genetic mechanism underlying the neurological disorder is suspected. Patients in this study may choose to consent to skin biopsies for research purposes, in which case they will sign an additional consent document for this research procedure.\n\nOutcome Measures: No additional research outcome measures will be tracked in this study, as this study is collecting data for potential future use. All outcomes will be those of standard clinical evaluation and treatment. A clinical and research database will be kept of patient s diagnosis, progression, and treatment. Clinical database information may be reported or be used in other studies.",[261],"Neurologic Disorders",[263,264,265,113,266,171],"Brain Tumor","Epilepsy","Pituitary Adenoma","Spinal Cord Tumor",{"date":198,"type":39},{"date":269,"type":39},"2003-06-04",{"name":45,"class":46},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":163,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":281,"conditions":282,"keywords":286,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":4,"leadSponsor":291,"locationsCount":292},"100057066","study-of-inherited-neurological-disorders-100057066","NCT00004568","Study of Inherited Neurological Disorders","Clinical and Molecular Manifestations of Inherited Neurological Disorders","* Participants include those with inherited neurological conditions based on the training and research needs of the Neurogenetics Branch program. There is no logical limit; however the total number of participants that can be enrolled in the protocol will be restricted. No more than 3,500 participants with either diagnosed or undiagnosed neurological conditions and their unaffected relatives will be enrolled in this evaluation and diagnostic protocol.\n\nINCLUSION CRITERIA:\n\nParticipants will be eligible if they:\n\n* Have either a known or suspected, inherited neurological disease, OR are an unaffected relative (first-, second-, third, or higher degree relative) of a participant with a genetic neurological disease.\n* Have the ability to understand and sign an informed consent or have a parent\u002Flegal guardian to do so if they are minor children or a legal guardian to provide consent for adults without consent capacity.\n* Aged 2 years and above.\n\nEXCLUSION CRITERIA:\n\nParticipants will not be eligible if they:\n\n-Have a systemic disease that compromises the ability to provide adequate neurologic examination or diagnosis.An example of this would be a contagious disease that would compromise our ability to do an adequate neurological exam.","120 Years",{"count":280,"type":22},3500,"This study is designed to learn more about the natural history of inherited neurological disorders and the role of heredity in their development. It will examine the genetics, symptoms, disease progression, treatment, and psychological and behavioral impact of diseases in the following categories: hereditary peripheral neuropathies; hereditary myopathies; muscular dystrophies; hereditary motor neuron disorders; mitochondrial myopathies; hereditary neurocognitive disorders; inherited neurological disorders without known diagnosis; and others. Many of these diseases, which affect the brain, spinal cord, muscles, and nerves, are rare and poorly understood.\n\nChildren and adults of all ages with various inherited neurological disorders may be eligible for this study. Participants will undergo a detailed medical and family history, and a family tree will be drawn. They will also have a physical and neurological examination that may include blood test and urine tests, an EEG (brain wave recordings), psychological tests, and speech and language and rehabilitation evaluations. A blood sample or skin biopsy may be taken for genetic testing. Depending on the individual patient s symptoms, imaging tests such as X-rays, CT or MRI scans and muscle and nerve testing may also be done.\n\nInformation from this study may provide a better understanding of the genetic underpinnings of these disorders, contributing to improved diagnosis, treatment, and genetic counseling, and perhaps leading to additional studies in these areas.\n\n...",[283,284,214,285],"Motor Neuron Disease","Muscular Disease","Peripheral Nervous System Disease",[287,214,283],"Myopathy",{"date":198,"type":39},{"date":290,"type":39},"2000-02-18",{"name":45,"class":46},2,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":184,"sex":17,"minAge":18,"maxAge":278,"enrollmentInfo":300,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":4,"leadSponsor":310,"locationsCount":47},"100054316","magnetic-resonance-imaging-mri-to-evaluate-activity-of-multiple-sclerosis-ms-100054316","NCT00001248","Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)","Evaluation of Progression in Multiple Sclerosis by Magnetic Resonance Imaging (MRI)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. One of the following:\n\n   1. Affected participant with either a diagnosis of MS based on currently accepted diagnostic criteria, or imaging or clinical abnormalities associated with MS.\n   2. Healthy volunteer.\n2. Age \\>=18\n3. Able to give informed consent.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Contraindication to MRI at the time of initial enrollment (with the exception of pregnancy).\n2. Unwilling to allow coded samples to be processed offsite or unwilling to have coded samples used in other studies.",{"count":301,"type":22},3750,"Studies performed under 89-N-0045 are designed to examine the natural history of multiple sclerosis (MS) using MRI and immunological measures. In addition to studying the natural history of untreated patients, the natural history of patients receiving approved disease-modifying therapies of MS will be examined. In both cohorts of patients levels of disease activity on MRI will be compared with immunological characteristics in order to help identify disease mechanism. Patients with either definite MS (based either on clinical or combined clinical and MRI criteria) or with an initial presentation of neurological dysfunction consistent with MS will be studied longitudinally by MRI. Disease activity on MRI will be assessed using several MRI measures of disease activity including the number of contrast enhancing lesions, the overall burden of disease, brain atrophy and measures to assess axonal damage. Patients will be assessed clinically and correlations between immunological and genetic factors and disease activity as seen clinically or by MRI will be studied.\n\nA second cohort of patients starting the use of approved therapy will also be examined. Patients referred to NIH prior to beginning approved therapy will be assessed with a series of three monthly MRIs to determine the level of pretreatment disease activity. After beginning approved therapy under the direction of their private physician, patients will be followed similarly to the natural history cohort. Immunological and genetic findings will be accessed before and during therapy in order to help establish the mechanisms of action of the therapies and to identify mechanisms accounting for either a response or lack of response to therapy. Part of the collected samples willl be cryopreserved to provide respository for further studies focusing on detection of biomarkers indicative of disease state, disease stage or repsonse to therapies.\n\nAdditionally, a cohort of normal volunteers will be studied. The studies in the normal volunteers will be used to establish the most appropriate imaging sequences for studying normal white matter in MS patients using magnetization transfer (MT) imaging sequences for studying normal white matter in MS patients using magnetization transfer (MT) imaging and to provide normative immunological measures.\n\n...",[304],"Multiple Sclerosis",[304,306,171],"MRI (Magnetic Resonance Imaging)",{"date":198,"type":39},{"date":309,"type":39},"1992-07-23",{"name":45,"class":46},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":47},"100249911","phase-1-investigation-of-blood-brain-barrier-breakdown-using-manganese-magnetic-resonance-imaging-in-drug-resistant-epilepsy-100249911","NCT02531880","Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy","* INCLUSION CRITERIA:\n* Age 18-60.\n* Able to give written informed consent directly.\n* Drug resistant epilepsy participants will be defined as having clinically documented seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, refractory to standard anti-seizure treatment for at least one year prior to enrolling in this study and with an average of at least one seizure per month. This criterion will be established by preliminary screening NINDS Epilepsy Service under protocol 18-N-0066. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies. Prior or concurrent enrollment in 18-N-0066 is required.\n\nEXCLUSION CRITERIA:\n\nGeneral exclusions:\n\n* Patients with epilepsy who are not surgical candidates\n* Significant structural brain abnormality such as a brain tumor, stroke, brain damage from head trauma or blood vessel abnormalities, on the baseline MRI scan.\n* Positive test for HIV\n* Pregnancy or breast-feeding\n* Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine.\n* Cannot lie on their back for at least two hours.\n* Risk for MRI scan, (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed, or history of being a welder or metal worker due to small metal fragments in the eye)\n* Unwilling to allow sharing and\u002For use in future studies of coded data that are collected for this study\n\nMEMRI component specific exclusions (applicable only to patients participating in this arm of the study):\n\n* History of post-ictal psychosis or post-ictal aggression\n* Planning to get pregnant in the next 2 months\n* History of clinically significant liver or kidney disease that could potentially increase the risk of CNS damage due to manganese exposure\n* A history of drug or alcohol abuse\u002Fdependence (subjects scoring 8 or higher on the AUDIT scale)\n* Screening lab abnormalities demonstrating values more than 2 times the upper limit of normal for AST, ALT, bilirubin, alkaline phosphatase, BUN, creatinine\n* Previous presumed occupational exposure to manganese (i.e., having worked in a mine, foundry, smelter, dry cell battery manufacturing facility, or agriculture)\n* Allergy to manganese\n* On-going treatment with calcium-channel blocker\n* Iron-deficiency anemia\n* Personal history of Parkinson s Disease or Parkinsonism or presence of this disease in a 1st degree relative\n\nGadolinium enhanced MRI component specific exclusions (applicable only to patients participating in this arm of the study):\n\n* Estimated GFR \\\u003C60, tested within 1 week of scan\n* Allergy to gadolinium\n\nOf note, patients who are ineligible for one arm of the study may still be eligible for and participate in the other arm of the study.","60 Years",{"count":319,"type":22},40,[25],"Background:\n\n\\- The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a neurological disease that causes seizures. It can affect this barrier. Researchers think a contrast agent called mangafodipir might be better able to show areas of the brain that epilepsy affects.\n\nObjective:\n\n\\- To see if mangafodipir is well tolerated and safe. To see if magnetic resonance imaging (MRI) using either mangafodipir or gadolinium can show areas of blood-brain barrier breakdown in people with epilepsy.\n\nEligibility:\n\n* People ages 18-60 who:\n* Have epilepsy not controlled by drugs\n* Prior or concurrent enrollment in 18-N-0066 is required\n\nDesign:\n\n* Participants will be screened with:\n* Medical history\n* Physical exam\n* Blood and urine tests\n* Participants will have up to 6 visits in 1-3 months. One visit is an inpatient stay lasting 2-10 days. Visits may include:\n* Video-EEG monitoring for participants with epilepsy\n* An IV catheter put in place: a needle guides a thin plastic tube into an arm vein.\n* Getting mangafodipir through the IV.\n* Getting gadolinium through the IV.\n* Up to 6 MRI scans over a 10-day period: a magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides into a metal cylinder. They are in the cylinder for 45-90 minutes, lying still for up to 10 minutes at a time. The scanner makes loud knocking sounds. Participants will get earplugs.\n* A final MRI at least 2 weeks after receiving mangafodipir....",[264],[191,324,325,326,327],"Manganese Enhanced MRI","Seizure Disorder","Seizures","Epileptic Focus","2026-08-14",{"date":330,"type":39},"2026-08-17",{"date":332,"type":39},"2024-11-19",{"date":334,"type":22},"2030-07-01",{"name":45,"class":46},{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":278,"enrollmentInfo":343,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":345,"conditions":346,"keywords":349,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":4,"leadSponsor":355,"locationsCount":356},"100058931","natural-history-of-stroke-cause-and-development-100058931","NCT00009243","Natural History of Stroke: Cause and Development","Evaluation, Pathogenesis, and Treatment of Patients With or at Risk for Cerebrovascular Disease (A Natural History\u002FDisease Pathogenesis Protocol)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Aged \\>=18\n2. Presented to participating study site (ED, ICU, or inpatient unit) with or at risk of acute stroke, TIA, or other disturbances of cerebrovascular circulation\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Subjects with contraindication to MRI scanning will be excluded from any testing which involves the use of MRI. The contraindications include subjects with the following devices or conditions:\n\n   * Central nervous system aneurysm clips\n   * Implanted neural stimulator\n   * Implanted cardiac pacemaker or defibrillator\n   * Cochlear implant\n   * Ocular foreign body (e.g. metal shavings)\n   * Insulin pump\n   * Metal shrapnel or bullet\n   * Any implanted device that is incompatible with MRI\n\n   Subjects with a condition precluding entry in the scanner (e.g. morbid obesity, Claustrophobia, etc.) will not be included in the MRI portion of this study.\n2. Pregnancy",{"count":344,"type":22},4000,"The purpose of this study is to learn more about stroke and obtain information that may serve as the basis for future investigations. It will 1) establish a registry of patients with cerebrovascular disease (stroke); 2) characterize the natural history of acute stroke and transient ischemic attacks (TIA)-an interruption of blood flow to the brain that causes stroke symptoms for a short period of time); and 3) evaluate the data to generate ideas for future studies.\n\nPatients 18 years of age or older with suspected acute stroke or TIA may be eligible for this study. Subjects will be recruited from patients who present with stroke at the emergency department of Suburban Hospital in Bethesda, Maryland.\n\nThe study will gather data collected from diagnostic and laboratory tests the patient undergoes as part of standard medical care, including findings of medical and neurological examinations and other tests. In addition, studies will be done for research purposes only to gather data about stroke and TIA. These may include the following:\n\n* Blood and urine tests not more than 2 tablespoons of blood will be drawn for various tests.\n* Electrocardiogram (EKG) (heart tracing)-electrodes placed on the chest wall detect the heartbeat and heart rhythm.\n* Computed tomography (CT) scan of the head-specialized X-rays are used to obtain images of the brain.\n* Magnetic resonance imaging (MRI) of the brain-a strong magnetic field and radio waves are used to produce images that provide information about the brain tissue and blood vessels.\n* Transcranial Doppler (TCD)-sound waves are used to image the arteries of the brain and neck.\n* Echocardiogram-sound waves are used to image the heart and evaluate heart function.\n\nPatients may be asked to return to Suburban Hospital for follow-up testing in 1, 3, and\u002For 12 months, when some of these tests may be repeated to assess changes over time\n\n...",[86,347,348,88,87],"Ischemic Attack, Transient","Cerebrovascular Accident",[85,171,306,145,350,351],"Acute Stroke","TIA",{"date":330,"type":39},{"date":354,"type":39},"2001-01-26",{"name":45,"class":46},3,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":163,"maxAge":106,"enrollmentInfo":364,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":366,"conditions":367,"keywords":368,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":4,"leadSponsor":374,"locationsCount":47},"100054279","botulinum-toxin-for-the-treatment-of-involuntary-movement-disorders-100054279","NCT00001208","Botulinum Toxin for the Treatment of Involuntary Movement Disorders","Botulinum Toxin for the Treatment of Neurological Disorders","* INCLUSION CRITERIA:\n\n  1. Patients 2 years and older, will be eligible for participation if they have a disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX.\n  2. Applicable disorders include but are not limited to dystonia, hemifacial spasm, blepharospasm, tremor, spasmodic dysphonia, tics, vocal fold tremor, oral lingual dyskinesia, tardive dyskinesia, spasticity, and spasmodic dysphonia.\n\nEXCLUSION CRITERIA:\n\n1. Women who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition.\n2. Subjects who require treatment with an aminoglycoside antibiotic, until treatment is complete.\n3. For laryngeal injections, subjects must have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders",{"count":365,"type":22},2000,"BTX has been used since the 1980s in support of the research mission of NINDS. Initial studies were focused on expanding the applicability of BTX treatment to movement disorders and exploring new indications. We evaluated the efficacy of an alternative serotype, type F. Under other protocols, we continue to study the physiology of movement disorders and BTX response.\n\nThe application of BTX therapy to movement disorders requires an understanding of BTX preparation and handling. The treatment must be tailored to the disorder under treatment and to its expression in the individual patient. Users must know the specific techniques of injection, including the use of EMG and ultrasound guidance. This protocol allows us to train physicians in all aspects of the use of BTX. It also provides us with a cohort of patients, receiving a standard method of treatment and with a stable response to BTX injection, for participation in other protocols on movement disorders and on the responses to BTX injection.",[116],[369,370,171],"Botulinum Toxin","BTW",{"date":330,"type":39},{"date":373,"type":39},"1989-10-26",{"name":45,"class":46},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":106,"enrollmentInfo":382,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":47},"100641109","longitudinal-natural-history-protocol-for-prkn--and-pink1-linked-pd-100641109","NCT07613112","Longitudinal Natural History Protocol for PRKN- and PINK1-Linked PD","Longitudinal Natural History Protocol for PRKN- and PINK1-linked PD","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAll participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female between the ages of 18-80 years old\n* Ability of subject to understand and the willingness to sign an informed consent document\n* Ability of subject to travel to the NIH Clinical Center\n\nAdditional inclusion criteria for each cohort as below:\n\nPD Mito - Biallelic:\n\n* Established clinical diagnosis of Parkinson's disease\n* Two Pathogenic or likely pathogenic variants in PRKN or PINK1\n\nPD Mito - Monoallelic:\n\n* Established clinical diagnosis of Parkinson's disease\n* One Pathogenic or likely pathogenic variant in PRKN and\u002For PINK1\n\nIdiopathic Parkinson's Disease (PD):\n\n* Established clinical diagnosis of Parkinson's disease\n* Etiology of PD is idiopathic\u002Fsporadic based on investigator determination\n\nNon-manifesting mito:\n\n* One or two pathogenic or likely pathogenic variant in PRKN and\u002For PINK1\n* Lack of clinical diagnosis of Parkinson's disease\n* Lack of current or clinically significant neurological disorder (based on investigator determination)\n\nHealthy Volunteer\n\n-Lack of current or clinically significant neurological disorder (based on investigator determination)\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nAll participants:\n\n* Symptomatic PD syndromes due to drugs (e.g., metoclopramide, flunarizine, neuroleptics), metabolic disorders (e.g., Wilson's disease hypothyroidism), encephalitis, brain lesion, atypical parkinsonism, other monogenic forms of PD (e.g., GBA1, LRRK2, SNCA, VPS35, CHCHD2, DJ1, ATP13A2) other genetic disorders that may cause parkinsonism (e.g., spinocerebellar ataxia, X-linked dystonia parkinsonism)\n* Pregnancy at time of study enrollment\n* Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment\n* Unwilling to allow samples or data to be shared with other researchers or institutions.\n* NIH staff or family members of study team members\n\nHealthy Volunteer:\n\n-Participants who become pregnant during the study will be withdrawn from further study procedures at the time pregnancy is identified.\n\nProcedural Exclusions:\n\nSubjects may still be enrolled if they cannot participate in certain procedures due to not meeting the inclusion requirements for that specific procedure. Subjects who meet exclusion criteria for procedures listed below may still undergo the procedure at a later time if the reason of exclusion is no longer present.\n\nBrain MRI:\n\n* Contraindications to MRI such as a contraindicated non-removable metal device (i.e., pacemaker, defibrillator, insulin pump, metal clips, non-removable jewelry)\n* Pregnancy\n\nAccelerometer:\n\n-Non ambulatory\n\nLumbar puncture procedure:\n\n* PT\u002FPTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)\n* INR greater than 1.4, thrombocytopenia (\\\u003C70,000), or abnormal bleeding time or platelet dysfunction\n* History of a bleeding disorder\n* Use of anticoagulants or antiplatelets\n* Pregnancy\n* History of headache requiring blood patch after a previous LP\n\nNeedle muscle biopsy:\n\n* PT\u002FPTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)\n* INR greater than 1.4, thrombocytopenia (\\\u003C70,000), or abnormal bleeding time or platelet dysfunction\n* History of a bleeding disorder\n* Use of anticoagulants or antiplatelets\n* Pregnancy",{"count":383,"type":22},70,"Background:\n\nParkinson s disease is a neurologic disorder that affects movement. Its cause is unknown, and it usually begins later in life. Gene changes (PRKN and PINK1) can also cause rare types of Parkinson s disease that start at a young age. Researchers want to conduct a natural history study to learn more about how genes play a role in Parkinson s disease.\n\nObjective:\n\nTo collect data and biological samples from people with different types of Parkinson s disease.\n\nEligibility:\n\nPeople aged 18 to 80 years with either Parkinson s disease or PRKN- and PINK1-linked Parkinson s disease. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 6 clinic visits over 5 years. Each visit may take 1 to 3 days.\n\nDuring each visit:\n\nParticipants will have a physical exam. The exam will be videotaped.\n\nThey will answer questions about their movement, thinking, mood, and sense of smell. The extent of any symptoms of Parkinson s disease will be evaluated: Participants movements may be assessed with a finger tapping test. They may be asked to scratch and sniff different scented strips to identify odors.\n\nThey will wear motion sensors on their arms, legs, chest, and back at the clinic. They will wear motion sensor devices on their wrists at home for 1 week.\n\nBlood and urine samples will be collected.\n\nOther tests are optional:\n\nMagnetic resonance imaging (MRI) scan of the brain. Participants will lie on a table that slides into a tube.\n\nLumbar puncture (spinal tap). A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.\n\nMuscle biopsy. A small sample of tissue will be taken from the leg.",[386],"PARKINSON DIS",[388,389,390],"PINK1","PRKN","PARKINSON","2026-08-12",{"date":393,"type":39},"2026-08-13",{"date":395,"type":22},"2026-10-01",{"date":397,"type":22},"2036-05-30",{"name":45,"class":46},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":406,"maxAge":80,"enrollmentInfo":407,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":47},"100564551","a-prospective-natural-history-and-outcome-measure-validation-study-of-congenital-myasthenic-syndromes-100564551","NCT06630650","A Prospective Natural History and Outcome Measure Validation Study of Congenital Myasthenic Syndromes","A Single Center Prospective Natural History and Outcome Measure Validation Study of Congenital Myasthenic Syndromes","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged \\>= 6 months of age\n* Clinically stable as evidenced by medical record review and remote screening questionnaire\n* Genetically confirmed congenital myasthenic syndrome (pathogenic or likely pathogenic variants identified by CLIA testing in an established CMS-related gene including but not limited to DOK7, COLQ, CHRNE, RAPSN, CHAT, GFPT1, DPAGT1 OR pathogenic\u002Flikely pathogenic variant in combination with a variant of uncertain significance (VUS) AND additional clinical supporting evidence of CMS).\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n* Ability of subject to understand and the willingness to provide informed consent (\\>=18 years of age) and assent (\\>=7 years of age).\n\nEXCLUSION CRITERIA:\n\n* Received gene transfer therapy\n* Pregnant women (prior to enrollment)\n* Ongoing medical condition or medication use that is deemed by the Principal Investigator to interfere with the conduct or assessments of the study or safety of the subject.","6 Months",{"count":56,"type":22},"Background:\n\nCongenital myasthenic syndromes (CMSs) are a group of inherited disorders that affect how the nerves communicate with muscles. These can cause many problems that affect how people can move and use their bodies.\n\nObjective:\n\nThis is a natural history study to learn more about how CMSs affect the body and cause changes over time.\n\nEligibility:\n\nPeople aged 6 months or older with a CMS. The study will focus on DOK7- and COLQ-related CMSs, as well as other forms.\n\nDesign:\n\nParticipants will have up to 7 visits in 5 years. At each visit, participants will undergo many tests, including:\n\nPhysical exam with blood and urine tests.\n\nTests of their heart and lung function.\n\nExams of the eyes, lungs, muscles, and nerves. These will be done with different specialists.\n\nExams of the arms and hands and of body use and movements. These will also be done with specialists.\n\nPhotos and videos may be taken.\n\nMuscle ultrasound. Participants will lie still as a wand is rubbed over their skin.\n\nMagnetic resonance imaging (MRI) scans. Participants will lie still on a bed that slides partway into a large tube. A parent or other person may remain in the room, too. The scan will take 60 minutes.\n\nElectromyography (EMG). Participants will lie still or may be asked to move around. A machine will measure the electrical activity in their muscles.\n\nAn activity monitor may be placed on the participant s wrist, ankle, or hip for up to 2 weeks. The monitor is about the size of a wristwatch.\n\nA sample of skin may be removed....",[410],"Myasthenic Syndromes, Congenital",[412,413,414,415,416],"Congenital Myasthenic Syndrome","Collagen Q","Downstream of tyrosine kinase 7","DOK7","COLQ",{"date":393,"type":39},{"date":419,"type":39},"2025-05-12",{"date":421,"type":22},"2044-12-02",{"name":45,"class":46},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":184,"sex":430,"minAge":18,"maxAge":278,"enrollmentInfo":431,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":432,"conditions":433,"keywords":436,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":47},"100435033","clinical-molecular-and-imaging-biomarkers-in-spinal-and-bulbar-muscular-atrophy-sbma-100435033","NCT04944940","Clinical, Molecular and Imaging Biomarkers in Spinal and Bulbar Muscular Atrophy (SBMA)","An Observational Study to Assess Clinical, Molecular and Imaging Biomarkers in Spinal and Bulbar Muscular Atrophy (SBMA)","* INCLUSION CRITERIA:\n\nSome restrictions are placed on participation in the study because we aim to identify disease biomarkers specific to those with early to intermediate stages of disease who would be potential candidates for future therapeutic studies.\n\nIn order to be eligible to participate in the SBMA cohort, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male, above the age of 18 years\n* Genetically confirmed SBMA\n* Ability of subject to understand and the willingness to sign a written informed consent document\n* Ability of subject to travel to the NIH Clinical Center.\n\nNote: an SBMA patient who meets both of the additional following criteria will be offered an optional whole body MRI at subsequent follow-up visits:\n\n* Spinal bulbar muscular atrophy functional rating of \\\u003C 50 (and \\> 35).\n* On initial whole body MRI, subject has evidence of muscle fat replacement such that the total volume of disease affected muscles (i.e., muscles with at least 10% muscle fat infiltration and no more than 50% muscle fat fraction) is at least:\n\n  * 500ml if only 1 muscle is eligible or\n  * 250ml if more than one muscle meets the criteria\n\nIn order to be eligible to participate in this study in the Healthy Control cohort, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability to travel to the NIH for the duration of the study\n* Male, above the age of 18 years\n* No history of SBMA or other neuromuscular disorder\n* No history of facial palsy\n* Ability of subject to understand and the willingness to sign a written informed consent document\n* Ability of subject to travel to the NIH Clinical Center.\n\nEXCLUSION CRITERIA:\n\nSBMA is a disease that affects males and manifests in adulthood. Thus, woman and children are not included in this study. This study will not include individuals who lack consent capacity.\n\nAn SBMA patient who meets any of the following criteria will be excluded from participation in this study:\n\n* Contraindications to MRI such as a contraindicated non-removable metal device (i.e., pacemaker, defibrillator, insulin pump, metal clips, non-removable jewelry) or claustrophobia.\n* Non ambulatory\n* Use of androgen reducing agents within the past two years\n\nNote: An SBMA patient who meets any of the following criteria will be excluded from the lumbar puncture procedure:\n\n* PT\u002FPTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)\n* INR greater than or equal to 1.5, thrombocytopenia (\\\u003C70,000), or abnormal bleeding time or platelet dysfunction\n* History of a bleeding disorder\n* Use of anticoagulants\n\nNote: An SBMA patient who meets any of the following criteria will be excluded from the muscle biopsy procedure:\n\n* Advanced wasting of tibialis anterior that precludes needle muscle biopsy (in order to ensure that a sample taken would be of muscle and not just fat and fascia)\n* Use of aspirin or non-steroidal anti-inflammatory agents 3 days prior to the procedure\n\nNote: An SBMA patient who meets any of the following criteria will be excluded from the whole body MRI:\n\n* Patient has a history of prior treatment with androgen reducing agents including LHRH agonists or antagonists, androgen receptor antagonists and selective androgen receptor modifiers.\n* Patient is unable to complete the study assessments of QMT or timed walk tests.\n* Patient anticipates making major lifestyle changes during the observation period relating to diet and exercise.\n\nA Healthy Control participant who meets any of the following criteria will be excluded from the study:\n\n* PT\u002FPTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)\n* INR greater than or equal to 1.5, thrombocytopenia (\\\u003C70,000), or abnormal bleeding time or platelet dysfunction\n* History of a bleeding disorder\n* Use of anticoagulants","MALE",{"count":383,"type":22},"Background:\n\nSBMA is an inherited chronic disease. It affects males in mid to late adulthood. It causes slowly progressive weakness of muscles and hand tremors. Researchers want to learn more about the effects of SBMA.\n\nObjective:\n\nTo identify measurements that change over time in SBMA, including tests of muscle strength and function, as well as measurements of muscle and fat size.\n\nEligibility:\n\nMen over the age of 18 both with and without a history of SBMA.\n\nDesign:\n\nParticipants will have a medical history, physical exam, and blood and urine tests. They will have neuromuscular ultrasound. They will have a lumbar puncture to obtain spinal fluid. For this, a needle will be inserted into the spinal canal in the lower back.\n\nParticipants will have muscle strength and function tests. These tests may include pushing, pulling, rising from a chair and sitting back down, and\u002For walking. During these tests, they may wear an accelerometer (activity tracker) on their wrist.\n\nParticipants will get an activity tracker to wear on their wrist for 10 days at home every 3 months.\n\nParticipants with SBMA will also have lower limb magnetic resonance imaging (MRI) and optional whole-body MRI. They will have lung function tests. They will have speech and swallow tests. They will complete questionnaires. They may have optional body scans to measure bone density and lean body mass. They may have optional muscle biopsies. For biopsies, a needle will be used to take a small piece of muscle from the leg.\n\nParticipants with SBMA will have 5 study visits over 2 years (every 6 months). Participants without SBMA will have 1 study visit.",[434,435,283],"Spinal and Bulbar Muscular Atrophy","Kennedys Disease",[283,434,437,438,439,171],"Kennedys disease","Androgen Receptor","Natural History Study",{"date":393,"type":39},{"date":442,"type":39},"2021-10-25",{"date":444,"type":22},"2027-02-28",{"name":45,"class":46},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":458,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":47},"100337818","feasibility-of-endosphenoidal-coil-placement-for-imaging-of-the-sella-during-transsphenoidal-surgery-100337818","NCT03678389","Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery","* INCLUSION CRITIERIA:\n\nAdult subjects (more than 18 years of age) will be included in this study if they:\n\n1. Have a known or suspected tumor of the pituitary gland that requires surgical resection through a transsphenoidal approach. There is no size restriction. Invasion of surrounding anatomical structures by the pituitary tumor will not be ground for screen failure\u002Fwithdrawal from study.\n2. Are enrolled in 03-N-0164, Evaluation and Treatment of Neurosurgical Disorders. If not enrolled, subjects will not be able to be included in the study as clinical and research procedures are done under the 03-N-0164 protocol.\n3. Are able to provide written consent.\n4. NIH employees are included in the study.\n\nEXCLUSION CRITIERIA:\n\nSubjects will be excluded from this study if they:\n\n1. Are unable to fit the intra-operative MRI table due to size or weight restrictions i.e morbid obesity. Patients will be anaesthetized and therefore claustrophobia will not be ground for screen failure\u002Fwithdrawal from study.\n2. Have an absolute contraindication to MRI imaging or MRI contrast agent according to Rad\\&IS screening including devices or conditions.\n3. Have a variant anatomy which may, in the judgment of the operating neurosurgeon, add unacceptable risk to the placement of the endosphenoidal coil (e.g. small size of facial bones and nasal passages, unaerated sphenoid sinus etc.).\n4. Are pregnant or nursing.\n5. Patients older than 85 years of age. Cushing disease is rare in the older population.","85 Years",{"count":383,"type":22},[110],"Tumors of the pituitary gland comprise up to 20% of all brain tumors. The central location and the small size of the pituitary gland make the management of tumors particularly challenging. Transsphenoidal surgery (TSS) to resect pituitary tumors is highly successful at achieving complete cure for functional pituitary adenomas. It is most successful when such adenomas can be localized by preoperative MRI of the pituitary. However, in some instances, small functional tumors cannot be visualized. In the case of Cushing s disease (CD), such non-visualization may be as high as 50%. The success of transsphenoidal surgery is substantially reduced in patients with negative MRI, as some of the adenomas that cause CD are so small that they are difficult to find during surgical exploration of the pituitary. Surgical success is also diminished when tumors invade the walls of the cavernous sinus. MRI of the pituitary lacks imaging resolution to detect such invasion and so the surgeon cannot perform a complete resection with surgery based on the preoperative MRI.\n\nSignal to noise ratio (SNR) is the primary constraint on achieving high quality high resolution MRI images. SNR can be improved by longer scan times or by increasing the field strength of the MRI magnet. SNR is proportional to the square of imaging time, however, long imaging times are not clinically feasible. SNR is linearly proportional to field strength, however, replacing MRI magnets is cost prohibitive.\n\nAnother strong determinant of SNR is the proximity of the MRI receiver coil to the tissue being imaged. Placement of a coil in close proximity to the structure of interest dramatically increases SNR, often as much as 10-fold. Clinically this is routinely put into practice for superficial body parts, such as the temporomandibular joints, in which small coils are placed directly over the joints to achieve rapid high-resolution imaging. For deep structures, the use of superficial coils is of no benefit. This has led to the development of endocavitary coils, such as the endorectal coil used to image the prostate gland. Such coils are now in routine clinical use here at the NIH and elsewhere.\n\nDuring routine TSS, the surgical approach to the pituitary provides a route for placement of imaging tools, such as handheld ultrasound and Doppler probes in close proximity to the gland. Extending this model to MRI imaging, we realized that an endocavitary surface coil within the sphenoid sinus will allow for a marked improvement in SNR for imaging the sella. To this end, we have developed an endosphenoidal coil (ESC), demonstrated its MRI safety, and performed preliminary studies in cadaver heads to determine that the ESC can be placed through the transsphenoidal approach. Placement of ESC needs no modification in the surgical TSS approach to the pituitary gland. The goal of this protocol is to examine the safety and feasibility of ESC placement and imaging during TSS.",[457],"Pituitary Neoplasm",[265,459,460,461],"pituitary surgery","Transsphenoidal Surgery","Pituitary Tumors",{"date":393,"type":39},{"date":464,"type":39},"2019-05-09",{"date":466,"type":22},"2028-12-01",{"name":45,"class":46},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":474,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":476,"conditions":477,"keywords":481,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":47},"100303052","investigating-complex-neurodegenerative-disorders-related-to-amyotrophic-lateral-sclerosis-and-frontotemporal-dementia-100303052","NCT03225144","Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia","* INCLUSION CRITERIA:\n\nPatients will be included if they\n\n* Are age 18 or older\n* Have been given a diagnosis by a neurologist of frontotemporal dementia, primary progressive aphasia, semantic dementia, motor neuron disorder, amyotrophic lateral sclerosis, progressive bulbar palsy, corticobasal syndrome, Huntington disease or other related adult-onset neurodegenerative disorder OR\n* Carry a mutation in a gene that causes familial ALS or FTD\n\nEXCLUSION CRITERIA:\n\nPatients will be excluded if they\n\n* Have other major neurological or medical diseases that may cause progressive weakness or cognitive dysfunction, such as structural brain or spinal cord disease, metabolic diseases, paraneoplastic syndromes, infectious diseases, peripheral neuropathy or radiculopathy or other significant neurological abnormalities.\n* Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe\n* Require daytime ventilator support at the time of study entry\n* Are unable to travel to NIH\n* Patients with pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, or shrapnel fragments, metal fragments in the eye) will not be excluded but will not undergo magnetic resonance imaging.\n* Patients with tattoos above the neck or permanent make up will be excluded from undergoing 7T MRI.",{"count":475,"type":22},360,"Background:\n\nNeurodegenerative disorders can lead to problems in movement or memory. Some can cause abnormal proteins to build up in brain cells. Researchers want to understand whether these diseases have related causes or risk factors.\n\nObjective:\n\nTo test people with movement or thinking and memory problems to see if they are eligible for research studies.\n\nEligibility:\n\nPeople ages 18 and older with a neurodegenerative disorder associated with accumulation of TDP-43 or Tau proteins\n\nDesign:\n\nParticipants will have a screening visit. This may take place over 2-3 days. Tests include:\n\nMedical history\n\nPhysical exam\n\nQuestions about behavior and mood\n\nTests of memory, attention, concentration, and thinking\n\nMovement measurement. The speed at which participants can stand up from a chair, tap their finger and foot, and walk a short distance will be measured. Some movements will be videotaped. They will be videotaped while they speak and read a paragraph.\n\nBlood tests. This might include genetic testing.\n\nLung and breathing tests\n\nMRI. They will lie on a table that slides into a cylinder that takes pictures of the body. Some participants will get a dye through IV.\n\nElectromyography. A thin needle will be inserted into the muscles to measure electrical signals.\n\nNerve tests. Small electrodes on the skin record muscle and nerve activity.\n\nA small piece of skin may be removed.\n\nA skin or blood sample may be taken to create stem cells.\n\nOptional lumbar puncture. A needle will be inserted into the space between the bones of the back to collect fluid.\n\nIf participants are not eligible for current studies, they may be contacted in the future.",[478,479,480],"Frontotemporal Dementia","Amyotrophic Lateral Sclerosis","Progressive Supranuclear Palsy",[482,480,283,478,483,171],"TDP-43","Corticobasal Syndrome",{"date":393,"type":39},{"date":486,"type":39},"2017-10-11",{"date":488,"type":22},"2027-10-30",{"name":45,"class":46},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":184,"sex":17,"minAge":18,"maxAge":497,"enrollmentInfo":498,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":500,"conditions":501,"keywords":502,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":47},"100257353","functional-magnetic-resonance-imaging-sleep-study-with-auditory-stimuli-100257353","NCT02629107","Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli","An All-Night Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli","* INCLUSION CRITERIA:\n\n  1. able to give informed consent;\n  2. in good general heath;\n  3. between the ages of 18 and 34 years;\n  4. able to sleep on your back for several hours (with breaks).\n\nEXCLUSION CRITERIA:\n\n1. have a medical condition like diabetes or uncontrolled hypertension;\n2. have a psychiatric or neurologic condition like depression or stroke;\n3. have ever had a seizure;\n4. have a sleep disorder like insomnia or sleep apnea;\n5. work night shifts;\n6. have metal in your body such as pacemakers, metal prostheses, or aneurysm clips that would make MRI scanning unsafe;\n7. are pregnant or nursing;\n8. drink too much caffeine (6 or more cups of coffee per day or 10 or more cups of caffeinated soda per day);\n9. use too much alcohol (15 or more alcoholic beverages per week for men and 8 or more alcoholic beverages per week for women);\n10. use too much nicotine (nicotine use within 30 minutes of waking);\n11. are afraid of enclosed spaces;\n12. have known hearing problems;\n13. regularly use a prescription or over-the-counter drug to help you sleep or stay awake;\n14. are an employee, contractor, or volunteer of the Laboratory of Functional and Molecular Imaging in the National Institute of Neurological Disorders and Stroke.","34 Years",{"count":499,"type":22},2378,"Background:\n\nAn electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that the louder the sound needed to wake a person, the deeper the person s sleep. Researchers are using functional magnetic resonance imaging (fMRI) to study people during sleep so they can view brain activity in 3D. But they still need to correlate fMRI with sound thresholds, like the EEG.\n\nObjective:\n\nTo measure brain activity during sleep using fMRI and EEG.\n\nEligibility:\n\nHealthy people ages 18 34 who can sleep on their back for several hours.\n\nDesign:\n\nParticipants will be screened online about their sleep and general health.\n\nAt a screening visit, participants will have:\n\nPhysical exam\n\nHearing exam\n\nMRI scan. A strong magnetic field and radio waves take pictures of the brain. Participants will lie down on a bed that slides into the scanner, which is shaped like a cylinder.\n\nParticipants will wear an actigraph on their wrist that records their motor activity.\n\nParticipants will follow a 2-week routine. This includes regular in-to-bed and out-of-bed times and limits on alcohol, caffeine, and nicotine.\n\nDuring the overnight visits, participants will have:\n\nFemale subjects will have a urine pregnancy test.\n\nfMRI. A coil will be placed over the head. Participants will do tasks shown on a computer screen inside the scanner.\n\nEEG. Small electrodes on the scalp will record brain waves while sleeping or doing a task in the scanner.\n\nParticipants will be asked to try to sleep while researchers collect fMRI and EEG data. Participants eyes will be monitored with a video camera. Headphones will deliver sounds to wake them up throughout the night.\n\n...",[189],[242,503,504,171],"Functional Magnetic Resonance Imaging (fMRI)","Electroencephalogram (EEG)",{"date":393,"type":39},{"date":507,"type":39},"2016-01-14",{"date":509,"type":22},"2045-12-31",{"name":45,"class":46},{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":184,"sex":17,"minAge":517,"maxAge":278,"enrollmentInfo":518,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":47},"100217448","noninvasive-pre-surgical-evaluation-of-patients-with-focal-epilepsy-and-establishment-of-a-normative-imaging-database-100217448","NCT02107989","Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database","* INCLUSION CRITERIA FOR PATIENTS:\n* Age 8 and older\n* Evaluated or under evaluation for epilepsy surgery under protocol 18-N-0066,11-N-0051 or 16-N-0041\n* Documentation of focal epilepsy based on MRI, EEG and\u002For ictal semiology\n* Ability to give informed consent, have or be able to assign a legally authorized representative able to give consent (for adults without consent capacity), or parent\u002Fguardian able to provide informed consent (for a child).\n\nINCLUSION CRITERIA FOR PATIENTS SOLELY CONTRIBUTING DATA:\n\n* Had epilepsy surgery with presurgical evaluation under 18-N-0066\n* Age 8 and up at the time of epilepsy surgery evaluation\n* Had a preoperative structural brain MRI of the type used in this protocol\n\nINCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n\n* Age 8 and older\n* Ability to give informed consent or have a parent\u002Fguardian able to provide informed consent if a child.\n* Ability to cooperate with MRI scanning without anesthesia\n\nEXCLUSION CRITERIA FOR PATIENTS:\n\n* Contraindications to MRI or MEG studies (such as pacemakers, cochlear implants, shrapnel, permanent eyeliner)\n* Claustrophobia or anxiety disorders exacerbated by the MRI scanner\n* Pregnancy. All females of childbearing potential must have a negative pregnancy test prior to MRI scanning\n\nEXCLUSION CRITERIA FOR PATIENTS SOLELY CONTRIBUTING DATA:\n\n-Not able or willing to give consent or do not have an appropriate surrogate who can provide consent\n\nEXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n\n* Contraindications to MRI or MEG studies (such as pacemakers, cochlear implants, shrapnel, permanent eyeliner)\n* Claustrophobia or anxiety disorders exacerbated by the MRI scanner\n* Significant medical conditions that may affect the central nervous system, such as psychiatric disorders (such as mood disorders, psychotic disorders, substance abuse or dependence), significant neurologic disorders (such as brain injury, neurodegenerative disorders, multiple sclerosis, stroke, movement disorders, epilepsy), or active systemic disease that may affect the central nervous system (such as uncontrolled hypertension, autoimmune disorders or other inflammatory disorders, neoplastic disease)\n* Use of centrally acting medications in the past 6 weeks, such as benzodiazepines, barbiturates, antidepressants, beta-blockers, and drugs for treating epilepsy or migraine\n* Pregnancy. All females of childbearing potential must have a negative pregnancy test prior to MRI scanning","8 Years",{"count":519,"type":22},700,"Objectives:\n\nThe overall study objective is to compare the sensitivities and specificities of morphometric analysis techniques using structural MRI images based on pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy. To carry out these analyses, we aim to establish an age-stratified normative imaging database using healthy volunteers. Additional objectives are to identify abnormal networks in these patients using resting state fMRI\u002FEEG and MEG\u002FEEG, and to use language and memory fMRI tasks to examine the effects of epileptogenic zones and surgery on cognitive function and the networks associated with these functions.\n\nStudy population:\n\n300 adults and children (age 8 and older) with uncontrolled focal epilepsy, and 200 age-stratified healthy volunteers.\n\nDesign: A retrospective and prospective natural history study. Research procedures for patients in this study include neuropsychological testing and 1-4 MRI sessions during presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing approximately 12 months post-operatively. Research testing (such as research neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical testing whenever possible, likely reducing the number of required visits. Patients will also have optional MEG and 7T structural imaging. Data will also be obtained from patients who have already undergone epilepsy surgery if they had procedures as outlined in the protocol and are willing to share the data. Healthy volunteers will receive a subset of the pre-operative procedures for patients, requiring at least 3 visits. In order to ensure adequate data acquisition, subjects may be re-scanned up to three times for the portions of the study in which they participated, possibly requiring additional visits.\n\nOutcome measures:\n\nThe main outcomes will be establishment of normative values for morphometric analysis methods in age-stratified normal controls, and comparison of the sensitivity and specificity of these measures to pre- and postsurgical localization of the epileptogenic zone. Secondary outcome measures will include determination of the sensitivity and specificity of source localization using MEG\u002FEEG and resting state fMRI\u002FEEG, and to evaluate changes in activation during rest, as well as language and memory fMRI tasks in patients pre- and postsurgically, to examine the effects of epileptogenic zones and surgery on cognitive function and the networks underlying these functions.",[264],[264,191,523,524,171],"fMRI","MEG",{"date":393,"type":39},{"date":527,"type":39},"2014-03-11",{"date":529,"type":22},"2028-03-30",{"name":45,"class":46},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":47},"100177251","deep-brain-stimulation-surgery-for-movement-disorders-100177251","NCT01581580","Deep Brain Stimulation Surgery for Movement Disorders","* INCLUSION CRITERIA:\n\nTo be eligible for entry into the study, candidates must meet all the following criteria:\n\nBe 18 years of age or older.\n\nAble to provide informed consent.\n\nHave a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy:\n\n* idiopathic PD not adequately controlled with medication or\n* primary dystonia that is medically refractory, or\n* ET that is not adequately controlled by medications or constitutes a significant functional disability.\n\nEXCLUSION CRITERIA:\n\nCandidates will be excluded if they:\n\nAre unable or unwilling to give informed consent to the research procedures.",{"count":186,"type":22},[110],"Background:\n\n\\- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery.\n\nObjectives:\n\n* To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.\n* To obtain information on brain and nerve cell function during DBS surgery.\n\nEligibility:\n\n\\- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia.\n\nDesign:\n\n* Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests.\n* During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier.\n* After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings.\n* Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.",[113,117,541],"Dystonia",[113,115,543,544,541,545,117],"Neurophysiology","Movement Disorder","Parkinson Disease",{"date":393,"type":39},{"date":548,"type":39},"2011-08-17",{"date":550,"type":22},"2029-12-01",{"name":45,"class":46},{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":184,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":558,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":47},"100560463","cross-sectional-evaluation-of-persistence-of-sars-cov-2-remnants-after-recovery-from-acute-infection-100560463","NCT06577467","Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection","* INCLUSION CRITERIA:\n\nRecovered Volunteers (RV): Six healthy persons who have recovered from an acute SARS-CoV-2 infection.\n\nInclusion criteria:\n\n* Participants 18 and older\n* Ability to provide informed consent\n* Completed participation in Phase B of Protocol 000089\n* Met 000089 Inclusion criteria for Mild to Moderate COVID-19 without PASC symptoms:\n\n  * Licensed Independent Practitioner documentation of a stable state of general well-health and physical function prior to contracting SARS-CoV-2. This may include medical records, correspondence letters, or information gathered from telephone calls with study personnel.\n  * A self-reported illness narrative of recovery to prior health after a SARS\u002FCoV2 infection.\n  * Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive anti-SARS nucleocapsid antibody test.\n  * Meets WHO Clinical Progression Scale of 2 - 6:\n\n    2: Ambulatory; symptomatic, independent\n\n    3: Ambulatory; symptomatic, assistance needed\n\n    4: Hospitalized; no oxygen therapy\n\n    5: Hospitalized; oxygen by mask or nasal prongs\n\n    6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen\n  * Functional Criteria: No substantial symptom severity as determined using SF-36v2: score of \\>=85 physical function subscale, and \\>=85 on role physical subscale, and \\>=85 on social function subscale.\n* Determined to be a Healthy Comparator by the 000089 Case Adjudication Committee\n* Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and\u002For testing. Testing may be repeated with each admission. Participants may be rescreened 6 weeks after acute infection has resolved.\n\nNeurologic Post-Acute Sequelae of COVID-19 Participants (Neuro-PASC):\n\nSix persons with ongoing neurological complaints following an acute SARS-CoV-2 infection.\n\nInclusion criteria:\n\n* Participants 18 and older\n* Ability to provide informed consent\n* Completed participation in Phase B of Protocol 000089\n* Met 000089 Inclusion criteria for Mild to Moderate COVID-19 with PASC symptoms:\n\n  * Licensed Independent Practitioner documentation of a stable state of general well-health and physical function prior to contracting SARS-CoV-2. This may include medical records, correspondence letters, or information gathered from telephone calls with study personnel.\n  * A self-reported illness narrative of the development of persistent PASC symptoms after recovering from a SARS-CoV-2 infection. These include symptoms such as fatigue, cognitive difficulties, orthostatic intolerance, unrefreshing sleep, neuropathic pain, mood change, and post-exertional malaise.\n  * Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive anti-SARS nucleocapsid antibody test .\n  * Meets WHO Clinical Progression Scale of 2 - 6:\n\n    2: Ambulatory; symptomatic, independent\n\n    3: Ambulatory; symptomatic, assistance needed\n\n    4: Hospitalized; no oxygen therapy\n\n    5: Hospitalized; oxygen by mask or nasal prongs\n\n    6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen\n  * Functional Criteria: Substantial symptom severity as determined using SF-36v2: score of \\\u003C= 70 physical function subscale, or \\\u003C=50 on role physical subscale, or \\\u003C=75 on social function subscale.\n* Determined to have Post-Acute Sequelae of COVID-19 by the 000089 Case Adjudication Committee\n* Primary PASC complaint is neurologic including:\n\n  * Neuropathic sensations\n  * Cognitive complaints\n  * Postural (Orthostatic) complaints\n  * Motor complaints\n* Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and\u002For testing. Testing may be repeated with each admission. Participants may be rescreened 6 weeks after acute infection has resolved.\n\nEXCLUSION CRITERIA:\n\n* Current suicidal ideation\n* Women who are pregnant, breastfeeding, or are within one-year post-partum.\n* Current or previous malignancy. A history of malignancy that has fully resolved with surgical resection only (e.g. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.\n* Current systemic immunologic disorders (e.g. Type 1 diabetes, rheumatoid arthritis). Local immunological disorder (e.g. atopic dermatitis, stable autoimmune thyroid disease) and allergic disorders will be allowed.\n* Current or previous long-term immune suppressive therapy. Systemic steroid use, even short-term, must not have been used within the month prior to enrollment.\n* Long term use of anticoagulant or antiplatelet medications.\n* Active participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.\n* Not willing to allow for research data and samples to be shared broadly with other researchers.\n* Employees of NIH.\n* Symptom severity that makes it impossible for the volunteer to travel to NIH for an extended inpatient evaluation\n* Use of medications with a high-risk for withdrawal-related complications (i.e. long-acting opiates or benzodiazepines).\n* Unwillingness to co-enroll in protocol 17-I-0122: NIAID Centralized Sequencing Protocol.",{"count":559,"type":22},12,"Background:\n\nSARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have symptoms that last long after the active infection ends. This is called \"long COVID.\" Sometimes, long COVID can affect the nerves and cause problems with sleep, thinking, the senses, and movement. Researchers want to find out whether people with long COVID have retained inactive remnants of SARS-CoV-2 in their bodies.\n\nObjective:\n\nTo collect tissue samples to see if people with long COVID have remnants of SARS-CoV-2 in their bodies.\n\nEligibility:\n\nPeople 18 years or older who have recovered from COVID-19, both with and without neurologic symptoms.\n\nDesign:\n\nParticipants will have 2 to 6 inpatient or outpatient visits over 4 months. Each visit will last 4 to 5 days.\n\nParticipants will be screened to make sure it is safe to collect tissue samples from their body. They will have a physical and dental exam. They will have imaging scans and a test of their heart function. They will complete questionnaires about their health. They will give blood, urine, saliva, and stool samples. Their sense of taste and smell will be tested.\n\nTissue samples will be taken from the digestive tract, lungs, colon, skin, muscle, lymph nodes, nasal passages, and mouth. Participants may be numbed or sedated for some of the procedures.\n\nSwabs will be used to collect cells from inside the mouth and nose.\n\nParticipants will undergo lumbar puncture. A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.\n\nParticipants will have follow-up phone calls after each clinic visit.",[562],"PASC Post Acute Sequelae of COVID-19",[30,33],"2026-08-11",{"date":391,"type":39},{"date":567,"type":39},"2025-03-27",{"date":569,"type":22},"2027-09-01",{"name":45,"class":46},{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":577,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":578,"conditions":579,"keywords":583,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":47},"100442438","data-collection-of-standard-care-of-patients-in-the-emg-section-100442438","NCT05041387","Data Collection of Standard Care of Patients in the EMG Section","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* The patient or the patient's Legally Authorized Representative is capable of informed consent and signs the consent form.\n* Male or female, age 18 and over, no age limit\n* Possible neuromuscular disorder or neurodegenerative disorder.\n\nEXCLUSION CRITERIA:\n\nNo other exclusion criteria for patients",{"count":186,"type":22},"Background:\n\nMost people who are referred to the EMG (Electromyography) Section of the NIH are enrolled into specific active studies. This allows researchers to learn about a range of rare neuromuscular disorders. But study criteria may not give researchers the chance to evaluate a single person or study a common symptom. Therefore, researchers want to assess people with neuromuscular disorders who are not currently enrolled in any NIH studies. They will perform tests on these individuals in the EMG Lab. Then they will create a repository of data that may be used for future research. This will help them learn more about these disorders.\n\nObjective:\n\nTo retain data that is collected as part of participant visits to the NIH.\n\nEligibility:\n\nPeople aged 18 and older who will be visiting the NIH for evaluation of their neuromuscular disorder.\n\nDesign:\n\nParticipants will be screened with a medical record review.\n\nParticipants will have a physical exam. They will be evaluated for their neuromuscular disorder. They may have tests to learn more about how their nerves and muscles work that are called nerve conduction and EMG studies. Their muscles and nerves may be assessed with an ultrasound. Their ability to sweat may be measured. Their heart rate and blood pressure may be taken. Changes to their breathing or changes in their body position may be measured.\n\nParticipant data will be given a unique numerical identifier that can be used if the data is shared. Data will be stored on a server and in a database.\n\nParticipants will have 1-2 visits. Each visit will last less than 4 hours. They may be contacted for a follow-up visit.",[580,581,582],"Neuropathy","Muscle Disorders","Dysautonomia",[584,585,586],"Standard of Care","Screening","NEUROMUSCULAR DISORDERS","2026-08-08",{"date":564,"type":39},{"date":590,"type":39},"2024-06-24",{"date":592,"type":22},"2031-05-01",{"name":45,"class":46},""]