[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amyotrophic-lateral-sclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amyotrophic-lateral-sclerosis":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,126,0,25,[9,52,81,109,136,159,177,206,226,255,277,308,332,358,380,411,435,454,478,499,514,539,555,576,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100329283","investigation-on-the-cortical-communication-corticom-system-100329283",false,"NCT03567213","Investigation on the Cortical Communication (CortiCom) System","CortiCom","Inclusion Criteria:\n\n* Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS)\n* Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment\n* Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), or severe ataxia. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in LIS.\n* 22-70 years\n* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants\n* Ability to communicate reliably, such as through eye movement\n* Willingness and ability to provide informed consent\n* Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study\n* Ability and willingness to travel up to 100 miles to study location up to three days per week for the duration of the study\n* Ability to understand and comply with study session instructions\n* Participant consents to the study and still wishes to participate at the time of the study\n\nExclusion Criteria:\n\n* Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.\n* Suicide attempt or persistent suicidal ideation within the past 12 months.\n* Implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants.\n* History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months\n* Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease\u002Fdisorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)\n* Other chronic, unstable medical conditions that could interfere with subject participation.\n* Presence of pre-surgical findings in anatomical, functional, and\u002For vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team)\n* Prior cranioplasty\n* Inability to undergo MRI or anticipated need for an MRI during the study period\n* Participants with active infections or unexplained fever\n* Participants with other morbid conditions making the implantation of the recording elements unsafe; not limited to: significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe\n* Pregnancy (confirmation through blood test)\n* Nursing an infant, planning to become pregnant, or not using adequate birth control\n* Corrected vision poorer than 20\u002F100\n* HIV or AIDS infection\n* Existing scalp lesions or skin breakdown\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Active cancer within the past year or requires chemotherapy\n* Uncontrolled autonomic dysreflexia within the past 3 months\n* Hydrocephalus with or without an implanted ventricular shunt\n* Participants in whom it is medically contraindicated to stop anti-coagulant medications during surgery","ALL","22 Years","70 Years",{"count":21,"type":22},3,"ESTIMATED","INTERVENTIONAL",[25],"NA","The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.",[28,29,30,31],"Tetraplegia","Locked-in Syndrome","Brainstem Stroke","Amyotrophic Lateral Sclerosis",[28,33,29,34,35,36,37,38],"ALS","Brainstem stroke","Brain Computer Interface","Rehabilitation","Stroke","Hopkins","RECRUITING","2026-08-19",{"date":42,"type":43},"2026-08-21","ACTUAL",{"date":45,"type":43},"2021-12-14",{"date":47,"type":22},"2030-12-31",{"name":49,"class":50},"Johns Hopkins University","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100641756","phase-1-a-study-of-ltx-002-in-adult-participants-with-amyotrophic-lateral-sclerosis-100641756","NCT07660614","A Study of LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis","A First-in-Human, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intrathecally Administered LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis","NeurALS","Inclusion Criteria:\n\n* Diagnosis of ALS per Gold Coast criteria\n* ALS symptom onset less than 36 months prior to Screening\n* Slow vital capacity ≥ 50% of predicted value\n* Body mass index ≥18 and ≤40 kg\u002Fm2\n\nExclusion Criteria:\n\n* Current evidence or history of a clinically significant medical condition that, in the Investigator's judgement, would impact the participant's safety, interpretation of study results, or place the participant at high risk of poor treatment compliance or of not completing the study\n* History of brain or spinal abnormalities on magnetic imaging (MRI) or computed tomography (CT) that might interfere with the lumbar puncture (LP), cerebrospinal fluid (CSF) circulation or safety assessments\n* Prior treatment with antisense oligonucleotide (ASO), small interfering RNA, stem cell therapy, or gene therapy for any indication\n* Tracheostomy\n* HIV, Hepatitis B or C infection (acute or chronic)\n* Presence of implanted shunt (CSF) or vascular device\n* Risk for uncontrolled bleeding\n* Pregnant or breastfeeding","18 Years","75 Years",{"count":63,"type":22},56,[65,66],"PHASE1","PHASE2","This study will examine what happens when patients with amyotrophic lateral sclerosis (ALS) are given an investigational medication (study drug) known as LTX-002. Specifically, the researchers will be looking at safety, tolerability (if someone has any side effects from the drug), pharmacokinetics (what the body does to the study drug) and pharmacodynamics (what the study drug does to the body). The study will also investigate the effect of the drug on indicators of the severity of ALS, such as markers in blood and in the cerebrospinal fluid (the fluid that surrounds the brain and spinal cord, CSF) and on measures of the participant's ability to move, speak, and breathe.",[31],[33],"2026-08-17",{"date":72,"type":43},"2026-08-18",{"date":74,"type":43},"2026-04-29",{"date":76,"type":22},"2031-06",{"name":78,"class":79},"Leal Therapeutics, Inc","INDUSTRY",5,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":51},"100610183","early-phase-1-effect-of-terazosin-on-atp-levels-in-people-with-amyotrophic-lateral-sclerosis-100610183","NCT07224269","Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis","A Pilot Study of the Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis","TZ-ALS","INCLUSION CRITERIA\n\n* Ages 18 - 80 years old\n* Diagnosed with ALS based on Gold Coast Criteria\n* ALS symptom onset within 36 months at enrollment\n* Slow vital capacity (SVC) greater than or equal to 65%\n* Riluzole use-Never taken or taking a stable dose for at least 4 weeks prior to screening visit or will refrain from starting for the duration of the study\n* Edaravone use-Never taken or completed at least one cycle (typically 14 days) prior to screening visit or will refrain from starting for the duration of the study\n* Must have the ability to swallow pills at the time of the screening visit, and in the principle investigator's opinion, have the ability to swallow pills for the duration of the study\n* Willing to use highly effective contraception for the duration of the trial treatment and for a duration of 80 days after the last dose.\n\nEXCLUSION CRITERIA\n\n* Orthostatic hypotension at screening is defined as decrease in BP \\> 20 mmHg systolic or \\> 10 mmHg diastolic and HR increase \\\u003C20 bpm on transition from supine to sitting or from sitting to standing\n* Known allergy or previous adverse reaction to terazosin or related compound\n* Current use of terazosin or concurrent use of doxazosin, alfuzosin, prazosin, or tamsulosin at the time of screening visit or within the 3 months prior to baseline visit\n* Pregnancy or breastfeeding women\n* Taking therapeutic anticoagulant medication (i.e. warfarin, DOAC's, full dose Lovenox or heparin)\n* Liver function blood tests (ALT or AST) more than twice the upper limit of normal\n* Hemoglobin \\\u003C 11.0 g\u002FdL\n* Traumatic brain injury or post-traumatic stress disorder\n* Presence of a confounding acute or unstable medical, psychiatric, or orthopedic condition\n* Noncompliant or sporadic use of medications that modulate the central nervous system\n* Uncontrolled major depression or bipolar affective disorder, or other mental health disorders that are, in the opinion of the PI, sufficiently severe to increase risk of experiencing an Adverse Drug Reaction (ADR)\n* Current suicidal ideation as measured by question 2 of the Columbia-Suicide Severity Rating Scale (C-SSRS)\n* Participants with insufficient decisional capacity to provide written informed consent determined by the primary investigator.\n* Noncompliant or sporadic use of antihypertensive medications\n* Unable to lie supine and still for 60 minutes for the duration of the study\n* Currently taking part in another clinical trial with an investigational medicinal product or having taken part in one in the three months prior to screening visit\n* Current diagnosis of diabetes (type 1 or type 2) or healthcare professional-recommended treatment (medication, exercise or diet) of diabetes mellitus\n* Screening visit glucose \\>140 mg\u002Fdl","80 Years",{"count":91,"type":22},20,[93],"EARLY_PHASE1","This will be a single center, randomized, double-blind, placebo-controlled pilot study to assess the safety and tolerability of terazosin (TZ) at a dose of 5 milligrams (mg) per os (PO) daily for patients with amyotrophic lateral sclerosis (ALS). The primary outcome of this study is to determine whether TZ increases adenosine triphosphate (ATP) levels in ALS. The investigators will measure adverse outcomes, safety, and tolerability of taking TZ. Procedures include blood draws, spirometry, fluorodeoxyglucose-positron emission tomography (FDG-PET) scans, questionnaires, and physical examinations. TZ will be titrated up to 5 mg PO daily. This is a pilot study and is not powered to assess efficacy of this medication. The investigators' hope is that this study will guide future studies of this (and similar) medications for the disease modification of ALS. This study also aims to learn more about how patients produce and use energy and if TZ can help to reverse energy deficits that appear in ALS.",[31,96],"Adenosine Triphosphate Activities",[98,99,100],"amyotrophic lateral sclerosis","terazosin","clinical trial","2026-08-13",{"date":70,"type":43},{"date":104,"type":43},"2026-08-12",{"date":106,"type":22},"2027-10-31",{"name":108,"class":50},"University of Iowa",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":51},"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.","110 Years",{"count":117,"type":22},360,"OBSERVATIONAL","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.",[121,31,122],"Frontotemporal Dementia","Progressive Supranuclear Palsy",[124,122,125,121,126,127],"TDP-43","Motor Neuron Disease","Corticobasal Syndrome","Natural History",{"date":101,"type":43},{"date":130,"type":43},"2017-10-11",{"date":132,"type":22},"2027-10-30",{"name":134,"class":135},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":89,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":63},"100617698","phase-3-pridopidine-phase-3-study-to-evaluate-efficacy-and-safety-in-als-100617698","NCT07322003","Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","PREVAiLS","Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and\u002For unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and\u002For to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.",{"count":145,"type":22},500,[147],"PHASE3","The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests",[31],"2026-08-09",{"date":152,"type":43},"2026-08-11",{"date":154,"type":43},"2026-02-01",{"date":156,"type":22},"2029-03",{"name":158,"class":79},"Prilenia",{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":51},"100566555","early-phase-1-effects-of-psilocybin-in-patients-with-amyotrophic-lateral-sclerosis-100566555","NCT06656702","Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n1. Patients aged 18 years and older.\n2. Patients must fulfill ALS El Escorial criteria for possible, probable, laboratory supported probable or definite ALS.\n3. Patients with a pulmonary forced vital capacity (FVC) \\>50%. The investigators have chosen this measure of function to account for respiratory decompensation during the 6-month longitudinal portion of the study.\n4. Patients with ability to swallow tablets by mouth. Participants may have a feeding tube, but must be able to swallow by mouth and cannot use the feeding tube to administer the psilocybin tablet.\n5. Clinically significant depressive symptoms as evidenced by an Assessment of Depression Inventory (ADI)-12 score \\>22.\n\nExclusion Criteria:\n\n1. Patients with severe speech impairments, including those who are nonverbal, require assisted speech devices, and those who can only communicate by writing or texting.\n2. Patients who are unable to consent for themselves.\n3. Patients with tracheostomy or continuous continuous positive airway pressure (CPAP) or BiPAP.\n4. Known clinical evidence of frontotemporal dementia.\n5. Cardiovascular conditions: corrected QT interval (QTc) \\>450 msec, uncontrolled hypertension (i.e., systolic blood pressure (SBP)\\> 139 mm Hg, diastolic blood pressure (DBP)\\> 89 mm Hg), resting heart rate (HR)\\> 90 beats per minute, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), transient ischemic attack (TIA) in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication).\n6. Epilepsy with history of seizures\n7. Renal disease (creatinine clearance \\\u003C40 ml\u002Fmin using the Cockraft and Gault equation)\n8. Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n9. Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control (i.e., intrauterine systems\u002Fdevices, hormonal methods including implant, shot, patch, ring, or oral contraceptive, condom, diaphragm, sterilization, and abstinence).\n10. Currently taking medications that interact with psilocybin on a regular (e.g., daily) basis: Atypical antidepressants, such as mirtazapine (Remeron), trazodone (Oleptro), vortioxetine (Brintellix), and vilazodone (Viibryd); Tricyclic antidepressants, such as amitriptyline, imipramine (Tofranil), nortriptyline (Pamelor), desipramine (Norpramin), doxepin, trimipramine (Surmontil), and protriptyline (Vivactil); and Monoamine oxidase inhibitors (MAOIs), such as Selegiline (Emsam), tranylcypromine (Parnate), phenelzine (Nardil) and isocarboxazid (Marplan).\n11. Currently taking Nuedexta (dextromethorphan\u002Fquinidine combination), efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag.\n12. Current or history of meeting Diagnostic and Statistical Manual (DSM)-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder\n13. Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I disorder.",{"count":166,"type":22},24,[93],"This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population.",[31],"2026-08-07",{"date":152,"type":43},{"date":173,"type":43},"2025-04-09",{"date":175,"type":22},"2027-07-01",{"name":49,"class":50},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":89,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":51},"100636884","therapeutic-approach-of-repeated-transient-blood-brain-barrier-opening-in-amyotrophic-lateral-sclerosis-100636884","NCT07571486","Therapeutic Approach of Repeated Transient Blood-brain Barrier Opening in Amyotrophic Lateral Sclerosis.","Therapeutic Approach of Repeated Transient Blood-brain Barrier Opening in Amyotrophic Lateral Sclerosis. A One-arm, Single-center, Proof-of-concept Study (Son-ALS)","Son-ALS","Inclusion Criteria:\n\n1. Age 18-80 years,\n2. Able and willing to give signed and informed consent\n3. Confirmed diagnosis of ALS using the Gold Coast criteria with involvement of both upper and lower motor neurons in at least one body region, i.e. patients classified as \"definite\", \"probable\", \"probable laboratory supported\" or \"possible\" ALS using the El Escorial categories (patients with only lower motor neuron involvement will not be included)\n4. Disease duration \\\u003C= 36 months,\n5. Mild functional impairment (ALSFRS-R ≥30),\n6. Change in ALSFRS-R score between 0.35 points and 1.1 points per month (both inclusive) in the period from onset of first symptoms to the Screening visit,\n7. Slow Vital capacity \\>= 70% of normal,\n8. If taking riluzole, patient on stable dose for over 30 days prior to study entry,\n9. Able and willing to follow trial procedures including site travels and visit requirements\n\nExclusion Criteria:\n\n1. Patients with an uncontrolled intercurrent illness or any pre-existing comorbidities that in the Investigator's opinion may prevent the implantation of the device or may impair the ability of the patient to receive treatment with SonoCloud or may be cofounding for evaluation of the clinical trial\n2. Cardiac pacemaker (contraindication to MRI)\n3. Allergy to any drug used in the study (Gadolinium, Xylocain, Cloxacilline, EMLA, echographic contrast agent microbubbles: SonoVue®)\n4. Severe or instable chronic or acute disease or any life-threatening condition\n5. Other significant neurological or psychiatric disease in addition to ALS, including history of uncontrolled seizures\n6. Treatment with edaravone, tofersen or with another investigational drug or biological agent within 1 month or 5 half-lives of study agent, whichever is longer, before screening\n7. Invasive or non-invasive mechanical ventilation use\n8. Gastrostomy or nasogastric tube use\n9. Known right-to-left shunts,\n10. Known severe pulmonary hypertension (pulmonary artery pressure \\>90 mmHg), uncontrolled systemic hypertension\n11. Known respiratory distress syndrome\n12. Women of child-bearing potential or sexually active man, without contraception\n13. Pregnant or breast-feeding woman\n14. History or positive test result at screening for HIV, current hepatitis C infection (defined as positive HCV antibody and detectable HCV RNA) or current hepatitis B infection (defined as positive for HBsAg and\u002For total anti-HBc). Participants with positive HCV antibody and undetectable HCV RNA are eligible to participate in the study. Participants with immunity to hepatitis B from previous natural infection (defined as negative HbsAg, positive anti-HBc, and positive anti-HBs) or vaccination (defined as negative HbsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study.\n15. Patient not affiliated or beneficiary of a social security category",{"count":186,"type":22},23,[65,66],"This is proof-of-concept, single-arm, single-center study to assess the safety and explore the efficacy of repeated US transient disruptions of the blood-brain barrier (BBB) in Amyotrophic Lateral Sclerosis (ALS).\n\nPhase 1:\n\nThe primary objective is to assess the safety of ultrasound induced BBB opening in the upper motor neuron area and adjacent supplementary motor area in adult patients with ALS, as assessed by adverse events frequency and severity during study (incidence of AE summarized by system organ class and\u002For preferred term and severity) based on the Common Terminology Criteria for Adverse Events, version 5.0 A run-in period of 12 weeks between inclusion and baseline will take place for each patient in order to evaluate precisely disease progression rate, disease severity and to collect concomitant medication. After this run-in period, the patient will be implanted with the SC4 device (baseline visit). The first sonication session will be performed two weeks after implantation. A total of 9 sonications, with no concomitant drug administration, will be performed over a period of 24 weeks.\n\nPhase 2a:\n\nBased on the safety outcome of the Phase 1, an expansion cohort will open to assess the first signal of efficacy of the US transient disruptions of the BBB in ALS. The primary objective will be to assess the first signal of efficacy of the procedure on disease progression over 26 weeks evaluated by the change from baseline to week 26 of neurofilament light (NfL) levels in blood.The Phase 2a will continuously include 11 additional patients. Patients will be treated according to the same schedule as in phase 1",[31,190],"Charcot Disease",[192,193,194,195,196],"Neuroinflammation","Motor neuron","Blood-brain barrier","Ultrasounds","Innovative medical device","2026-08-06",{"date":199,"type":43},"2026-08-10",{"date":201,"type":43},"2026-07-15",{"date":203,"type":22},"2031-07-15",{"name":205,"class":50},"Assistance Publique - Hôpitaux de Paris",{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":212,"sex":17,"minAge":60,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":51},"100536559","evaluating-verbal-communication-in-structured-interactions-theoretical-and-clinical-implications-100536559","NCT06266403","Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications","Inclusion Criteria:\n\nSpeakers with amyotrophic lateral sclerosis (ALS) (PALS-people with ALS)\n\n* diagnosis of ALS following the revised EL Escorial criteria\n* no history of other neurological conditions (e.g., stroke)\n* no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA)\n* detectable speech disturbance according to the ALS Functional Rating Scale-Revised (ALSFRS-R)\n* the ability to produce single words\n* being a native speaker of American English (AE).\n\nAge-matched Speakers\n\n* passing the remote hearing screening\n* having no known speech, language, or neurological disorders per self-report\n* no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA)\n* being a functionally native monolingual speaker of American English.\n\nUnfamiliar Interlocutors\n\n* passing the remote hearing screening\n* having no known speech, language or neurological disorders per self-report\n* being a native monolingual speaker of American English\n* having no experience communicating with people with dysarthria\n* being between the ages of 18 and 40.\n\nExclusion Criteria:\n\n* None - if volunteer meets the inclusion criteria, then they will be enrolled",true,"90 Years",{"count":215,"type":22},300,[25],"The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and age-matched speakers.\n\nThe question is, What are the effects of communicative interaction on verbal communication in people with ALS?\n\nParticipants will read words and sentences while they are in a solo setting and interactive setting.",[31],{"date":170,"type":43},{"date":221,"type":43},"2024-11-05",{"date":223,"type":22},"2029-02-28",{"name":225,"class":50},"Penn State University",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100527444","french-german-cohort-study-to-determine-factors-associated-with-weight-loss-in-amyotrophic-lateral-sclerosis-100527444","NCT06147843","French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis","FG-CoALS","Inclusion Criteria:\n\n* Incident cases included at the time of diagnosis with a definite, probable, probable laboratory-supported, or possible ALS according to El Escorial revised criteria and Gold Coast criteria for early diagnosis.\n* Incident ALS cases identified and followed-up in the participant ALS \\& Other Motor Neuron Diseases Referral Centres: seven in France and two in Germany.\n* Patients who signed the informed consent form.\n* Adults aged \\>18 years old\n\nExclusion Criteria:\n\n* Inability to understand the requirements of the protocol.\n* Cognitive inability to sign and comprehend the informed consent form.\n* Patients who will not accept Riluzole therapy during their follow-up.",{"count":234,"type":22},1000,[25],"Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Studies have shown the importance of weight loss at the time of diagnosis and during the progression of the disease. However, the pathophysiological mechanisms behind weight loss remain unknown. Identifying these mechanisms could make it possible to propose an effective therapeutic strategy against weight loss for ALS patients, which could improve their survival and quality of life. In this context, the investigators are proposing an innovative multidisciplinary project aimed at structuring a large Franco-German cohort to identify the markers associated with weight loss in ALS.\n\nParticipants will undergo high quality standard care for ALS patients. In addition, participants will be asked to respond different questionnaires and blood samples will be taken for analysis to identify biological markers.",[31],[239,240,241,242,243,244,245],"Amyotrophic lateral sclerosis","Weight Loss","Genetics","Nutrition","Prognosis","Metabolomics","Inflammation","2026-08-05",{"date":197,"type":43},{"date":249,"type":43},"2024-09-17",{"date":251,"type":22},"2029-09-30",{"name":253,"class":50},"University Hospital, Limoges",9,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":276},"100644782","phase-1-function-als-aiming-to-restore-unc13a-function-in-people-living-with-als-100644782","NCT07674667","FUNCtion ALS: Aiming to Restore UNC13A Function in People Living With ALS","A Randomized, Double-Blind, Placebo-Controlled, Phase 1 \u002F 2 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of TRCN-1023 Administered by Intrathecal Injections to Adult People Living With Amyotrophic Lateral Sclerosis","FUNCtion ALS","Key Inclusion Criteria:\n\n* Adults aged 18 to 75 years\n* Diagnosis of ALS (clinically definite, clinically probable, or clinically probable laboratory supported)\n* ALS symptoms began within the past 24 months\n* Able to perform breathing tests: slow vital capacity (SVC) with consistent results, with breathing capacity of at least 60% of the expected value\n* Able and willing to meet all study requirements, including travel to the study site, brain magnetic resonance imaging (MRI) scans, lumbar punctures, and blood draws\n* Able and willing to use wearable sensors and complete speech assessments at home\n* On a stable dose of approved ALS medication for at least 4 weeks prior to screening\n* Capable of providing informed consent\n\nKey Exclusion Criteria:\n\n* Carries a confirmed SOD1 or FUS gene mutation\n* Has a tracheostomy or requires continuous assisted ventilation more than 22 hours per day during the preceding 3 months before the first Screening Visit\n* Has a contraindication to brain MRI (e.g., pacemaker, metal implants)\n* Has a contraindication to lumbar puncture or spinal injection (e.g., blood clotting disorders, certain blood thinners, signs of increased pressure in the brain)\n* Has significant abnormal liver, kidney, or blood test results\n* Is currently enrolled in another clinical trial or has received an investigational treatment within the past 4 weeks\n* Has previously received gene therapy, stem cell therapy, or another Antisense oligonucleotide (ASO) treatment\n* Has a clinically significant condition other than ALS that could interfere with study participation",{"count":264,"type":22},30,[65,66],"The FUNCtion Amyotrophic Lateral Sclerosis (ALS) trial is a randomized, double-blind, placebo-controlled Phase 1\u002F2 trial to evaluate the safety and tolerability of TRCN-1023 in adults living with ALS. TRCN-1023 is an investigational medicine given as a single injection into the fluid surrounding the spine (intrathecal injection). The trial will also assess how the body processes the drug and whether it shows early signs of benefit over 24 weeks.",[31],"2026-08-03",{"date":246,"type":43},{"date":271,"type":22},"2026-08",{"date":273,"type":22},"2027-09",{"name":275,"class":79},"Trace Neuroscience, Inc.",2,{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":51},"100562903","oral-intake-of-enteral-nutrition-formula-preceding-placement-and-feeding-via-gtube-and-its-impact-on-formula-intolerance-in-pals-100562903","NCT06609213","Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in pALS","Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via G-Tube and Its Impact on Formula Intolerance in pALS","Inclusion Criteria:\n\n* Diagnosis of possible, probable, or definite ALS or motor neuron disease by the treating neurologist (El-Escorial Revisited).\n* Planned tube feeding placement within the following 4 to 6 weeks.\n\nExclusion Criteria:\n\n* History of Crohns disease, inflammatory bowel disease, irritable bowel syndrome, celiac disease, food allergies and\u002For sensitivities to any of the formula ingredients, neurodegenerative disease diagnosis outside of ALS, or other concomitant disorder that might contribute to GI symptoms.\n* Diagnosis of frontotemporal dementia.\n* Nil per oral status.\n* Any reason causing the immediate need for a feeding tube placement, including but not limited to severe malnutrition diagnosis.",{"count":285,"type":22},22,[25],"The main objective of the proposed study is to evaluate if oral intake of EN formula preceding Gtube placement will impact tolerance upon placement and feeding via Gtube in pALS. This single arm intervention study all participants will receive the intervention and researchers will utilize validated indicators combined with clinical expertise to assess gastrointestinal symptoms of feeding intolerance before and after the intervention.\n\nThe main questions this study aims to answer are:\n\n1. Wil participants meeting a greater percentage of their estimated nutritional needs at baseline present a slower disease progression rate and a lower incidence of GI symptoms of feeding intolerance when feeding via Gtube?\n2. Will there be significant change in feeding intolerance when oral intake of enteral nutrition formula precedes feeding via Gtube?\n\nThis proposed study consists of three stages, as follows:\n\n1. Pre-Intervention: The lead in period of one-week preceding intervention phase I will be timed to initiate 3 weeks before the scheduled Gtube placement procedure. Patients will be advised to maintain their usual food and beverage intake. Dietary intake and GI symptoms data will be collected by research personnel.\n2. Phase I: Dietary intake data collected from the pre-intervention stage will be averaged and used to determine the number of cartons of enteral nutrition formula needed to meet the participants estimated nutritional needs. For two weeks +- 2 days participants will be directed to drink the number of cartons of a pre-selected enteral nutrition formula to meet their estimated nutritional needs when combined to their current oral dietary intake. A plant based EN formula (Kate Farms 1.4 Standard) commonly prescribed for pALS was selected to be provided to all patients in the study to keep this variable constant. Weekly data collection of dietary intake and GI symptoms will be ongoing.\n3. Phase II: At the end of phase I, patients will undergo a Gtube placement at their selected medical facility. For the following two weeks +- 2 days participants will be directed to feed via Gtube the same number of cartons of the enteral nutrition formula used orally on phase I and make no changes to their current oral intake.",[31,289,290],"Gastrointestinal Intolerance","Enteral Nutrition Therapy",[98,33,292,293,294,295,296,297,298,299],"Gtube","enteral nutrition","feeding intolerance","EN intolerance","enteral nutrition intolerance","gastrointestinal symptoms","percutaneous endoscopic gastrostomy","PEG",{"date":301,"type":43},"2026-08-04",{"date":303,"type":43},"2025-01-10",{"date":305,"type":22},"2026-12",{"name":307,"class":50},"Andrea Charvet",{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":212,"sex":17,"minAge":60,"maxAge":213,"enrollmentInfo":315,"targetDuration":317,"studyType":118,"phases":4,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":324,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":328,"leadSponsor":330,"locationsCount":51},"100619185","digital-speech-markers-for-monitoring-als-in-spanish-speakers-100619185","NCT07341334","Digital Speech Markers for Monitoring ALS in Spanish Speakers","Developing Digital Speech Biomarkers of Bulbar Disease Decline in Spanish-Speaking Persons With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n* diagnosis of definite ALS\n* monolingual or first language Spanish speaker\n* literate in Spanish\n* ALS Functional Rating Scale speech score of ≧2\n\nExclusion Criteria:\n\n* no diagnosis of concomitant respiratory disease such as COPD, emphysema, or current TOB use.",{"count":316,"type":22},35,"4 Years","The goal of this observational study is to learn how speech and breathing change over time in Spanish-speaking individuals with amyotrophic lateral sclerosis (ALS) compared to age- and gender-matched individuals without ALS.\n\nThe main questions it aims to answer are:\n\nCan speech and breathing measures collected through a smartphone application serve as reliable digital biomarkers to track bulbar disease decline in Spanish-speaking people with ALS?\n\nHow do these measures differ between individuals with ALS and those without ALS?\n\nResearchers will compare Spanish-speaking participants with ALS to age- and gender-matched healthy controls to see if specific speech and breathing features can identify or predict bulbar decline.\n\nParticipants will:\n\nUse a Spanish-language smartphone application to record speech and breathing tasks over time.\n\nComplete assessments of speech, breathing, and functional abilities (e.g., ALS Functional Rating Scale).\n\nProvide data that will be compared to caregiver reports and clinical outcomes to validate new digital biomarkers.",[31,320,33],"Lou Gehrig's Disease",[322,98,323,33],"speech biomarkers","Lou Gehrig's disease","NOT_YET_RECRUITING","2026-07-31",{"date":268,"type":43},{"date":271,"type":22},{"date":329,"type":22},"2029-12",{"name":331,"class":50},"Nova Southeastern University",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":21},"100572572","multicenter-als-imaging-study-100572572","NCT06735014","Multicenter ALS Imaging Study","Multicenter Longitudinal Imaging in ALS for Disease Biomarker Development","For participants with ALS:\n\n* \\\u003C 36 months since onset of symptoms\n* Definite, probable, lab-supported probable, or possible ALS by El Escorial criteria OR definite, probable, or possible ALS per Awaji-Shima criteria OR meets Gold Coast criteria\n* Forced vital capacity within the last 90 days ≥ 60% of the predicted value\n* Able to consent for themselves\n* Able to read and speak English\n* Clear of any contraindications for MRI\n\nExclusion Criteria:\n\n* Individuals will be excluded if they have any condition that makes MRI unsafe or if they are unable to comply with instructions.\n* All participants will undergo a neurologic examination at enrollment. Control participants with clinically significant abnormal findings on neurological examination will be excluded from the study.",{"count":340,"type":22},90,"This is a multi-site study of ALS participants and healthy controls who will undergo brain and cervical spine MRIs and NfL blood testing at up-to 4 time points over the course of a year. The primary goal is to identify objective biomarkers of disease progression that are biologically relevant, linearly progressive, and sensitive to change.",[31,33],[344,345,346,347,348,349],"Magnetic Resonance Imaging","MRI","ALSFRS-R","ECAS","plasma neurofilament light","NfL","2026-07-30",{"date":325,"type":43},{"date":353,"type":43},"2024-09-15",{"date":355,"type":22},"2028-08-31",{"name":357,"class":50},"University of Minnesota",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":51},"100537925","qct-in-als-diagnosis-mechanistic-understanding-and-follow-up-100537925","NCT06284161","QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up","Contribution of the Combined Quadriceps Test (QCT) in the Diagnosis, Mechanistic Understanding and Follow-up of Amyotrophic Lateral Sclerosis","PEM-SLA","Inclusion Criteria:\n\n* A male or female patient of legal age with suspected ALS (bulbar or spinal) who meets the criteria for \"possible\", \"probable\" or \"definite\" ALS according to the Awaji criteria\n* Able to give informed consent to participate in the research\n* Enrolled in a Social Security plan\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Severe progressive pathology other than ALS.\n* Comorbidities with another neurological disease altering motor skills.\n* Contraindication to trans-cranial magnetic stimulation: epilepsy, pacemaker, intracranial ferromagnetic foreign body (clip, aneurysm, implants)...\n* Chronic alcoholism\n* Cognitive disorders or major incapacity making it impossible to understand the study and sign an informed consent (fronto-temporal dementia, psychiatric conditions of psychotic type, language disorders)\n* Refusal to participate.\n* Patients under legal protection (guardianship, curators, safeguard of justice)",{"count":264,"type":22},[25],"Multidisciplinary management of amyotrophic lateral sclerosis (ALS) can significantly increase survival but also improve the quality of life of patients. The evaluation of cortical-spinal motor neuron damage is currently based only on the assessment of clinical data. However, the alteration of the central motor pathway and conduction can be identified and quantified by different techniques using motor-evoked potentials (MEP). The combined quadriceps test (QCT) has been developed to assess central and peripheral motor pathway conduction. This test allows to quantify central and peripheral part of a mixed disorder, and to detect physiological hyporeflexia or hyperreflexia which, in the case of suspected ALS, can lead to interpretation problems.\n\nThe evolution of the QCT parameters during the course of pathology will lead to determine the preponderance of an initial central involvement, but also its extension throughout the pathology. The study of these parameters as well as the clinical course of the disease could reveal a correlation between peripheral and central involvement. This link would provide arguments in favor of pathophysiological hypotheses of disease onset and progression. From a prognostic point of view and depending on the quantification of central and peripheral involvement, the QCT would make it possible to characterize the different ALS phenotypes. This phenotypic characterization would help identify prognostic factors at diagnosis.\n\nThe investigators propose a cohort study with the exploration of central motor neuron damage by QCT during the course of ALS in order to provide arguments for a better mechanistic understanding and follow-up of this disease with a poor prognosis.",[31],[371,31],"Quadriceps Combined Test","2026-07-29",{"date":350,"type":43},{"date":375,"type":43},"2022-06-28",{"date":377,"type":22},"2030-06",{"name":379,"class":50},"University Hospital, Clermont-Ferrand",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":212,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":410},"100390419","artfl-lefftds-longitudinal-frontotemporal-lobar-degeneration-allftd-100390419","NCT04363684","ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)","Longitudinal Arm Inclusion Criteria\n\nFamilial FTLD (f-FTLD) participants (either is acceptable):\n\n* members of families in whom at least one member has a known disease-associated mutation in one of the major genes that cause f-FTLD: MAPT, GRN, C9orf72 (or other rare genes)\n* an autosomal dominant family history of a FTLD syndrome (without a known gene) verified by medical record review or well-documented family history including family members with a medical history consistent with FTLD or a related disorder.\n\nSporadic FTLD (s-FTLD) participants:\n\nSporadic participants should be symptomatic with no known family history nor a genetic mutation indicating f-FTLD. All sporadic participants must have an FTLD syndrome as a referring diagnosis; those determined by ALLFTD clinicians to have non-FTLD diagnoses will be excluded from longitudinal visits, but their baseline visit will be included in comparative datasets. For inclusion in the longitudinal follow-up, participants should meet research criteria for one of the following FTLD syndromes:\n\n* Progressive Supranuclear Palsy (PSP)\n* Semantic variant Primary Progressive Aphasia (svPPA)\n* Nonfluent variant Primary Progressive Aphasia (nfvPPA)\n* Corticobasal Degeneration (CBD)\u002FCorticobasal Syndrome (CBS)\n* Behavioral variant Frontotemporal dementia (bvFTD)\n* Frontotemporal Dementia with Amyotrophic Lateral Sclerosis (FTD\u002FALS)\n\nBiofluid-Focused Arm Inclusion Criteria\n\nParticipants enrolled in the biofluid arm may be either f-FTLD or s-FTLD. All general inclusion criteria apply. Participants should meet research criteria (as specified above) for any FTLD syndrome or meet familial FTLD inclusion criteria. Because the biofluid arm participants do not undergo the same detailed clinical and functional assessments required for the longitudinal arm, participants may be included regardless of primary language, as long as an appropriately translated consent is available.\n\nExclusion Criteria:\n\n* Known presence of a structural brain lesion (e.g. tumor, cortical infarct) that could reasonably explain symptoms in a symptomatic participant.\n* Known presence of an Alzheimer's disease causing mutation in PSEN1, PSEN2 or APP; or biomarker evidence for Alzheimer's disease as a cause of the clinical syndrome.\n* A previous history of Korsakoff encephalopathy, severe alcohol dependence (within 5 years of onset of dementia), frequent alcohol or other substance intoxication, or other neurological disorder.\n* Evidence through history or laboratory testing of uncorrected B12 deficiency (B12 \\\u003C 95% of local laboratory's normal value), unregulated hypothyroidism (TSH \\>150% of normal), HIV positive, renal failure (creatinine \\> 2), liver failure (ALT or AST \\> two times normal), respiratory failure that requires supplemental oxygen, large confluent white matter lesions, significant systemic medical illnesses such as deteriorating cardiovascular disease.\n* Current medication likely to affect CNS functions in the opinion of the site PI.\n* In the site investigator's opinion, the participant cannot complete sufficient key study procedures. The participant may be enrolled into the biofluid-focused arm if they can tolerate a blood draw and short clinical exam, but must be able to complete at least 75% of study procedures for enrollment into the longitudinal arm.",{"count":387,"type":22},2100,"ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01 AG045390; funded through 2019) as a single North American research consortium to study FTLD for 2019 and beyond.",[390,391,392,393,394,395,396,31,397,398,399,400,401,402],"Frontotemporal Lobar Degeneration (FTLD)","Progressive Supranuclear Palsy (PSP)","Corticobasal Degeneration (CBD)","Behavioral Variant Frontotemporal Dementia (bvFTD)","Semantic Variant Primary Progressive Aphasia (svPPA)","Nonfluent Variant Primary Progressive Aphasia (nfvPPA)","FTD With Amyotrophic Lateral Sclerosis (FTD\u002FALS)","Oligosymptomatic PSP (oPSP)","C9orf72","GRN Related Frontotemporal Dementia","MAPT Gene Mutation","TBK1 Gene Mutation","Oligosymptomatic Progressive Supranuclear Palsy",{"date":350,"type":43},{"date":405,"type":43},"2020-03-01",{"date":407,"type":22},"2030-08-31",{"name":409,"class":50},"Mayo Clinic",27,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":212,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":420,"conditions":421,"keywords":422,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":434},"100560800","prevent-all-als-study-100560800","NCT06581861","PREVENT ALL ALS Study","PREVENT ALL ALS - Longitudinal Biomarker Study for Participants Who Are Genetically at Risk for Amyotrophic Lateral Sclerosis (ALS)","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. First-degree relative of a known carrier of any ALS causative gene1 (regardless of whether ALS or FTD has actually been symptomatic in the family) OR First-degree relative of an individual with ALS and\u002For FTD in a family with a \"compelling family history\" of ALS\u002FFTD, regardless of whether genetic testing has occurred in symptomatic family members. A \"compelling family history\" is defined as a pedigree with at least 2 close relatives who had ALS or FTD, with at least one of those family members having had ALS.\n5. Access to a smartphone, computer, or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nExclusion Criteria:\n\n1. Evidence of neurological signs or symptoms concerning for ALS of FTD, at the discretion of the site investigator which will be communicated to the applicant along with referral for appropriate clinical follow-up.\n2. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \\\u003C= 90 days (about 3 months) of screening, which in the opinion of the Investigator would interfere with the study procedures\n3. Clinically significant, unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment\n\nExclusion Criteria for Participants Undergoing Optional Lumbar Puncture\n\n1. Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).\n2. Allergy to Lidocaine or other local anesthetic agents.\n3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.\n4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.\n5. Current pregnancy based on participant self-report\n6. Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.\n\nInclusion Criteria for Genetic Testing Results Sub-study\n\n1. Age 18 years of age or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. Currently enrolled in the PREVENT ALS Study",{"count":419,"type":22},600,"The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is begin funded by the National Institutes of Health\u002FNational Institute of Neurological Disorders and Stroke (NIH\u002FNINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases.\n\nPREVENT protocol is specific for asymptomatic participants who are genetically at risk for ALS. The participants will be followed for up to 36 months (3 years), and will include 4 in-person on-site visits once a year and 6 off-site(remote) visits once in 4 months. The study includes collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once in 4 months. Participants may also provide optional Cerebrospinal Fluid (CSF) samples.The participants may also opt into a sub-study if they are interested in genetic testing for ALS causative genes. The sub-study will involve a minimum of 3 visits over a course of 2-3 months. This will include a screening\u002Fpre-test genetic counseling visit, a return of genetic results and a post-test counseling visit.",[31],[33,31,423,424,425],"Biomarker","Observational","at-risk","2026-07-28",{"date":350,"type":43},{"date":429,"type":43},"2024-07-25",{"date":431,"type":22},"2029-07-25",{"name":433,"class":50},"St. Joseph's Hospital and Medical Center, Phoenix",32,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":212,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":444,"conditions":445,"keywords":446,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":451,"leadSponsor":452,"locationsCount":453},"100560518","assess-all-als-study-100560518","NCT06578195","ASSESS ALL ALS Study","ASSESS ALL ALS - Longitudinal Biomarker Study for Symptomatic ALS and Control Participants","Inclusion Criteria for ALS participants:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. Diagnosis of ALS by a physician\n5. Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nInclusion Criteria for control participants:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)\n5. No history of familial ALS\u002FFrontotemporal Dementia (FTD) in a close family member\\*\\* unless the participant has previously tested negative for the known causative ALS genes. Participants with a family history of singleton ALS are permitted to enroll.\n\n   * \\*\\* Defined by the presence of a known ALS causative gene such as C9orf72 in a family member or a family history suggestive of an inherited ALS\u002FFTD syndrome defined by two family members with a history of ALS and\u002For FTD.\n6. Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nExclusion Criteria for all participants:\n\n1. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \\\u003C= 90 days of screening, that would interfere with the study procedure, according to Investigator's judgement.\n2. Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment.\n\nExclusion Criteria for participants undergoing optional Lumbar Puncture\n\n1. Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).\n2. Allergy to Lidocaine or other local anesthetic agents.\n3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.\n4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.\n5. Current pregnancy based on participant self-report\n6. Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.",{"count":443,"type":22},2000,"The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is being funded by the National Institutes of Health\u002FNational Institute of Neurological Disorders and Stroke (NIH\u002FNINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases.\n\nASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.",[31],[33,31,447,448],"biomarker","observational",{"date":350,"type":43},{"date":429,"type":43},{"date":431,"type":22},{"name":433,"class":50},37,{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":89,"enrollmentInfo":461,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":324,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":51},"100475403","ibci-optimization-for-veterans-with-paralysis-100475403","NCT05470478","iBCI Optimization for Veterans With Paralysis","Enhancement and Optimization of a Mobile iBCI for Veterans With Paralysis","Inclusion Criteria:\n\n* Inclusion criteria are extensive and are determined by the associated BrainGate IDE(clinicaltrials.gov # NCT00912041)\n* Informally, participants will be tetraplegic or anarthric with little or no functional use of the arms and legs\n\nExclusion Criteria:\n\n* Exclusion criteria are extensive and are determined by the associated BrainGate IDE(clinicaltrials.gov # NCT00912041).",{"count":276,"type":22},[25],"VA research has been advancing a high-performance brain-computer interface (BCI) to improve independence for Veterans and others living with tetraplegia or the inability to speak resulting from amyotrophic lateral sclerosis, spinal cord injury or stoke. In this project, the investigators enhance deep learning neural network decoders and multi-state gesture decoding for increased accuracy and reliability and deploy them on a battery-powered mobile BCI device for independent use of computers and touch-enabled mobile devices at home. The accuracy and usability of the mobile iBCI will be evaluated with participants already enrolled separately in the investigational clinical trial of the BrainGate neural interface.",[465,31,466,29,467],"Spinal Cord Injury","Brain Stem Infarctions","Muscular Dystrophy","2026-07-23",{"date":470,"type":43},"2026-07-27",{"date":472,"type":22},"2026-10-02",{"date":474,"type":22},"2027-06-30",{"name":476,"class":477},"VA Office of Research and Development","FED",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":89,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":498},"100636862","phase-1-a-master-protocol-olmp-a-study-of-ly4256984-in-participants-with-amyotrophic-lateral-sclerosis-als-100636862","NCT07571200","A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)","A Master Protocol for Open-Label Extension Studies to Evaluate the Long-Term Safety and Tolerability of Interventions in Various Stages of Clinical Development in Participants With Amyotrophic Lateral Sclerosis","Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll.\n\nInclusion Criteria:\n\n* Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS.\n\n  * Note 1: To be considered a \"completer\" of a parent study, the participant must finish the main treatment period\u002Fphase of the parent study as well as any off-treatment period\u002Fphase as described in the parent study's protocol.\n  * Note 2: Visits missed in a parent study will have no impact on the completer status of a potential participant.\n\nExclusion Criteria:\n\n* During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator.\n* During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator.\n* During the parent study, the participant developed an unresolved SAE or a medical illness (other than ALS) that, in the opinion of the investigator, precludes either continued exposure to an IMP or participation in study procedures due to an unacceptable risk to the participant's safety.",{"count":434,"type":22},[65],"Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174). The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that will last at least 96 weeks.",[31],"2026-07-16",{"date":491,"type":43},"2026-07-17",{"date":493,"type":43},"2026-05-14",{"date":495,"type":22},"2029-06",{"name":497,"class":79},"Eli Lilly and Company",10,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":89,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":512,"leadSponsor":513,"locationsCount":498},"100636860","phase-1-a-substudy-of-ly4256984-in-participants-with-sporadic-amyotrophic-lateral-sclerosis-100636860","NCT07571174","A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis","A Study of Long-Term Safety, Tolerability, and Clinical Outcomes of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis: A Multicenter, Open-Label, Long-Term Extension of Study J6I-MC-OWAA","Participants must meet eligibility criteria in the \\[L0U-MC-OLMP\\] screening protocol before entry into the treatment study.\n\nInclusion Criteria:\n\n* Have completed the main treatment period\u002Fphase as well as any off-treatment period\u002Fphase of Study OWAA, the parent study for this ISA.\n\nExclusion Criteria:\n\n* The participant has conditions that preclude a lumbar puncture (LP), such as:\n\n  * A history of clinically significant back pain, back pathology, and\u002For back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP.\n  * Allergy to local anesthetics, such as lidocaine or its derivatives.\n  * A local infection at the intended site of the LP.\n  * Less than 100 giga per liter \\[(\\\u003C100 GI\u002FL) is equivalent to 100,000 per cubic millimeter (100,000\u002Fmm³)\\] platelets or clinically significant coagulation abnormality or significant active bleeding, or\n  * Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted.",{"count":434,"type":22},[65],"The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.",[31],{"date":491,"type":43},{"date":493,"type":43},{"date":495,"type":22},{"name":497,"class":79},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":213,"enrollmentInfo":520,"targetDuration":522,"studyType":118,"phases":4,"briefSummary":523,"conditions":524,"keywords":525,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":51},"100444419","analysis-of-human-als-tissues-and-registry-of-als-patients-100444419","NCT05067179","Analysis of Human ALS Tissues and Registry of ALS Patients","Inclusion Criteria:\n\n* Patients over the age of 18\n* Established diagnosis of ALS\n* Able and willing to give written informed consent and must authorize release and use of protected health information\n\nExclusion Criteria:\n\n* Patients below the age of 18\n* No diagnosis of ALS",{"count":521,"type":22},40,"5 Years","Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig's Disease, is a progressive, terminal condition of muscle weakness that is associated with degeneration of neurons in the spinal cord and brain. This devastating disorder afflicts people in the prime of their lives. At the present time, there are no cures for this disorder, and current treatments are marginal at best. Despite years of intensive research, a fundamental understanding of this disease is still lacking. There is a need to identify both reliable markers of disease progression and effective treatments. The goal of this research is to bring a greater understanding of ALS patients closer to the research studies that can lead to new hypotheses and approaches.",[31],[526,320,527,528,529],"Amyotrophic Lateral Sclerosis (ALS)","Neurodegenerative Diseases","Neuromuscular Diseases","Nervous System Diseases","2026-07-06",{"date":532,"type":43},"2026-07-08",{"date":534,"type":43},"2020-09-01",{"date":536,"type":22},"2030-01-01",{"name":538,"class":50},"University of Illinois at Chicago",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":23,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":324,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":552,"leadSponsor":553,"locationsCount":4},"100245822","phase-1-study-to-investigate-the-safety-of-the-transplantation-by-injection-of-human-glial-restricted-progenitor-cells-hgrps-q-cells-into-subjects-with-amyotrophic-lateral-sclerosis-als-100245822","NCT02478450","Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS)","A Phase 1\u002F2a Open-Label Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS): Assessment of Localized Therapeutic Activity by Blinded Observation and Lateral Transplantation (ALTA-BOLT)","Inclusion Criteria:\n\n1. Subject has the ability to understand the purpose and risks of the study and provide a signed and dated informed consent and authorization to collect and use protected health information (PHI) in accordance with national and local subject privacy regulations.\n2. Subject lives within reasonable driving distance of study center (approximately 3 hours).\n3. Subject has a caregiver willing\u002Fable to assist in the transportation and care required by study participation.\n4. Subject is 18 - 80 years of age (inclusive) on the first day of the Screening Period.\n5. Subject is diagnosed with sporadic or familial ALS within the past 48 months.\n6. Subject meets the laboratory-supported probable, clinically probable, or definite criteria for diagnosing ALS according to the World Federation of Neurology El Escorial criteria.\n7. Subject has an upright FVC ≥65% of predicted value for age, height, and gender at Screening.\n8. Subject has not taken riluzole for at least 30 days prior to the first day of the Screening Period, or has been on a stable dose of riluzole for at least 30 days prior to the first day of the Screening Period (Riluzole-naïve subjects are permitted in the study).\n9. Subject is medically able to undergo the study procedures and physically able to adhere to the visit schedule at the time of study entry.\n10. Women of childbearing capacity must have a negative pregnancy test during the Screening Period and at the Pre-Operative Visit.\n11. Subject must agree to practice effective birth control during study participation.\n\nExclusion Criteria:\n\n1. Subject in whom causes of neuromuscular weakness other than ALS have not been practically excluded.\n2. Subject with a diagnosis of significant cognitive impairment, clinical dementia, or major psychiatric illness including psychosis, bipolar disease, major depression, as determined by the DSM-V.\n3. Subject with a diagnosis of other neurodegenerative disease (e.g., Parkinson's disease, Alzheimer's disease).\n4. Subject with a diagnosis of any medical condition that impairs nerve or muscle function (e.g., notable peripheral neuropathy, metabolic muscle disease).\n5. Subject with a clinically significant history of unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease or other medically significant illness, which, in the opinion of the Investigator, would preclude study participation.\n6. Subject with a history of spine surgery or anatomic variation incompatible with route of administration (as determined by neurosurgeon).\n7. Subject with severe cervical or lumbar stenosis, cord compression, or cervical or lumbar myelopathy.\n8. Subject with abnormal flow voids on the surface of the spinal cord suggestive of arteriovenous malformation (AVM).\n9. Subject demonstrating any evidence of CNS malignancy or CNS lesions as defined by imaging studies of the CNS (MRI of brain and spinal cord).\n10. Subject having uncontrolled hypertension (Systolic BP\\>180mmHg and\u002For Diastolic BP \\>110mmHg) or having a history of thrombotic events or poorly controlled medical conditions that, in the opinion of the Investigator and\u002For surgeon, increase risk of surgery.\n11. Subject who cannot undergo MRI examination because of the presence of a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices, or who have been or might have been exposed to metal fragments, or any reason the subject cannot undergo an MRI routinely for the duration of the trial.\n12. Subject with clinically significant abnormal clinical laboratory values, as determined by the Investigator during the Screening Period.\n13. Subject who is immune compromised or who has a condition contraindicated to treatment with immunosuppression agents (e.g., tuberculosis, latent infection).\n14. Subject with an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \\>3.0 times the upper limit of normal or creatinine \\>1.5 times the upper limit of normal and\u002For eGFR \\\u003C50cc\u002Fmin during the Screening Period.\n15. Subject with a history of alcohol or drug abuse or dependence within 1 year of the first day of the Screening Period, per DSM-V criteria.\n16. Subject unlikely to comply with study requirements, as determined by Investigator.\n17. Subject who has been exposed to any other experimental agent (off-label use or investigational) within 30 days of the first day of the Screening Period. Biologic agents may need additional time for washout and will be evaluated by the Sponsor on a case-by-case basis.\n18. Subject who has previously been administered stem cells.\n19. Subject with pre-existing anti-human leukocyte antigen (HLA) class I or class II antibodies directed against the Q-Cells®, as determined by panel reactive antibody (PRA) assay during the Screening Period.\n20. Subject with an allergy to Q-Cells® or any of its constituents (e.g., chicken eggs), or an allergy to any of the co-administered immunosuppressants or any of their excipients.\n21. Subject with any medical condition or using concomitant medication that would contraindicate the use of tacrolimus, mycophenolate mofetil, or prednisone as determined by Investigator.\n22. Subject with evidence of deep vein thrombosis (DVT) by venous ultrasound or any previous evidence of DVT.\n23. Subject who, in the opinion of the Investigator, has taken or is taking concomitant medications, supplements, or other agents that may interfere with the safety evaluation of Q-Cells® or may affect the course of the subject's ALS progression.",{"count":264,"type":22},[65,66],"This study is a non-randomized, open-label, partially blinded, sequential cohort, dose-escalation study designed to obtain preliminary data on the safety, tolerability, and early efficacy of Q-Cells® transplantation in subjects with ALS. Following an initial cohort receiving cell transplants unilaterally in the lumbar spinal cord, subsequent cohorts will receive escalating doses transplanted unilaterally in cervical spinal cord. Subjects and outcome measure assessors will be blinded to side of treatment. The study will be conducted at sites with extensive clinical experience with the care of patients with ALS.",[31],{"date":532,"type":43},{"date":305,"type":22},{"date":329,"type":22},{"name":554,"class":79},"Q Therapeutics, Inc.",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":23,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":80},"100615242","phase-1-a-study-to-investigate-the-safety-and-pharmacodynamics-of-a-single-intrathecal-injection-it-of-ins1202-in-participants-with-amyotrophic-lateral-sclerosis-als-100615242","NCT07290062","A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)","A Phase 1, Multicenter, Open-label, Dose-Finding Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection of INS1202 in Patients With Amyotrophic Lateral Sclerosis","ARMOR","Key Inclusion Criteria: -\n\n* Participant with body mass index (BMI) ≥18 kilograms per square meter (kg\u002Fm\\^2).\n* Participant with symptomatic ALS as diagnosed by Gold Coast diagnostic criteria.\n* Sporadic ALS cohorts: Negative testing for known monogenic mutations associated with familial ALS.\n* SOD1-ALS (Cohorts 2 and 3 only): Confirmed pathogenic SOD1 mutation, with negative testing for other genetic mutations associated with familial ALS.\n* Any polymorphism or mutation in the coding region will require additional review by the Sponsor to determine compatibility with the study intervention.\n* Baseline ALSFRS-R ≥ 24.\n* ALS disease duration ≤ 42 months.\n\nKey Exclusion Criteria: -\n\n* Previous treatment for ALS with cellular or gene therapies.\n* Any investigational medication or treatment (for ALS or other condition).\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","79 Years",{"count":186,"type":22},[65],"The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \\\u003C80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.",[31],"2026-07-02",{"date":530,"type":43},{"date":571,"type":43},"2026-01-09",{"date":573,"type":22},"2030-03-31",{"name":575,"class":79},"Insmed Gene Therapy LLC",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":586,"conditions":587,"keywords":607,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":21},"100270060","neurologic-stem-cell-treatment-study-100270060","NCT02795052","Neurologic Stem Cell Treatment Study","Neurologic Bone Marrow Derived Stem Cell Treatment Study","NEST","Inclusion Criteria:\n\n1. Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.\n2. Be at least 6 months post-onset of the disease.\n3. If under current medical therapy (pharmacologic or surgical treatment) for the condition be considered stable on that treatment and unlikely to have reversal of the associated neurologic functional damage as a result of the ongoing pharmacologic or surgical treatment.\n4. In the estimation of Dr. Weiss and the neurologists have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.\n5. Be over the age of 18 and capable of providing informed consent.\n6. Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.\n\nExclusion Criteria:\n\n1. All patients must be capable of an adequate neurologic examination and evaluation to document the pathology. This will include the ability to cooperate with the exam.\n2. Patients must be capable and willing to undergo follow up neurologic exams with the sub-investigators or their own neurologists as outlined in the protocol.\n3. Patients must be capable of providing informed consent.\n4. In the estimation of Dr. Weiss the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function. .\n5. Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.\n6. Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.",{"count":145,"type":22},[25],"This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1\u002F3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http:\u002F\u002Fmdstemcells.com\u002Fnest\u002F",[588,529,527,589,37,590,591,592,593,594,595,596,597,598,599,122,33,31,600,601,602,603,121,604,605,606],"Neurologic Disorders","Neurological Disorders","Traumatic Brain Injury","Cadasil","Chronic Traumatic Encephalopathy","Cerebral Infarction","Cerebral Ischemia","Cerebral Stroke","Cerebral Hemorrhage","Parkinson","Multi-System Degeneration","MSA - Multiple System Atrophy","Neuropathy","Diabetic Neuropathies","Alzheimer Disease","Dementia","Lewy Body Disease","Cognitive Impairment","Lewy Body Variant of Alzheimer Disease",[608,609,37,590,610,611,600,612,594,605,603,613],"Neurologic Disease","Cerebral Vascular Accident","Multiple Sclerosis","Parkinsons Disease","Diabetic Neuropathy","Neurodegeneration","2026-06-24",{"date":616,"type":43},"2026-06-26",{"date":618,"type":43},"2016-06",{"date":620,"type":22},"2028-07-31",{"name":622,"class":79},"MD Stem Cells",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":33,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":633,"conditions":634,"keywords":635,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":645},"100615038","phase-1-study-is-to-assess-the-safety-and-tolerability-of-vtx-002-in-participants-with-als-100615038","NCT07287397","Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS","Phase 1\u002F2 Investigation of Novel Experimental Regimen in Amyotrophic Lateral Sclerosis (Pioneer-ALS): An Open-Label, Uncontrolled, Multicenter Study to Assess the Safety and Tolerability of Two Doses of VTx-002","Key Inclusion Criteria:\n\n1. Capable of, and willing to, provide written informed consent and comply with study procedures, including visits to the study site and visit requirements\n2. Male or female ≥ 18 years of age\n3. Has a diagnosis of ALS according to the El Escorial criteria (Brooks, et al., 2000) (probable, laboratory results supported; clinically probable, clinically definite)\n4. Confirmed absence of ALS caused by FUS and SOD1 gene mutations confirmed by laboratory tests.\n5. A maximum of 18 months since first appearance of weakness (e.g., limb weakness, dysarthria, dysphagia, shortness of breath)\n6. Erect (seated) SVC % predicted ≥ 80% at Screening\n7. Treatment Research Initiative to Cure ALS (TRICALS) risk score between -2 and -6 at Screening\n8. Has a reliable caregiver\u002Fpartner\u002Flegal representative willing and able to support the participant in participation in the study and to give informed consent on behalf of the participant in the case that disease progression prevents the participant of giving consent (local legal rules will apply).\n9. Treatment with riluzole and\u002For edaravone is allowed if treatment was started and has remained at a stable dose for at least 2 weeks (riluzole) or one treatment cycle (edaravone) before the Screening visit\n10. Women of childbearing potential (WOCBP) and male participants with female partners who are WOCBP must agree to use highly effective contraception during and after the study. WOCBP cannot be pregnant or breastfeeding\n11. Women of nonchildbearing potential must be post-menopausal or surgically sterile (e.g. hysterectomy, bilateral tubal ligation, ovaries removed)\n\nKey Exclusion Criteria:\n\n1. Diagnosis of a significant CNS or peripheral nervous system disease other than ALS that may be a cause for the participant's ALS symptoms or may confound study objectives\n2. Spinal, cervical, or brain MRI\u002FMRA indicating clinically significant abnormality\n3. Presence of tracheostomy and feeding tube at Screening\n4. Contraindications to corticosteroid use (e.g. due to osteoporosis, uncontrolled blood pressure, diabetes or cholesterol).\n\n5\\. Significant concomitant disease or condition within 6 months of Screening that could pose an unacceptable safety risk to the participant or interfere with the participant's ability to comply with study procedures, e.g. heart disease, uncontrolled diabetes, liver disease, autoimmune diseases needing strong immune-suppressing drugs, cancer, etc or a current psychiatric diagnosis.\n\n6\\. Clinically significant abnormalities in laboratory test results at Screening for example poor liver or kidney function, abnormal clotting or infections such as Hepatitis or HIV\n\n7\\. Use of blood thinners (e.g., warfarin, heparin, and novel oral anticoagulants) and being unable to safely stop them before certain study procedures.\n\n8\\. Contraindications to imaging methods MRI, MRA, CT due to claustrophobia and\u002For intolerance to contrast agents.\n\n9\\. Contraindications to general anaesthesia (GA) or deep sedation\n\n10 Positive test for illegal drugs (except prescribed medications or permitted medicinal\u002Frecreational marijuana if used responsibly)\n\n11\\. Generally frail or if the Investigator deems participation in the study would not be in the best interest of the participant or is likely to prohibit further participation during the study\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply\n\n\\-",{"count":631,"type":22},12,[65,66],"PIONEER-ALS is a Phase 1\u002F2, multicenter, open-label, ascending dose, uncontrolled, first-in-human study that will evaluate the safety, tolerability and effects on clinical and biomarker endpoints of intracisternal administration of Vtx-002 in participants with Amyotrophic Lateral Sclerosis (ALS).\n\nTwo escalating dose (low dose and high dose) cohorts are planned. The duration of the study will be a maximum of 5 years and 5 weeks (265 weeks) for each participant. The screening period may last up to 5 weeks to complete screening procedures.",[31],[33],"2026-06-22",{"date":638,"type":43},"2026-06-23",{"date":640,"type":43},"2025-12-19",{"date":642,"type":22},"2027-10-15",{"name":644,"class":79},"Vector Y Therapeutics",11]