[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"parkinson-disease-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:parkinson-disease-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,62,0,25,[9,51,80,111,136,157,186,213,235,261,282,312,338,362,381,406,435,460,483,505,528,555,582,605,624],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100636600","gbpdc-gut-brain-in-pd-consortium-master-protocol-100636600",false,"NCT07567794","GBPDC: Gut-Brain in PD Consortium Master Protocol","Consortium for Gut-Brain Communication in Parkinson's Disease Master Protocol","GBPDC","Inclusion Criteria (All PD Cohorts)\n\n1. Aged ≥21 years old and ≤80 years old\n2. Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria\n3. Adequate visual, hearing, cognitive, and physical ability\n4. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Because longitudinal participation is important to the scientific goals of the program, a \"best estimate\" of interest, commitment, and geographic feasibility for three years will be documented by the enrolling investigator after interview with the potential enrollee\n\nInclusion Criteria Controls\n\n1. Aged ≥21 years old and ≤80 years old\n2. No known or diagnosed neurodegenerative disease\n3. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures\n4. Resides within the same household as person with PD\n\nInclusion Criteria Prodromal Cohort\n\n1. Aged ≥21 years old and ≤80 years old\n2. Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile.\n\nExclusion Criteria (All Cohorts)\n\n1. Diagnosis of secondary or atypical parkinsonism\n2. Laboratory Values:\n\n   1. Hemoglobin (Hgb) \\\u003C10\n   2. Platelets \\\u003C70,000\n   3. Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \\> 2 1\u002F2 times upper limit of normal (ULN)\n   4. Moderate or severe renal disease with an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002FBSA \\[body surface area\\]) calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, or moderate or severe hepatic impairment (alkaline phosphatase \\[ALP\\] \\>2.0 times the ULN and\u002For total bilirubin \\>2.0 times the ULN)\n   5. Significantly above the normal range for PT\u002FINR\u002FPTT\n3. Currently taking anticoagulants that are deemed exclusionary by the investigator for risk of bleeding with sigmoidoscopy procedure\n4. Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score \\\u003C22\n5. Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than PD, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Creutzfeld-Jakob- Disease, Down's syndrome, cortico-basal degeneration, dementia with Lewy Bodies, Alzheimer's disease, amyotrophic lateral sclerosis, seizure disorder, stroke, or other infectious, metabolic, or systemic disease affecting the central nervous system including, but not limited to, syphilis, present hypothyroidism, present or unaddressed\u002Ftreated vitamin B12 deficiency, or other screening laboratory abnormalities\n6. Suicidality, defined as active suicidal thoughts or ideation within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide\n7. Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated\u002Fremoved cutaneous carcinomas are not excluded.)\n8. Any medical condition or systemic disease that, in the Investigator's opinion, may either put the participant at risk because of participation in the study, influence the results or proposed analyses, or impair the participant's ability to fully participate in the study\n9. Body mass index (BMI) \\>35 kg\u002Fm2 or body weight \\\u003C50 kg\n10. Participant is currently pregnant, breastfeeding, and\u002For lactating\n11. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)\n12. History of Covid 19 (SARS-CoV-2) infection within 6 weeks prior to screening.\n13. Participants with unresolved symptoms of Covid 19 infection or ongoing cognitive or other deficits attributable to post-Covid 19 that may affect participant safety or interfere with cognitive assessments based on the Investigator's clinical judgment\n14. Either ongoing or current participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. Participation in other research studies (e.g., observational studies) may be acceptable throughout this study.\n15. History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate).\n16. Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly)\n17. Has a history of Crohn's disease, ulcerative colitis, and\u002For other types of colitis (microscopic, lymphocytic, or collagenous colitis). Confirmed diagnosis of inflammatory bowel disease (IBD) and\u002For, active or uncontrolled IBD symptoms such as diarrhea, bleeding, or severe stomach pain. Treatment for IBD in the past 6 months with medicines such as steroids, biologics, or strong immune-suppressing drugs. Surgery to remove part of the bowel due to IBD. Other long-term gut diseases that cause inflammation, such as celiac disease.",true,"ALL","21 Years","80 Years",{"count":23,"type":24},250,"ESTIMATED","OBSERVATIONAL","The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study.\n\nDuring this study, specific groups of participants, also known as \"cohorts\", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection.\n\nParticipants in this study will:\n\n* meet with a medical provider\n* answer questionnaires\n* give samples of blood, stool, and saliva\n* have X-rays taken while swallowing different foods (swallowing study)\n* have X-rays taken to see how long it takes markers to move through their colon (colon transit study)\n* have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining)\n* have samples taken of their skin\n* have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function.\n\nParticipation in the study will last up to 24 months (2 years).",[28,29,30,31,32],"Parkinson Disease (PD)","PARKINSON DISEASE (Disorder)","Gut Microbiome","Gut Microbiota","Prodromal Parkinsons Disease",[34,35,36,37],"gut brain","Parkinson's disease","Prodromal Parkinson's disease","healthy control","RECRUITING","2026-08-20",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":42},"2026-07-03",{"date":46,"type":24},"2028-12-31",{"name":48,"class":49},"Duke University","OTHER",7,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":62,"studyType":25,"phases":4,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100652778","characterization-and-validation-of-the-short-physical-performance-battery-in-individuals-diagnosed-with-parkinsons-disease-100652778","NCT07780461","Characterization and Validation of the Short Physical Performance Battery in Individuals Diagnosed With Parkinson's Disease","Observational Study for the Functional Characterization of the Population Diagnosed With Parkinson's Disease in Galicia, and Validation of the Short Physical Performance Battery in Individuals Diagnosed With Parkinson's Disease","PDSPPB","Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's disease confirmed by a neurologist.\n* Provision of written informed consent by the participant or, when applicable, by a legally authorized representative.\n\nExclusion Criteria:\n\n* Inability to complete the study assessment procedures.","18 Years",{"count":61,"type":24},350,"1 Week","Parkinson's disease (PD) is a progressive neurodegenerative disorder associated with motor and non-motor impairments that affect physical function, mobility, balance, and quality of life. Although Galicia is one of the Spanish regions with a high prevalence of PD, comprehensive information regarding the functional characteristics of this population remains limited.\n\nThis observational cross-sectional study aims to characterize the sociodemographic, clinical, cognitive, behavioral, and functional profile of individuals with Parkinson's disease in Galicia and to evaluate the validity and reliability of the Short Physical Performance Battery (SPPB) in this population. The findings will provide updated information on the functional status of people with PD in Galicia and support the use of the SPPB as a practical tool for the assessment of physical performance in clinical and research settings.",[29],[66,67,68,69,70],"Parkinson´s Disease","Physical Function","Short Physical Performance Battery (SPPB)","Functional Assessment","Psychometric Validation","2026-08-18",{"date":41,"type":42},{"date":74,"type":42},"2026-08-01",{"date":76,"type":24},"2026-12-25",{"name":78,"class":49},"University of Vigo",2,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":21,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":79},"100632792","remotely-supervised-home-based-transcranial-temporal-interference-stimulation-on-motor-symptoms-in-parkinsons-disease-100632792","NCT07518290","Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease","Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease: Protocol For a Double Blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease according to established clinical criteria\n* Mild-to-moderate disease severity, defined as Hoehn and Yahr stage 1.5-3;\n* Age between 40 and 80 years;\n* Stable anti-parkinsonian medication regimen;\n* Ability to walk unaided for at least 2 minutes.\n\nExclusion Criteria:\n\n* contraindications to TIs (e.g., metal implantation, pacemakers, etc.);\n* the use of DBS;\n* significant cognitive impairment as defined by the diagnosis of Alzheimer's disease or dementia, or Montreal Cognitive Assessment (MoCA) total score\\\u003C21, a recommended threshold for dementia in PD;\n* diagnosis of other neurological conditions such as multiple sclerosis, previous stroke;\n* report of severe lower-extremity arthritis, pain, or orthopedic problems significantly affecting gait;\n* physician-diagnosis of schizophrenia or other psychiatric illness;\n* an unwillingness to cooperate or participate in the study protocol. Eligible and interested participants will then be enrolled and complete baseline assessments before the randomization.","40 Years",{"count":89,"type":24},68,"INTERVENTIONAL",[92],"NA","The goal of this clinical trial is to learn if home-based temporal interference stimulation (TIS) works to improve motor symptoms in people with Parkinson's disease (PD). It will also learn about the safety of this treatment. The main questions it aims to answer are:\n\n1. Does home-based TIS improve movement problems such as slow movement, stiffness, and walking difficulty?\n2. Are the effects maintained after the treatment ends?\n3. What medical problems (adverse events) occur during treatment? Researchers will compare active TIS to a sham treatment (a look-alike procedure that does not deliver active stimulation) to see if TIS works.\n\nParticipants will:\n\n1. Receive active TIS or sham stimulation once a day for 4 weeks at home under remote supervision\n2. Visit the clinic at specific time points for movement assessments\n3. Complete online questionnaires about symptoms and quality of life",[29,95],"Motor Symptoms",[97,98,99,100,101],"Parkinson disease","Transcranial temporal interference stimulation","Home-based intervention","Motor symptom","Randomized controlled trial","2026-08-11",{"date":104,"type":42},"2026-08-13",{"date":106,"type":42},"2026-04-04",{"date":108,"type":24},"2028-03-30",{"name":110,"class":49},"Shanghai University of Sport",{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":90,"phases":121,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100651589","phase-3-safinamide-vs-placebo-for-pain-in-patients-with-parkinsons-disease-and-motor-fluctuations-100651589","NCT07761936","Safinamide vs Placebo for Pain in Patients With Parkinson's Disease and Motor Fluctuations","Effects of Safinamide Versus Placebo on Pain in Patients With Parkinson's Disease With Motor Fluctuations: A Randomized, Controlled, Double-Blind Clinical Trial","SAVE PAIN","Inclusion Criteria:\n\n* Age ≥ 18 years; PD-related chronic pain (lasting more than 3 months) and motor fluctuations while receiving stable doses of L-dopa (alone or with other dopaminergic treatments) for at least 4 weeks prior to baseline (visit T0).\n* Diagnosis of PD according to the International Parkinson and Movement Disorders Society (MDS) clinical diagnostic criteria.\n* Disease duration since diagnosis of ≥ 3 years.\n* Presence of motor fluctuations (\\> 1.5 hours OFF time\u002Fday excluding morning akinesia)\n* Hoehn and Yahr stage II-III during ON time.\n* A history of pain symptoms for the last 12 weeks \\[at least 4 points scored on the Numerical Rating Scale (NRS)\\].\n* Willing to participate in this study and able to understand and sign the written informed consent and the form privacy data.\n* Be responsive to levodopa as per the MDS Clinical Diagnostic Criteria for Parkinson's disease, which define responsiveness as a clinically meaningful benefit to dopaminergic therapy, either documented objectively or subjectively.\n* Be on stable daily doses of oral L-dopa (including controlled release \\[CR\\], immediate release \\[IR\\] or a combination of CR\u002FIR), with and without benserazide\u002Fcarbidopa, and optionally with a catechol-O-methyltransferase (COMT) inhibitor. Participants may also be receiving stable doses of dopamine agonists, anticholinergics and\u002For amantadine for at least 4 weeks prior to the screening visit.\n* Participants must be able to speak and understand the Italian language.\n* If female, participants must either be post-menopausal for at least one year, as self-reported by the patient, or, if of childbearing potential, must have a negative plasma human chorionic gonadotropin (HCG) test to exclude pregnancy at screening. Additionally, if of childbearing potential, patients will be required to undergo monthly urine pregnancy testing, scheduled at approximately day 30 and day 60, and the urine test at the final visit (T1). Moreover, women of childbearing potential must agree to use a highly effective method of contraception, starting 2 months before enrollment, throughout the entire duration of the study and for at least 30 days after the last dose of the study medication. Acceptable methods of contraception include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence \\[Sexual abstinence is considered an acceptable method only if it reflects the participant's consistent and preferred lifestyle.\\].\n\nExclusion Criteria:\n\n* Concomitant therapy with monoamine oxidase B inhibitors.\n* Patients experiencing severe, disabling peak-dose or biphasic dyskinesia, or unpredictable or widely swinging symptom fluctuations.\n* De novo patients.\n* Evidence of dementia suggested by a Mini-Mental Scale Examination (MMSE) score \\\u003C 24.\n* Evidence of depression according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM V.3.\n* Treatment with antidepressant medications.\n* Signs and symptoms suggestive of atypical parkinsonism.\n* Severe and progressive medical illnesses other than PD.\n* Concomitant diseases potentially causing acute or chronic pain (i.e., rheumatologic conditions, cancer, severe polyneuropathy, and spine injuries).\n* Treatment with opioids, neuroleptics, barbiturates, phenothiazines, pregabalin, gabapentin.\n* Any other contraindication according to the current Summary of product characteristics (SmPC) of safinamide.\n* Previous neurosurgical intervention or stereotactic brain surgery for PD.\n* Concomitant infusive device-aided therapies for PD.\n* Drug and\u002For alcohol abuse within 12 months prior to the screening visit.\n* Use of any investigational drug or device within 30 days prior to screening or 5 half-lives (whichever is the longest), or at any point during the study.\n* Known allergy, sensitivity, or contraindications to the investigational medicinal products (IMPs), their excipients.\n* Any clinically significant condition which, in the opinion of the Investigator, would be incompatible with study participation or pose a risk to the patient during the study.\n* Moderate to severe liver failure as defined by the Child-Pugh classification score, or human immunodeficiency virus (HIV) infection.\n* Treatment with monoamine oxidase inhibitors (MAOIs), pethidine, opiates, opioids, fluoxetine, fluvoxamine within 4 weeks prior to the screening visit. These drugs are not allowed throughout the study and up 2 weeks after the last dose of study drug.\n* History of ophthalmologic conditions including any of the following: albinism, uveitis, retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive diabetic retinopathy, inherited retinopathy or family history of hereditary retinal disease.\n* Pregnancy and breastfeeding.",{"count":120,"type":24},60,[122],"PHASE3","This is a Phase III, single-center, randomized, double-blind, placebo-controlled clinical trial designed to investigate the superiority of safinamide compared to a placebo in reducing Parkinson's Disease (PD)-related pain.\n\nThe trial plans to enroll 60 adult patients diagnosed with PD who experience motor fluctuations and chronic pain (lasting more than 3 months) despite receiving stable doses of levodopa.\n\nParticipants will be randomized in a 1:1 ratio to receive either oral safinamide or a matching placebo as an add-on therapy. The treatment regimen consists of 50 mg\u002Fday for the first week, increasing to 100 mg\u002Fday for the remaining 11 weeks, for a total treatment duration of 12 weeks.\n\nThe primary endpoint is to evaluate the mean change in pain severity from baseline to 12 weeks, measured using the 11-point Numeric Rating Scale (NRS) Secondary endpoints will assess additional qualitative and quantitative pain characteristics (KPPS, BPI, PD-PCS), motor symptoms and treatment complications (UPDRS Parts III and IV, Home Diary), quality of life (PDQ-39), and other non-motor symptoms (MDS-NMS).\n\nThe total expected duration of the clinical trial is 24 months.",[29,125,126,28],"Pain","Pain Management","2026-08-07",{"date":104,"type":42},{"date":130,"type":42},"2026-04-28",{"date":132,"type":24},"2027-12",{"name":134,"class":49},"Universita di Verona",1,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":18,"sex":19,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":153,"leadSponsor":155,"locationsCount":135},"100650540","gut-microbiota-and-tryptophan-metabolites-in-parkinsons-disease-100650540","NCT07749261","Gut Microbiota and Tryptophan Metabolites in Parkinson's Disease","An Exploratory Case-Control Study of Fecal Microbiota and Targeted Tryptophan Metabolite Profiling in Patients With Parkinson's Disease","Inclusion Criteria:\n\n* Participants aged 45 to 90 years, of any sex. Participants able to understand the study, provide written informed consent, and provide an acceptable stool sample according to the study procedures.\n\nFor the Parkinson disease group: clinically established or clinically probable Parkinson disease diagnosed by a neurologist according to the Movement Disorder Society Clinical Diagnostic Criteria.\n\nFor the Parkinson disease group: preferably a disease duration of 5 years or less and Hoehn-Yahr stage I to III.\n\nFor the Parkinson disease group: stable antiparkinsonian medication regimen for at least 4 weeks before enrollment.\n\nFor the healthy control group: no history of Parkinson disease, parkinsonism, or another neurodegenerative disorder and no evident parkinsonian symptoms at screening.\n\nHealthy controls matched individually to participants with Parkinson disease by sex, age within 5 years, and body mass index within 3 kg\u002Fm\\^2\n\nExclusion Criteria:\n\n* Use of systemic antibiotics within 3 months before stool collection. Use of probiotics, prebiotics, tryptophan, 5-hydroxytryptophan, live biotherapeutic products, or other microbiome-related supplements within 4 weeks before stool collection.\n\nAcute infection, fever, acute diarrhea, gastroenteritis, colonoscopy preparation, or a major dietary change within 4 weeks before stool collection.\n\nActive inflammatory bowel disease, celiac disease, short-bowel syndrome, gastrointestinal malignancy, or major gastrointestinal surgery within 6 months.\n\nActive cancer, decompensated liver or kidney disease, severe cardiovascular or hematological disease, active autoimmune disease, or current systemic glucocorticoid or immunosuppressive treatment.\n\nPregnancy or breastfeeding. Long-term exclusive enteral or parenteral nutrition. Inability to provide an acceptable stool sample or essential clinical information.\n\nAny other condition considered by the investigator to compromise participant safety, study adherence, or interpretation of the results.","45 Years","90 Years",{"count":146,"type":24},30,"Parkinson's disease is a progressive neurological disorder that can also affect the digestive system. Changes in gut microorganisms and tryptophan metabolites may be associated with Parkinson's disease, but these relationships are not fully understood. This exploratory observational study will compare gut microbial communities and targeted tryptophan metabolite profiles between 15 participants with Parkinson's disease and 15 healthy controls matched by sex, age, and body mass index.\n\nEach participant will provide clinical and lifestyle information and one stool sample. Stool samples will be analyzed using 16S ribosomal RNA gene sequencing and targeted liquid chromatography-tandem mass spectrometry. The study will evaluate differences in gut microbial composition and selected tryptophan metabolites and explore their associations with constipation, bowel habits, medication use, and clinical features of Parkinson's disease. No treatment will be assigned, and participants' usual medical care will not be changed. The findings are exploratory and are intended to guide larger future studies; they cannot establish causality or be used to diagnose Parkinson's disease.",[29],"NOT_YET_RECRUITING",{"date":151,"type":42},"2026-08-06",{"date":39,"type":24},{"date":154,"type":24},"2026-11-20",{"name":156,"class":49},"Ningxia Medical University",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":19,"minAge":143,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":90,"phases":168,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":185},"100609501","phase-2-prescriptive-infusion-algorithm-pia-100609501","NCT07215403","Prescriptive Infusion Algorithm (PIA)","Open-Label, Multi-Stage Study to Optimize the Intraputaminal Administration of AB-1005 Using a Prescriptive Infusion Algorithm (PIA)","PIA","Inclusion Criteria:\n\n* Participant must be 45 to 75 years of age inclusive, at the time of signing the informed consent.\n* \\>10 years since diagnosis of PD (at time of consenting \u002F Screening Visit 1)\n* Presence of bradykinesia plus any of the following:\n* Rigidity\n* Resting tremor\n* Postural instability\n* Modified Hoehn and Yahr stage III-IV in the practically defined OFF state\n* Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score \\>40 in the practically defined OFF state\n* Stable anti-PD medication regimen for at least 4 weeks prior to Screening Visit 1 and through Baseline Visit\n* ≥30% reduction in MDS-UPDRS Part III following a levodopa challenge\n* Must agree to use barrier method protection when engaging in intercourse\u002Fsexual activity with another person for at least 3 months post-dosing.\n* Male participants must refrain from donating sperm for at least 3 months post-dosing.\n* Female participants cannot be pregnant or breastfeeding at the time of screening. A woman of childbearing potential (WOCBP) must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at the required assessments\n* Provision of signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n* Provision of signed consent to also participate in LTFU study ASK-PD0-CS002\n\nExclusion Criteria:\n\n* Evidence of secondary or atypical parkinsonism (as determined by the neurologist)\n* Presence or history of psychosis or impulse control disorder (as determined by the neurologist)\n* Presence or history (within 2 years prior to screening) of substance use disorder (including alcohol) as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria (or in the judgment of the neurologist)\n* Presence of untreated or sub optimally treated depression (Beck Depression Inventory \\[BDI\\]-II score ≥20)\n* Current suicidal ideation as indicated by positive response to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C SSRS), or any history of a suicide attempt\n* Clinically significant cognitive impairment (Montreal Cognitive Assessment \\[MoCA\\] score \\\u003C25)\n* Presence or history of malignancy other than treated cutaneous squamous or basal cell carcinomas\n* Presence of clinically active infection, including acute or chronic scalp infection\n* Known contraindications to MRI\n* Presence or history of significant cerebrovascular or cardiovascular disease, including:\n* Stroke, transient ischemic attack, or other suspected cerebrovascular accident within 1 year prior to screening\n* Unstable angina pectoris or myocardial infarction within 1 year prior to screening\n* Revascularization procedure(s) within 1 year prior to screening\n* Poorly controlled hypertension, poorly controlled diabetes mellitus or prediabetes mellitus with known significant microvascular injury, or other significant cardiovascular history or risk factor\n* Known history of complications of anesthesia including difficult airway management and\u002For difficult endotracheal intubation, malignant hyperthermia, or other related issues that would compromise participant safety during general anesthesia (as determined by the anesthesiologist)\n* Inability to identify a safe trajectory to each putamen via an occipitoparietal entry point, or known contraindications to brain surgery in prone position (as determined by the neurosurgeon)\n* Known allergy or sensitivity to ingredients in the intervention formulation and\u002For to gadolinium-based contrast agents\n* Concurrent use of percutaneous levodopa\u002Fcarbidopa intestinal gel, subcutaneous levodopa, or apomorphine pump\n* History of brain surgery (including deep brain stimulation \\[DBS\\] or focused ultrasound)\n* Chronic immunosuppressive therapy\n* History of prior cell or gene therapy\n* Participation in other interventional clinical trials within 12 weeks prior to screening or unwilling to refrain from starting new investigational agents throughout the course of the study\n* Laboratory values at screening:\n* Platelets ≤100,000\u002Fmm3\n* PT \\>15 s, aPTT \\>40 s, and\u002For INR \\>1.3\n* Absolute neutrophil count (ANC) ≤1500\u002Fmm3\n* Hemoglobin ≤10.0 g\u002FdL\n* Aspartate aminotransferase or alanine aminotransferase ≥2.5 times the upper limit of normal\n* Total bilirubin ≥2.5 mg\u002FdL\n* eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2\n* HbA1C ≥8%\n* Unable to comply with the protocol procedures, including frequent and prolonged follow-up assessments (during LTFU study ASK-PD0-CS002)\n* Unwilling to defer any vaccination from screening through 1 month after surgery\n* Any significant issue raised by the neurologist, neurosurgeon, or anesthesiologist that may make a participant unsuitable for the study","75 Years",{"count":167,"type":24},18,[169],"PHASE2","This study is being done to test a new way of delivering AB-1005 into the brain. The goal is to make the procedure easier and quicker to perform, while providing similar amounts of drug to the part of the brain that needs treatment.\n\nTechnical (Stage 0) To test if the new delivery method (prefrontal surgical approach) can consistently deliver AB-1005 to the putamen using MRI monitoring.\n\nTechnical (Stage 1) To test if the new delivery method (PIA-based infusion) can consistently deliver AB-1005 to the putamen using brain imaging by MRI.\n\nTechnical (Stage 2) To confirm the new delivery method works without brain imaging by MRI, using standard operating room tools including brain imaging by CT.\n\nSafety (Stage 1 and 2) To assess the safety and tolerability of the new delivery method for AB-1005 up to 6 months after surgery",[29],[173,174],"PD","Parkinsons Disease","2026-07-24",{"date":177,"type":42},"2026-07-27",{"date":179,"type":24},"2026-11",{"date":181,"type":24},"2028-11-01",{"name":183,"class":184},"AskBio Inc","INDUSTRY",4,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":19,"minAge":143,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":90,"phases":196,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100645663","effect-of-hand-rehabilitation-on-cognitive-function-in-patients-with-pd-100645663","NCT07702929","Effect of Hand Rehabilitation on Cognitive Function in Patients With PD","Effect of Sensory-motor Rehabilitation of the Hand on Cognitive Functions in Patients With Parkinson's Disease","Inclusion Criteria:\n\n1. A diagnosis of PD by a neurologist based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease;\n2. 45-65 years old: age of peak incidence of PD;\n3. Minimum 2 years and maximum 10 years from initial diagnosis: stabilization of the disease process and medications;\n4. disability level of at most 3 in the Modified Hoehn and Yahr Scale: physically independent;\n5. Mild cognitive impairment: score between 20 and 26 in Montreal cognitive assessment;\n6. Signing the written informed consent.\n\nExclusion Criteria:\n\n1. Patients with neurological diseases other than PD\n2. Patients with orthopedic and internal diseases that would make participation in the study difficult","65 Years",{"count":195,"type":24},48,[92],"Evidence suggests the association between fine motor skills of the hand and cognitive function, as well as the positive effects of hand rehabilitation on hand function and the effectiveness of cognitive rehabilitation on cognitive functions in patients with Parkinson's disease (PD). In response to the question of whether there is a cause-and-effect relationship between fine manual skills and cognitive function, we designed the present randomized controlled trial to investigate the effectiveness of sensory-motor rehabilitation of the hand on cognitive functions compared to the effectiveness of cognitive rehabilitation on sensory-motor skills of the hand in patients with PD.\n\nIn this double-blinded, randomized controlled trial, a convenience sample including 48 people with PD will participate based on simple non-random sampling. The participants will be allocated randomly through stratified randomization to parallel groups of intervention (sensorimotor hand rehabilitation) and control (cognitive rehabilitation) with a 1:1 allocation ratio. The associate researcher responsible for assessing outcome measures and the statistician responsible for analyzing the data are blinded to the intervention protocol. The intervention protocol for the intervention group includes hand sensory-motor rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week, in addition to cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week. The intervention protocol for the control group includes cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week. All participants undergo three assessment sessions: the day before the intervention, the day after the intervention, and one month after the last intervention session. Data will be analyzed using SPSS version 22.0. The significance level will be set at 0.05.",[29],[200,201,202,203,204],"Cognition","Hand Function","Parkinson's Disease","Occupational Therapy","Rehabilitation","2026-07-23",{"date":175,"type":42},{"date":208,"type":24},"2026-08-23",{"date":210,"type":24},"2027-11-23",{"name":212,"class":49},"Isfahan University of Medical Sciences",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":19,"minAge":219,"maxAge":21,"enrollmentInfo":220,"targetDuration":4,"studyType":90,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":231,"leadSponsor":233,"locationsCount":135},"100648717","investigating-the-increased-risk-of-falls-in-individuals-with-parkinsons-disease-treated-with-deep-brain-stimulation-100648717","NCT07725315","Investigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation","Inclusion Criteria:\n\n* Age between 30-80, patient has elected to undergo DBS surgery as part of routine care, cleared for deep brain stimulation surgery as part of routine care by the movement disorders committee. Refractory motor symptoms such as dyskinesias, wearing off, and\u002For motor fluctuations, causing significant disability, despite reasonable attempts at medical management, as determined by the consensus DBS committee, able to walk, Patient is available for follow-up over the length of the study\n\nExclusion Criteria: Patient's insurance will not cover the costs of surgery with investigational devices, Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation, self-report of lack of clear levodopa response, requires a walker or wheelchair for mobility\n\n\\-","30 Years",{"count":221,"type":24},20,[92],"The purpose of this pilot study is to assess changes in thinking and movement after deep brain stimulator implantation. The study will also examine whether these changes are related to the risk of falls.",[225,29],"Deep Brain Stimulation",[227],"DBS, Parkinson's disease, Falls","2026-07-21",{"date":175,"type":42},{"date":74,"type":24},{"date":232,"type":24},"2027-11-01",{"name":234,"class":49},"University of Alabama at Birmingham",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":19,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":90,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":135},"100607580","multicontext-approach-for-cognitive-function-in-parkinson-disease-100607580","NCT07190404","Multicontext Approach for Cognitive Function in Parkinson Disease","Efficacy and Mechanisms of a Metacognitive Strategy Intervention for Parkinson Disease-Related Cognitive Decline.","MC4PD R01","Inclusion criteria:\n\n1. Males and females over age 50 who meet criteria for typical idiopathic PD.\n2. Hoehn \\& Yahr stage I-III.\n3. Have subjective cognitive decline (SCD) as defined by a positive answer to either question:\n\n   * Do you feel like your thinking skills or memory are becoming worse or are worse than others your age?\n   * Do you have problems or concerns with your thinking skills or memory?, and can list ≥1 daily cognitive challenge they want to address.\n4. Medications should be stable for 4 weeks prior with no changes planned during the treatment portion of the study (Pre to Post); unplanned changes and changes over the follow-up period will be tracked and accounted for as appropriate.\n\nExclusion criteria:\n\n1. Dementia according to MDS criteria or MoCA score \\\u003C21.\n2. Other neurological disorders (e.g., stroke, seizures).\n3. Current or history of major psychiatric disorder or psychotic symptoms (e.g., schizophrenia, bipolar disorder, delusions, hallucinations), drug abuse. Psychiatric conditions\u002Fsymptoms that are common in PD (e.g., anxiety, depression) are permitted if deemed insufficient to interfere with participation.\n4. Other circumstance that would interfere with participation (e.g., non-English speaking, blindness, lives \\>50mi away).","50 Years",{"count":245,"type":24},114,[92],"Mild cognitive decline is common in early Parkinson disease (PD) and is associated with disability, reduced quality of life (QOL), and increased risk for dementia. Medical treatments for PD do not prevent or treat cognitive decline and may even exacerbate the problem.\n\nUnfortunately, existing cognitive interventions for PD, which focus on restoring deficient cognitive skills through cognitive training (repetitive practice of tasks that challenge specific cognitive skills), provide limited benefit for daily function and QOL. To overcome this limitation, the investigators use strategy training. the investigators help people develop targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish daily activities. Contemporary cognitive rehabilitation evidence supports strategy training for other neurological conditions and mild cognitive impairment (MCI), but it has not been well-studied in PD. By teaching strategies for everyday cognition, the investigators hypothesize that our interventions will improve functional outcomes for people with PD.\n\nStudy participants will complete a baseline cognitive testing session, 10 cognitive treatment sessions with a trained occupational therapist, then have follow-up visits with the study team at 1-week, 3-months, 6-months, and 12-months after completing the study intervention.",[29],[250,251],"Parkinson Disease","occupational therapy","2026-07-13",{"date":254,"type":42},"2026-07-14",{"date":256,"type":42},"2026-05-20",{"date":258,"type":24},"2030-08-31",{"name":260,"class":49},"Washington University School of Medicine",{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":165,"enrollmentInfo":268,"targetDuration":4,"studyType":90,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":135},"100607803","mental-imagery-on-upper-extremity-skills-100607803","NCT07193303","Mental Imagery on Upper Extremity Skills","The Immediate Effect of Mental Imagery on Upper Extremity Skills With the Patients of Parkinson's Disease","Inclusion Criteria:\n\n* Healthy individuals aged 40-75 years, diagnosed with idiopathic PD according to the UK Parkinson's Disease Association Brain Bank criteria by a specialist neurologist, with a Modified Hoehn \\& Yahr (m-HY) scale stage ≤4, and with a Mini Mental State Examination score of ≥24 for those with training and ≥18 for those without training, and with no known disease, volunteered to participate in the study.\n* PD individuals with no other known neurological and\u002For systemic disease\n* PD individuals without any upper extremity contractures\n\nExclusion Criteria:\n\n* Individuals with diagnosed and\u002For treated psychiatric illnesses who are considered unable to complete the tests.\n* Individuals who is taking neuroleptic medications or antidepressants.\n* Individuals with orthopedic conditions that interfere with manual dexterity tests, such as severe dyskinesia, carpal tunnel syndrome, tendon injuries, or finger amputations; rheumatological conditions such as rheumatoid arthritis and osteoarthritis; and individuals with any neurological condition other than PD.",{"count":146,"type":24},[92],"Parkinson's disease (PD) is the second most common neurodegenerative disease, characterized pathologically by the progressive loss of dopaminergic neurons in the substantia nigra and clinically by the presence of motor symptoms such as bradykinesia, resting tremor, and\u002For rigidity. Among the motor deficits frequently observed in PD, patients are known to frequently report difficulties with manual dexterity. Many upper extremity and manual dexterity deficits are present in PD. Motor imagery (MI) is the imaginal execution of motor activities or the activation of specific muscles in the absence of any explicit feedback. This area of rehabilitation has been shown to be effective in improving and developing motor skills in many neurological conditions where patients exhibit motor recognition and execution impairments. MI can be applied at all stages of recovery from PD, is highly effective in movement-related pathologies, and can be performed independently.There is sufficient evidence that MI improves motor performance and learning in individuals with neurological disorders such as multiple sclerosis, stroke, and spinal cord injury. The study was designed to investigate the immediate effects of mental imagery, which is thought to be effective in controlling difficulties in planning and initiating movements in PD, on upper extremity skills. Therefore, the aim of this study was to determine the effect of mental imagery on upper extremity skills in PD.",[29,272,273],"Mental Imagery","Motor Imagery","2026-07-12",{"date":254,"type":42},{"date":277,"type":42},"2026-05-15",{"date":279,"type":24},"2027-01-30",{"name":281,"class":49},"Kahramanmaras Sutcu Imam University",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":165,"enrollmentInfo":289,"targetDuration":4,"studyType":90,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":50},"100604581","phase-3-intestinal-levodopa--entacapone-therapy-lecigon-to-counteract-dopaminergic-desensitization-and-neuropsychiatric-complications-in-parkinsons-disease-100604581","NCT07151378","Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease","INITIATE-LECIG","Inclusion Criteria:\n\n* Understand and voluntarily sign an informed consent document prior to any study related assessments\u002Fprocedures. 2. Able to adhere to the study visit schedule and other protocol requirements. 3. Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during the study (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner2, sexual abstinence3).\n\n  1. For the purpose of this document, a female is considered of childbearing potential (FCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. For the purpose of this document, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy\n  2. Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success\n  3. In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. 4. All subjects must agree not to share medication. 5. Diagnosis of Idiopathic PD, inclusive of familial PD and genetic forms of L-Dopa responsive PD Age 18 - 75 years 7. Age at Parkinson's disease onset before 65 years 8. Disease duration ≥ 5 years 9. Oral medication constant for four weeks prior to baseline visit 10. Oral treatment with L-Dopa and non-ergot dopamine agonist(s) (any preparation, any dosage) 11. Presence of dopaminergic motor fluctuations based on patient history 12. Presence of dopaminergic neuropsychiatric (affective) fluctuations based on patient history 13. Presence of behavioural hyperdopaminergic syndrome including clinically relevant neuropsychiatric behavioural abnormalities according Ardouin Behavioural Scale Section 1, hypomanic symptoms, psychosis + Section 4 hyperdopaminergic behaviours (score ≥ 3), eventually further accompanied by impulse control disorders, a\u002Fo dopamine dysregulation, syndrome, a\u002Fo hallucination - psychosis spectrum; in case symptoms of the hallucination\u002Fpsychosis or hypomania-mania spectrum are present, retained insight is mandatory at the time of study enrolment\n\nExclusion Criteria:\n\n* 1.Women during pregnancy and lactation. 2. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. 3. Participation in other clinical trials or observation period of competing trials over the past three months 4. Patients suffering from cognitive impairment (MoCA \\\u003C 21) will be excluded for the major reason to obtain valid Ardouin assessments that will be hampered in case cognitive impairment (and therefore insight) is too severe 5. Acute paranoid psychosis without retained insight (however impulse control disorder or dopamine dysregulation syndrome are not an exclusion criterion; illusions or (pseudo)-hallucinations are not an exclusion criterion as long as there is no endangerment of the patients themselves or other persons owing to clinical judgement; patients may be eligible after remission of psychosis\u002Fsuicidality) 6. Severe depression according to ICD-10 criteria; however, affective fluctuations with intermittent depressive symptoms (reversed by dopaminergic medication) are not an exclusion criterion 7. Active suicidality without self-distancing (however, suicidal ideation\u002Fthoughts or passive wishes of being dead are not an exclusion criterion as long as the patient is credibly distancing from it). 8. General contraindications for intestinal L-Dopa therapy (according to Lecigon® Fachinformation) 9. Gastrointestinal contraindications against PEG-J tube placement 10. Tremor-dominant PD without dopaminergic response fluctuationt Pre-existing device assisted therapy (DAT) immediately before study enrolment including with DBS, LCIG\u002FLECIG, or subcutaneous therapy with apomorphine or foslevodopa; if patient terminated pre-existing subcutaneous therapy, the patient will be eligible after having received oral dopamine replacement therapy for at least 3 months 12. Malignancy in a non-remitted stage",{"count":290,"type":24},150,[122],"This study is a Phase III multicentric randomized controlled trial with parallel group design and waiting list in patients that have an indication to undergo intestinal L-Dopa + entacapone (Lecigon®) under the existing indication criteria (according to SmPC (Fachinformation) Lecigon®). As primary endpoint, we will analyze the difference of the pre-interventional baseline and 6-month follow-up on the \"hyperdopaminergic symptoms\" corresponding to section 3 of the \"Ardouin Behavioural Scale\" hypothesizing on the superiority of LECIG therapy compared to best medical treatment.",[29],[295,296,297,298,299,300,301,302,303],"LECIG","device assisted therapy","motor and non-motor fluctuations","dopaminergic complications","impulse control disorder","levodopa seeking","dopamine dysregulation syndrom","dopamine agonist","intestinal levodopa","2026-07-10",{"date":252,"type":42},{"date":307,"type":42},"2025-10-27",{"date":309,"type":24},"2030-09-22",{"name":311,"class":49},"University Hospital Tuebingen",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":19,"minAge":319,"maxAge":144,"enrollmentInfo":320,"targetDuration":4,"studyType":90,"phases":322,"briefSummary":323,"conditions":324,"keywords":325,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":135},"100620345","swallowfit-study-in-parkinsons-disease-100620345","NCT07356414","SwallowFIT Study in Parkinson's Disease","\"SwallowFit,\" an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.","Inclusion Criteria:\n\n1. Adult S-VWP between \\>35-90 years of age\n2. Diagnosis of Idiopathic Parkinson's Disease \\[IDP\\] (either or suspected, tremor-predominant or rigid predominant)\n3. Disability level of Hoehn \\& Yahr stages II-III as indicated in their most recent neurological evaluation\n4. Swallowing concern, confirmed by Modified Unified Parkinson Disease Rating Scale \\[MDS-UPDRS\\]-\n5. ADL swallowing item \\>0, or Mann Assessment of Swallowing scale \\[MASA\\] score ≤185.\n6. Able to consume oral nutrition \\[Functional Oral Intake Score ≤ 6\\]\n7. Ambulatory\n8. No change of medication for at least 4 weeks before study inclusion\n\nExclusion Criteria:\n\n1. Classified as Hoehn and Yahr stages IV\n2. Unable to follow 2 step commands\n3. History of other neurological disease potentially causing dysphagia\n4. Dementia (MMSE\\\u003C20; Montreal cognitive assessment (MoCA) ≤ 20)\n5. Severe depression (BDI\\>19)\n6. Severe dyskinesia of head and neck (resulting in problems with MBSS recording)\n7. Severe documented Gastrointestinal disease\n8. History of Gastro-esophageal surgery\n9. History of Head or neck cancer with swallowing impairment or surgical intervention\n10. History of breathing disorders or diseases (e.g., Asthma, chronic obstructive pulmonary disease (COPD) requiring assistive breathing support.\n11. Untreated hypertension\n12. Heart disease requiring restricted activity and medical intervention\n13. Speech therapy intervention for swallowing within the past three months\n14. Women who are pregnant, nursing, or who plan to become pregnant during the study","35 Years",{"count":321,"type":24},80,[92],"The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease.\n\nThe aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study.\n\nPatients who are given the exercise training will be compared to participants who are treated using the usual standard treatment.\n\nPatients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.",[29],[326,327,328,329],"Swallowing","US Service members","Veterans","SwallowFIT","2026-07-09",{"date":252,"type":42},{"date":333,"type":24},"2026-08-30",{"date":335,"type":24},"2028-06-29",{"name":337,"class":49},"The University of Texas Health Science Center at San Antonio",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":90,"phases":346,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":135},"100600190","protocol-of-the-packer-managing-fatigue-program-versus-standard-information-to-improve-energy-conservation-self-efficacy-in-parkinsons-disease-100600190","NCT07094269","Protocol of the Packer Managing Fatigue Program Versus Standard Information to Improve Energy Conservation Self-Efficacy in Parkinson's Disease","Protocol for a Superiority Randomized Controlled Trial of a Group-Based Fatigue Management Program Versus Standard Information to Improve Self-Efficacy in Energy Conservation in Parkinson's Disease","Inclusion Criteria:\n\n* aged \\>18 years\n* diagnosis of idiopathic Parkinson's disease (PD)\n* Hoehn and Yahr stage ≤3.5\n* Fatigue Severity Scale (FSS) \\>= 4\n\nExclusion Criteria:\n\n* Montreal Cognitive Assessment (MoCA) score \\\u003C22\n* comorbid medical conditions that could independently contribute to fatigue\n* not being fluent in the Italian language\n* Parkinsonism",{"count":321,"type":24},[92],"This protocol describes a randomized, controlled, parallel-group, trial evaluating the effectiveness of a group-based fatigue management program for people with Parkinson's disease. The study will be conducted in Italy, with participant recruitment planned to begin on July 1st, 2025. The primary sponsor is the Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health (DINOGMI) at the University of Genoa, Italy. No external sources of monetary or material support have been declared. The study has received ethical approval from the University of Genoa's Research Ethics Committee (Comitato Etico per la Ricerca di Ateneo - CERA), under protocol number 2025.36, approved on April 3rd, 2025.\n\nThe scientific title of the trial is: Protocol for a Superiority Randomized Controlled Trial of a Group-Based Fatigue Management Program Versus Standard Information to Improve Self-Efficacy in Energy Conservation in Parkinson's Disease\". The public title is: \"Energy Matters: A Protocol of a Randomized Controlled Trial of a Group-Based Fatigue Management Program for People with Parkinson's Disease\".\n\nThe study targets individuals diagnosed with idiopathic Parkinson's disease, experiencing fatigue. Eligible participants must be over 18 years old, present with Hoehn and Yahr stage ≤3.5, and score ≥4 on the Fatigue Severity Scale (FSS). Exclusion criteria include a Montreal Cognitive Assessment (MOCA) score below 22, presence of severe psychiatric comorbidities, medical conditions contributing independently to fatigue, inability to participate in group sessions, or involvement in other structured fatigue management programs.\n\nParticipants will be randomly allocated to one of two arms. The intervention group will attend a six-week Packer Managing Fatigue Program1 Sessions will be conducted in groups of 8-10 participants, led by a licensed occupational therapist. Topics covered include rest, communication, body mechanics, ergonomics, energy-conserving tools, prioritization, lifestyle balance, and goal setting. Sessions will use standardized materials such as participant workbooks2 and visual aids and will take place in appropriately equipped rooms. If a participant is absent from a scheduled group session for personal reasons, the occupational therapist will organize an individual make-up session before the next scheduled group session. This individual session will follow the same content and structure as the missed group session, based on the Packer Managing Fatigue Program. Its purpose is to ensure continuity and fidelity to the intervention, and to allow participants to stay aligned with the group program.\n\nParticipants in the control group will be provided with six fact sheets addressing general information about Parkinson's disease and fatigue.\n\nThe primary outcome is the change in self-efficacy for performing energy conservation strategies, measured using the Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA), assessed at baseline, post-intervention, and at a 3-month follow-up.\n\nSecondary outcomes include measures of motor and non-motor symptoms (Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II), fatigue severity (Fatigue Severity Scale, Parkinson Fatigue Scale), Fatigue Impact (Modified Fatigue Impact Scale), quality of life (Parkinson Disease Questionnaire-39), participation and autonomy (Impact on Participation and Autonomy questionnaire), psychiatric symptoms (Hospital Anxiety and Depression Scale), occupational balance (Occupational Balance Questionnaire-11) and sleep disturbance (Pittsburgh Sleep Quality Index - PSQI). All outcomes will be reassessed immediately and 3 months after the end of the intervention.\n\nThe total planned sample size is 74 participants, with 37 individuals in each study arm.\n\nFor public queries, the contact person is Dr. Elisa Pelosin, Associate Professor at DINOGMI, University of Genoa (email: elisa.pelosin@unige.it). For scientific queries, the reference contact is the University of Genoa's Ethics Committee (email: presidente.cera@unige.it).\n\nAn individual participant data sharing plan is in place. As part of the informed consent process, participants will be asked whether they agree to allow their anonymized data to be shared for future research purposes. Only data from participants who provide explicit consent will be shared. Anonymized individual data will be made available upon reasonable request, in accordance with institutional policies and data protection regulations. Access will be granted by the corresponding author after publication and will remain open for five years",[29],[251,350,351,352],"fatigue","parkinson's disease","self-management","2026-07-04",{"date":355,"type":42},"2026-07-08",{"date":357,"type":42},"2025-07-01",{"date":359,"type":24},"2026-09-01",{"name":361,"class":49},"Universita degli Studi di Genova",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":18,"sex":19,"minAge":87,"maxAge":21,"enrollmentInfo":368,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":135},"100645144","integrated-digital-and-neurogenic-exosome-biomarkers-for-early-diagnosis-of-parkinsons-disease-development-and-application-100645144","NCT07679256","Integrated Digital and Neurogenic Exosome Biomarkers for Early Diagnosis of Parkinson's Disease: Development and Application","Inclusion Criteria:\n\n* 1\\. Healthy Control Group\n\n  1. No severe mental illness;\n  2. Mini-Mental State Examination (MMSE) score \\>24 points; 2. Prodromal PD Group\n\n  \u003C!-- -->\n\n  1. Meets the diagnostic criteria for rapid eye movement sleep behavior disorder;\n  2. Has no severe mental disorders;\n  3. Mini-Mental State Examination (MMSE) score is greater than 24 points. 3. Early PD Group\n\n  (1) Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria ; (3) Hoehn-Yahr (H-Y) stage \\\u003C=2.0 during off-medication periods; (4) Mini-Mental State Examination (MMSE) score \\>24 points;\n\nExclusion Criteria:\n\n1. Presence of mental, cognitive, or psychological disorders, unable to sign informed consent;\n2. Presence of other diseases affecting walking distance, such as lower limb joint lesions, spinal lesions, neurological disorders, or severe cardiopulmonary diseases;\n3. Presence of intracranial structural changes, cerebrovascular disease, or other neurological disorders;\n4. Presence of tumors, severe liver or kidney dysfunction (indicators exceeding three times the normal value), or other conditions that significantly impact health;\n5. Claustrophobia or presence of implants affecting MRI scanning.",{"count":369,"type":24},700,"Based on the high-quality Parkinson's disease cohort population and biological sample database in the early stage of the team, multi-dimensional intelligent wearable device technology and machine learning were used to screen and classify digital biomarkers in the prodromal PD cohort, early PD cohort and healthy population cohort. Using peptide nanoprobes, metabolomics and Simoa technology to find the pathological molecular biomarkers of high-purity blood neurogenic exosomes in the prodromal stage of PD cohort, early PD cohort and healthy population cohort, and conduct classification and combination study. The association analysis was used to explore the specific internal relationship between digital biomarkers and neurogenic exosome molecular biomarkers, to explore the potential relationship between the two types of biomarkers, and to further apply machine learning methods to establish a fusion model for early diagnosis of PD including markers related to digital phenotype and pathological molecular mechanism, and to verify it clinically. The research results of this project are expected to bring new strategies for the early diagnosis of PD biomarkers, provide theoretical support for clinical transformation, and have important clinical significance for achieving the goal of early diagnosis and early treatment.",[29],"2026-06-25",{"date":374,"type":42},"2026-07-01",{"date":376,"type":42},"2024-01-01",{"date":378,"type":24},"2027-12-31",{"name":380,"class":49},"Fujian Medical University Union Hospital",{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":19,"minAge":243,"maxAge":144,"enrollmentInfo":387,"targetDuration":4,"studyType":90,"phases":388,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":402,"leadSponsor":404,"locationsCount":135},"100634031","treatment-of-cognitive-and-sensorimotor-deficits-in-parkinsons-disease-with-high-definition-transcranial-direct-current-stimulation-100634031","NCT07534397","Treatment of Cognitive and Sensorimotor Deficits in Parkinson's Disease With High Definition Transcranial Direct Current Stimulation","Inclusion Criteria:\n\n* Diagnosed with PD having a verbal fluency deficit based on neuropsychological test (T-score \\\u003C 40 or a T-score \\\u003C-1.0 SD below the average T-score): Semantic Object Retrieval Test (SORT), COWAT (both letter and category fluency), Boston Naming Test (BNT), Rey Auditory Verbal Learning Test (RAVLT)\n* 50 - 90 years old\n* Capable of understanding and signing an informed consent (able to answer consent comprehension questions)\n* Fluent in speaking and reading English\n\nExclusion Criteria:\n\nA potentially study-confounding, tDCS-contraindicated, or EEG-contraindicated psychological, neuropsychiatric, neurological, or other medical issues:\n\n* Montreal Cognitve Assessment (MOCA) score \\\u003C23, unless an accompanying study partner\u002Fcaregiver is with them and we can obtain the written consent of both the participant and the participant's accompanying study partner\u002Fcaregiver (i.e., the participant's spouse, adult child, parent, or adult sibling);\n* history of seizures;\n* unexplained episodes of loss of consciousness (as these may be related to brain alterations or epilepsy);\n* suffering from severe or frequent headaches;\n* unstable or uncontrolled neuropsychiatric illness;\n* severe traumatic brain injury (based on the Ohio State TBI Identification; Method);\n* brain tumor; stroke; present drug abuse\u002Fmisuse;\n* brain tumor;\n* serious or life-threatening diseases, including congestive heart failure, chronic obstructive pulmonary disease, or active malignancy;\n* Huntington's disease;\n* stroke;\n* cranial implants or skull defects that affect tDCS administration;\n* implanted brain medical devices, including, deep brain stimulators (DBS);\n* implanted pacemakers;\n* any electrically, magnetically, or mechanically activated implants;\n* cardiac, neural, or medication implants;\n* vascular clips or other electrically sensitive support systems in the brain;\n* damaged skin at the sites of stimulation (the device should only be used on healthy, intact skin, as wounds may alter resistance to current);\n* skin conditions such as dermatitis, psoriasis, or eczema;\n* pregnant women;\n* diagnosis of just dysarthria;\n\nUse of medications that interact with or potentially interact with tDCS or EEG effects:\n\n* anti-convulsants;\n* carbamazepine;\n* sulpiride;\n* pergolide;\n* lorazepam;\n* rivastigmine;\n* dextromethorphan;\n* D-cycloserine;\n* flunarizine;\n* ropinirole;\n* citalopram;\n* stimulants;\n\nAdditionally, non-English speakers will be excluded because not all of the screening forms, questionnaires, and tests are available in languages other than English.",{"count":221,"type":24},[92],"The purpose of this research study is to examine the effects of transcranial Direct Current Stimulation (tDCS) on verbal retrieval and cognition and sensorimotor control and to determine if tDCS can be used as a way to improve retrieval, sensory, and motor abilities in individuals with Parkinson's disease (PD).",[29],[392,202,393,394,395,396,397],"transcranial direct current stimulation (tDCS)","electroencephalography (EEG)","presupplementary motor area (preSMA)","verbal memory","speech sequencing","motor sequencing","2026-06-24",{"date":400,"type":42},"2026-06-26",{"date":74,"type":24},{"date":403,"type":24},"2027-10-31",{"name":405,"class":49},"The University of Texas at Dallas",{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":21,"enrollmentInfo":413,"targetDuration":4,"studyType":90,"phases":415,"briefSummary":416,"conditions":417,"keywords":423,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":4},"100641553","cognitive-based-balance-rehabilitation-in-parkinsons-disease-virtual-reality-vs-dual-task-100641553","NCT07660978","Cognitive-Based Balance Rehabilitation in Parkinson's Disease: Virtual Reality vs. Dual Task","Effects of Cognitive-Based Balance Rehabilitation on Balance, Gait and Cognitive Functions in Parkinson's Disease Patients: Comparison of Virtual Reality and Dual Task","Inclusion Criteria:\n\n* Diagnosed with Parkinson's Disease by a neurologist.\n* Hoehn \\& Yahr Stage I-III.\n* Aged between 40-80 years.\n* Literate and capable of performing basic mathematical calculations.\n* Montreal Cognitive Assessment≥21\n* Stable pharmacological treatment.\n* Physician's approval for exercise participation.\n\nExclusion Criteria:\n\n* Currently participating in another exercise or drug trial.\n* Presence of any additional neurological disorders.\n* Significant musculoskeletal disorders, arthritis, or cardiovascular disease.\n* Uncontrolled epilepsy or severe orthostatic hypotension.\n* Engaged in regular moderate-intensity exercise more than once a week in the last 6 months.",{"count":414,"type":24},34,[92],"This prospective, randomized, single-blind, controlled clinical trial aims to evaluate and compare the efficacy of cognitive-based balance rehabilitation delivered via immersive Virtual Reality (VR) versus traditional Dual-Task Training (DTT) on balance, gait, cognitive functions, and quality of life in patients with Parkinson's Disease (PD). Postural instability and cognitive decline are hallmark features of progressive PD that significantly elevate fall risks and compromise daily independence, yet conventional pharmacological therapies offer limited effectiveness in restoring complex postural control. Given that motor and cognitive processes are intrinsically linked, this study addresses a critical gap in neurorehabilitation by investigating two contemporary modalities designed to challenge these systems simultaneously. A total of 34 participants diagnosed with PD (aged 40-80 years, Hoehn and Yahr stages I-III) will be randomly allocated to either the Dual-Task Group (DTG), receiving structured therapeutic exercises integrated with sequential cognitive tasks, or the Virtual Reality Group (VRG), engaging in an immersive balance program utilizing the Oculus Quest 2® headset with the FIT-XR application. Both groups will undergo an identical intervention protocol consisting of 45-minute supervised sessions, conducted twice weekly for 8 consecutive weeks during their pharmacological \"on\" phase. Standardized assessments will be performed by a blinded clinician at baseline and post-intervention (Week 8). The primary outcome measures will be dynamic balance and gait assessed through the Mini-Balance Evaluations Systems Test (Mini-BESTest) alongside global cognitive performance measured via the Montreal Cognitive Assessment (MoCA). Secondary outcomes will encompass objective posturographic indices using the Biodex Balance System, motor severity via the Unified Parkinson's Disease Rating Scale (UPDRS-III), freezing of gait, health-related quality of life, global perceived improvement, and potential cyber-sickness symptoms monitored through the Virtual Reality Sickness Questionnaire (VRSQ) to comprehensively determine the safety and comparative therapeutic value of these interventions.",[29,28,418,419,420,421,422],"Parkinson s Disease","Postural Instability","Postural Instability Gait Disorders","Gait Disorders","Cognitive Dysfunction, Cognitive Disorder",[250,419,421,424,425,426],"Cognitive Dysfunction","Dual Task","Virtual Reality","2026-06-23",{"date":372,"type":42},{"date":430,"type":24},"2026-06-20",{"date":432,"type":24},"2027-12-30",{"name":434,"class":49},"Bezmialem Vakif University",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":18,"sex":19,"minAge":59,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":90,"phases":445,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":135},"100644240","phase-1-a-clinical-study-to-evaluate-the-safety-of-mf1-a-new-treatment-for-parkinsons-disease-related-disorders-mf1-study-100644240","NCT07666022","A Clinical Study to Evaluate the Safety of MF1, a New Treatment for Parkinson's Disease-related Disorders (MF1 Study)","A Phase I Investigator-initiated First-in-human Study to Evaluate the Safety and Pharmacokinetics of MF1 in Healthy Adults and Patients With Parkinson's Disease (MF1-FIH)","Inclusion Criteria:\n\n(Parts A and B)\n\n* 1)Healthy Japanese male adults aged \\>=18 and \\\u003C45 years at the time of informed consent.\n* 2\\) Subjects with a body mass index (BMI) of \\>=18.5 and \\\u003C25.0 kg\u002Fm2 at screening.\n* 3\\) Subjects who have received sufficient explanation regarding the study from the principal investigator or subinvestigator, have understood the objectives of the study, voluntarily agreed to participate, and have provided written informed consent of their own free will.\n\n(Part C)\n\n* 1\\) Patients diagnosed with idiopathic Parkinson's disease according to the International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic Criteria (2015).\n* 2\\) Patients with Parkinson's disease classified as Stage 3 or below according to the modified Hoehn and Yahr staging scale.\n* 3\\) Patients who are either untreated or have been receiving one of the following treatments at a stable dosage regimen for at least 8 weeks prior to screening, with no planned changes during the study period: selegiline up to 5 mg twice daily, rasagiline up to 1 mg once daily, or immediate-release carbidopa\u002Flevodopa up to 25\u002F100 mg three times daily.\n* 4\\) Patients with an average Bristol Stool Scale score of \\\u003C=3 from the date of informed consent to eligibility assessment, or patients with fewer than two bowel movements per week.\n\nIf the period between informed consent and eligibility assessment is less than one week, information prior to informed consent will also be collected to assess bowel conditions for at least one week in total.\n\n* 5\\) Male or female patients aged \\>=40 and \\\u003C85 years at the time of informed consent.\n* 6\\) Patients with a BMI of \\>=18.5 and \\\u003C32.0 kg\u002Fm2 at screening.\n* 7\\) Female patients who are postmenopausal for at least one year at the time of informed consent, including menopause resulting from hysterectomy or oophorectomy.\n* 8\\) Patients who have received sufficient explanation regarding the study from the principal investigator or subinvestigator, have understood the objectives of the study, voluntarily agreed to participate, and have provided written informed consent of their own free will.\n\nExclusion Criteria:\n\n(Parts A and B)\n\n* 1\\) Subjects with clinically significant cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunological, endocrine, or psychiatric disorders, or any other abnormalities that may affect safety, increase seizure risk, lower seizure threshold, or confound study results.\n* 2\\) Subjects with current or past diseases or surgical histories involving the gastrointestinal tract, liver, kidneys, or other organs that may affect drug absorption, metabolism, or excretion.\n* 3\\) Subjects who used any medication, including over-the-counter drugs, within 7 days prior to the day before the first administration of the investigational product.\n* 4\\) Subjects with seizure disorders such as epilepsy, or a history thereof.\n* 5\\) Subjects with allergies or a history of allergies to drugs or foods.\n* 6\\) Subjects with allergic predisposition who are considered unsuitable for participation by the principal investigator or subinvestigator.\n* 7\\) Subjects with current or past alcohol or drug dependence.\n* 8\\) Subjects who donated \\>=400 mL of whole blood within 12 weeks, \\>=200 mL of whole blood within 4 weeks, or blood components within 2 weeks prior to investigational product administration.\n* 9\\) Subjects who tested positive at screening for HBs antigen, HCV antibody, HIV antigen\u002Fantibody, or syphilis serology (TP antibody test or RPR test).\n* 10\\) Subjects unwilling to use appropriate contraception from the time of informed consent until the final study visit.\n* 11\\) Subjects who answered \"Yes\" to Question 4 or 5 regarding suicidal ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, or who had a history of suicidal behavior within 6 months prior to screening.\n* 12\\) Subjects who received investigational treatment in another clinical trial within 4 months prior to investigational product administration.\n* 13\\) Subjects judged unsuitable for study participation by the principal investigator or subinvestigator based on findings from screening or admission assessments, observations, or examinations.\n\n(Part C)\n\n* 1\\) Patients with drug-induced parkinsonism, metabolic neurogenetic disorders, encephalitis, Parkinson-plus syndromes, or other atypical parkinsonian syndromes.\n* 2\\) Patients with freezing of gait.\n* 3\\) Patients with a history of stereotactic brain surgery for Parkinson's disease (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplantation).\n* 4\\) Patients with clinically significant cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunological, endocrine, or psychiatric disorders other than Parkinson's disease, or any other abnormalities that may affect safety, increase seizure risk, lower seizure threshold, or confound study results.\n* 5\\) Patients with current or past diseases or surgical histories involving the gastrointestinal tract, liver, kidneys, or other organs that may affect drug absorption, metabolism, or excretion.\n* 6\\) Patients with seizure disorders such as epilepsy, or a history thereof.\n* 7\\) Patients currently receiving antiplatelet agents or anticoagulants.\n* 8\\) Patients with allergies or a history of allergies to drugs or foods.\n* 9\\) Patients with allergic predisposition who are considered unsuitable for participation by the principal investigator or subinvestigator.\n* 10\\) Patients with current or past alcohol or drug dependence.\n* 11\\) Patients who donated \\>=400 mL of whole blood within 16 weeks, \\>=200 mL of whole blood within 4 weeks, or blood components within 2 weeks prior to investigational product administration.\n* 12\\) Patients who tested positive at screening for HBs antigen, HCV antibody, HIV antigen\u002Fantibody, or syphilis serology (TP antibody test or RPR test).\n* 13\\) Patients unwilling to use appropriate contraception from the time of informed consent until the final study visit.\n* 14\\) Patients who answered \"Yes\" to Question 4 or 5 regarding suicidal ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, or who had a history of suicidal behavior within 6 months prior to screening.\n* 15\\) Patients who received investigational treatment in another clinical trial within 4 months prior to investigational product administration.\n* 16\\) Patients judged unsuitable for study participation by the principal investigator or subinvestigator based on findings from screening or admission assessments, observations, or examinations.","85 Years",{"count":444,"type":24},58,[446],"PHASE1","This is a Phase I, investigator-initiated, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of MF1, a novel agent that is expected to inhibit α-synuclein related pathogenesis in α-synucleinopathies, primarily Parkinson's disease (PD). MF1 aims to address the unmet medical need in PD, which affects about 1% of individuals aged 60 years and older in Japan and is projected to reach 43 million patients worldwide by 2050.\n\nThe trial consists of three parts: Part A (single ascending dose) and Part B (multiple ascending dose) in healthy Japanese male adults, and Part C (multiple dose) in patients with idiopathic PD. Part A is a randomized, double-blind, placebo-controlled, single-center study assessing single oral doses , including a food-effect evaluation. Part B is a randomized, double-blind, placebo-controlled, single-center study with once-daily dosing for 7 days. Part C is an open-label, multicenter study in 4-8 PD patients (MDS 2015 criteria, Hoehn \\& Yahr stage ≤3) receiving once daily for 14 days, with or without stable background antiparkinsonian therapy.\n\nThe primary objective is to assess safety and tolerability; secondary objectives include characterization of plasma, urine, and cerebrospinal fluid pharmacokinetics and assessment of food effect. Exploratory pharmacodynamic endpoints include biomarkers such as α-synuclein, neurofilament light chain, UCHL-1, FABP3, GFAP, and other neurodegeneration markers.\n\nKey exclusion criteria include clinically significant systemic diseases, seizure history, serious infections (HBV, HCV, HIV, syphilis), recent suicidal ideation or attempts, and recent use of other investigational products.",[449,29],"Healthy Adult Male",[451],"FIH","2026-06-18",{"date":398,"type":42},{"date":455,"type":42},"2026-06-01",{"date":457,"type":24},"2028-10-31",{"name":459,"class":49},"University of Shizuoka",{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":19,"minAge":243,"maxAge":193,"enrollmentInfo":467,"targetDuration":4,"studyType":90,"phases":469,"briefSummary":470,"conditions":471,"keywords":472,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":79},"100644434","effects-of-tai-chi-therapy-versus-qi-gong-in-stage-i-parkinsons-patients-100644434","NCT07662837","Effects of Tai Chi Therapy Versus Qi-Gong in Stage-I Parkinson's Patients.","Effects of Tai Chi Therapy Versus Qi-Gong on Postural Control, Functional Balance , and Motor Function in Stage-I Parkinson's Patients.","Inclusion Criteria:\n\nDiagnosis of PD based on the Hoehn \\& Yahr staging system (Stages I). Male or female patients aged between 50-65 years. Currently receiving stable anti-Parkinsonian medication, with no changes in the treatment regimen for at least 3 months. Basic self-care ability with no severe cognitive impairment (Mini-Mental State Examination \\[MMSE\\] score ≥24).\n\nExclusion Criteria:\n\nDepression, as assessed based on a score of \\>16 for the Beck Depression Inventory-II (BDI-II). Recent deep brain stimulation (DBS) treatment. Use of medication that interferes with cognition, alertness, or attention. Current participation in an exercise training program.",{"count":468,"type":24},50,[92],"This study has important clinical, academic, and practical relevance in neuromuscular rehabilitation. Clinically, it aims to identify effective and tolerable rehabilitation strategies for individuals with Parkinson's disease by comparing Tai Chi Therapy with Qi-Gong there by supporting evidence-based physiotherapy practice and improving patient adherence. Academically, it contributes to the limited literature on comparative effectiveness of these interventions and incorporates patient-centered outcomes such as exercise perception, which are often underreported. From a practical and societal perspective, identifying a more acceptable and effective approach may enhance long-term participation in rehabilitation, potentially slow disease progression, and reduce the overall healthcare burden associated with Parkinson's disease.",[29],[473,474],"Tai Chi","Qi-Gong","2026-06-17",{"date":427,"type":42},{"date":478,"type":42},"2026-05-30",{"date":480,"type":24},"2026-10-10",{"name":482,"class":49},"Lahore University of Biological and Applied Sciences",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":21,"enrollmentInfo":489,"targetDuration":4,"studyType":90,"phases":491,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":135},"100635824","phase-1-using-tavns-to-modulate-cardiovascular-function-in-individuals-with-neurologic-disease-100635824","NCT07557706","Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease","Inclusion Criteria:\n\n* Diagnosis of idiopathic PD\n* Stable medication for at least 4 weeks prior to the study\n\nExclusion Criteria:\n\n* Use of beta blockers\n* Sustained severe hypertension (\\>\u002F= 180\u002F110 mmHg while seated)\n* Significant uncontrolled cardiac arrhythmia\n* Unstable angina\n* Congestive heart failure\n* History of myocardial infarction\n* History of seizures\n* Severe cognitive impairment\n* Pregnant women or women who are planning to become pregnant",{"count":490,"type":24},24,[446],"The purpose of this study is to find out whether a type of gentle nerve stimulation, called transcutaneous auricular Vagus Nerve Stimulation (taVNS), can help improve how the body regulates heart rate and blood pressure in people with Parkinson's Disease (PD). Problems with heart rate and blood pressure control are common and can make it harder for people to exercise or do daily activities. By using this non-invasive form of nerve stimulation and testing how it affects the body's natural responses, this study hopes to learn if taVNS could be a helpful tool to support physical therapy and improve overall function.",[29],[495,496,497],"vagus nerve stimulation","neuromodulation","parkinson's disease","2026-06-16",{"date":452,"type":42},{"date":501,"type":42},"2025-09-15",{"date":503,"type":24},"2026-12-31",{"name":234,"class":49},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":19,"minAge":243,"maxAge":144,"enrollmentInfo":512,"targetDuration":4,"studyType":90,"phases":514,"briefSummary":515,"conditions":516,"keywords":517,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":526,"locationsCount":135},"100635603","effects-of-accelerated-rtms-on-motor-and-cognitive-function-in-parkinsons-disease-100635603","NCT07554833","Effects of Accelerated rTMS On Motor and Cognitive Function in Parkinson's Disease","Clinical Effects of Accelerated rTMS Targeting Motor Cortex on Motor and Cognitive Function in Parkinson's Disease: A Prospective Pilot Study","Inclusion Criteria:\n\n* Subject must be 50 to 90 years of age, inclusive, on the day of signing informed consent.\n* Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria or UK Parkinson's Disease Society Brain Bank criteria.\n* Hoehn and Yahr stage 1-3 (mild to moderate disease severity).\n* MDS-UPDRS-III (Motor Examination) score ≥10 at screening.\n* Stable doses of anti-parkinsonian medications (including levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine) for at least 4 weeks prior to screening, with no anticipated changes during the study period.\n* Ability to provide written informed consent.\n* Subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n* Sufficient visual and auditory acuity to complete motor and cognitive assessments.\n* Availability and willingness to complete all scheduled study visits.\n* Presence of a reliable study partner or caregiver who can provide information about the participant's motor, cognitive, and functional status.\n* Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the contralateral hand muscles.\n* Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement in motor or cognitive function, including non-invasive brain stimulation treatments other than the study procedure during study participation.\n* Subjects willing and able to maintain their regular (pre-procedure) medication regimen, diet, and exercise routine without affecting significant change in either direction during study participation.\n* Willingness to comply with study instructions and to return to the clinic for the required visits.\n* Women of child-bearing potential are required to use birth control measures during the whole duration of the study.\n\nExclusion Criteria:\n\n* Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.\n* Metallic, ferromagnetic, or other magnetic-sensitive implants\u002Fobjects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic, or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 inches (30 cm) of the therapy coil. Examples include implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes, and tattoos with metallic ink.\n* Drug pumps within 12 inches (30 cm) of the therapy coil.\n* Inability to determine the motor threshold of the participant (i.e., the minimum stimulus required to induce contraction of the contralateral hand muscles cannot be established).\n* History of seizure disorder or epilepsy, except for a single remote seizure more than 5 years ago, which may be permitted at investigator discretion.\n* Elevated risk of seizure due to traumatic brain injury with loss of consciousness \\>30 minutes within the past 12 months.\n* Current use of medications known to significantly lower seizure threshold (e.g., clozapine, bupropion at doses \\>450 mg\u002Fday, theophylline, high-dose tricyclic antidepressants) or recent dose reduction of anticonvulsant medications or benzodiazepines within 4 weeks of screening.\n* Atypical parkinsonism or Parkinson-plus syndromes (e.g., progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration).\n* Hoehn and Yahr stage 4 or 5 (severe disease with significant disability).\n* Severe dementia, defined as MoCA score below 10, or inability to follow simple verbal commands or complete basic motor and cognitive assessments.\n* Rapidly progressive cognitive decline or suspected prion disease, autoimmune encephalitis.\n* Brain tumor, intracranial hemorrhage within the past 12 months, arteriovenous malformation, or increased intracranial pressure.\n* Acute stroke within the past 3 months.\n* Prior deep brain stimulation (DBS) surgery or other neurosurgical procedures for Parkinson's disease.\n* Has a current diagnosis of psychotic disorder, bipolar disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the subject's ability to participate in the trial.\n* Has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening.\n* History of substance or alcohol use disorder of moderate to severe severity according to DSM-5 criteria within 6 months before screening, or positive test result(s) for drugs of abuse (including opiates, cocaine, cannabinoids, methamphetamines, amphetamines) at screening.\n* Has history of or current clinically significant and\u002For unstable medical condition that could interfere with study participation or pose safety concerns, including but not limited to: Moderate or severe hepatic impairment (Child-Pugh Score ≥7); Severe renal impairment (estimated creatinine clearance below 30 mL\u002Fmin or serum creatinine \\>2 mg\u002FdL); Unstable cardiac, vascular, or pulmonary disease Note: Subjects with chronic but stable, well-controlled conditions may be allowed in the study upon agreement with the investigator.\n* Has uncontrolled hypertension (systolic blood pressure \\>160 mm Hg or diastolic blood pressure \\>100 mm Hg, despite diet, exercise, or a stable dose of antihypertensive therapy) at screening.\n* Has clinically significant ECG abnormalities at screening, defined as: QTc interval (Fridericia's formula): ≥450 msec (males); ≥470 msec (females); Evidence of 2nd or 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval \\>210 msec; Left bundle branch block; Features of new ischemia; Other clinically important arrhythmia\n* Has a known malignancy or history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that, in the opinion of the investigator, is considered cured with minimal risk of recurrence).\n* Had clinically significant acute illness within 7 days prior to study rTMS treatment.\n* Had major surgery (e.g., requiring general anesthesia) within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Note: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.\n* Is pregnant or breastfeeding while enrolled in this study or within 1 month after the last session of study rTMS treatment.\n* Has received an investigational drug or used an invasive investigational medical device within 3 months before screening, or is currently enrolled in an investigational study.\n* Prior treatment with rTMS within 6 months of screening.\n* Subjects willing to partake in any treatments other than the study procedure for the improvement in cognitive function, including non-invasive brain stimulation treatments other than the study procedure, during study participation.\n* Has psychological and\u002For emotional problems which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements.\n* Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n* Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.",{"count":513,"type":24},40,[92],"Parkinson's disease (PD) is a brain disorder that causes progressive problems with movement, such as slowness, stiffness, tremor, and difficulty walking. Many people with PD also develop problems with thinking and memory. Current medications can help control movement symptoms but often become less effective over time and may cause side effects. There is a need for additional treatment options that can address both movement and thinking difficulties in PD.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses delivered to the scalp to stimulate specific areas of the brain. Previous research has shown that rTMS targeting the motor cortex (the part of the brain that controls movement) can improve motor symptoms in people with PD.\n\nThe purpose of this pilot study is to evaluate whether an accelerated course of rTMS targeting the motor cortex can improve movement and thinking abilities in people with mild to moderate Parkinson's disease. The study will enroll 40 participants aged 50 to 90 years at the San Francisco Neurology and Sleep Center.\n\nParticipants will receive 6 sessions of rTMS using the EXOMIND™ device, administered twice per week over approximately 3 weeks. Each session delivers high-frequency magnetic stimulation to the motor cortex on both sides of the brain. Participants will be assessed before treatment, at the last treatment session, and at 1-month and 3-month follow-up visits.\n\nThe primary outcome measure is the change in motor symptoms as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) at 1 month after treatment. Secondary outcomes include additional measures of walking and gait, domain-specific cognitive testing using the Creyos cognitive battery (assessing memory, attention, reasoning, and other thinking skills), the Montreal Cognitive Assessment (MoCA), depression symptoms (PHQ-9), and quality of life (PDQ-39).\n\nThis is a single-center, open-label study with no placebo or control group. Total participation duration is up to 139 days, including screening, treatment, and follow-up visits.",[29,418],[518,519,202,173,520],"rTMS","ExoMind","Cognitive Function","2026-06-12",{"date":498,"type":42},{"date":524,"type":24},"2026-06-03",{"date":378,"type":24},{"name":527,"class":49},"San Francisco Neurology and Sleep Center",{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":90,"phases":536,"briefSummary":537,"conditions":538,"keywords":540,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":552,"leadSponsor":554,"locationsCount":4},"100643119","telerehabilitation-versus-face-to-face-lsvt-big-in-individuals-with-parkinson-disease-100643119","NCT07630792","Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease","The Effects of Telerehabilitation and Face-to-Face LSVT BIG Method on Motor and Non-Motor Symptoms in Individuals With Parkinson Disease","Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease\n* Hoehn and Yahr stage 1-3\n* Montreal Cognitive Assessment (MoCA) score ≥ 21\n* Ability to use a smartphone, tablet, or computer\n* Access to internet connection and basic digital literacy\n* Participation in activities outside the home at least 3 days per week\n\nExclusion Criteria:\n\n* Diagnosis of a neurological condition other than idiopathic Parkinson's disease\n* Change in antiparkinsonian medication regimen during the study period\n* History of deep brain stimulation\n* Visual or hearing impairment that would prevent participation in treatment or assessments\n* Severe cardiovascular, orthopedic, pulmonary, or systemic comorbidity contraindicating exercise\n* Diagnosis of severe depression, psychotic disorder, or uncontrolled psychiatric illness\n* Participation in another structured physiotherapy or rehabilitation program for\n* Parkinson's disease within the last three months",{"count":513,"type":24},[92],"This prospective, randomized controlled trial will enroll 40 individuals with idiopathic PD (Hoehn \\& Yahr stages 1-3, MoCA ≥21). Participants will be randomly assigned in a 1:1 ratio to either a telerehabilitation LSVT BIG group or a face-to-face LSVT BIG group, with randomization stratified by Hoehn \\& Yahr stage using a computer-based block randomization system. Both groups will receive the standard LSVT BIG® protocol consisting of 16 sessions over four weeks (4 days\u002Fweek, 1 hour\u002Fsession). Treatment content will include maximal daily exercises, functional component tasks, \"big\" gait training, and individually tailored hierarchy tasks. The telerehabilitation group will receive all sessions via synchronous video conferencing under physiotherapist supervision, while the face-to-face group will receive sessions in a clinical setting. Both groups will be assigned home exercise programs in accordance with the LSVT BIG® protocol, and treatment adherence will be monitored throughout the study.\n\nOutcomes will be assessed at baseline, after 4 weeks of treatment, and at 6-month follow-up. Primary outcomes include postural stability and fall risk assessed with the Biodex Balance System (anterior-posterior stability index, mediolateral stability index, general stability index, fall risk index, limits of stability) and motor and non-motor symptom severity assessed with the MDS-UPDRS (Parts I, II, and III). Secondary outcomes include dynamic balance (Mini-BESTest), functional mobility (Timed Up and Go Test, 10-Meter Walk Test), quality of life (PDQ-39), depression (Beck Depression Inventory), sleep quality (Parkinson's Disease Sleep Scale), fatigue (Parkinson Fatigue Scale), cognitive function (MoCA), and treatment satisfaction (Global Rating of Change Scale).",[29,539,250],"Parkinson Disease (PD), Postural Balance",[250,541,542,95,543,544,545,546,547],"LSVT BIG","Telerehabilitation","Non-Motor Symptoms","Balance","Neuroplasticity","Randomized Controlled Trial","Physical Therapy","2026-06-09",{"date":550,"type":42},"2026-06-11",{"date":430,"type":24},{"date":553,"type":24},"2028-06-30",{"name":434,"class":49},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":21,"enrollmentInfo":563,"targetDuration":4,"studyType":90,"phases":564,"briefSummary":565,"conditions":566,"keywords":570,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":4},"100643698","auto-calibrating-system-for-upper-limb-disability-assessment-neurological-and-occupational-rehabilitation-100643698","NCT07636538","Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation","Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation (AS-ULDAR)","ASULDAR","Inclusion Criteria:\n\n* Adult patients aged between 18 and 80 years.\n* Confirmed diagnosis of one of the following neurological conditions: stroke, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), or Mild Cognitive Impairment (MCI).\n* Presence of upper limb motor impairment defined by QuickDASH scores ranging from 20 to 90.\n* Ability to understand and follow the study protocol instructions.\n\nExclusion Criteria:\n\n* Patients with severe psychiatric disorders or cognitive impairments that interfere with the ability to complete cognitive tests and self-assessment scales.\n* Individuals unable to provide informed consent.\n* Subjects with moderate to severe cognitive impairment, defined by an ECAS score lower than 81.92 (ALS patients) or a MoCA score between 18 and 25.\n* Physical conditions significantly limiting upper limb use (e.g., severe concomitant orthopedic disorders affecting shoulder movement).\n* Current or recent participation (within the previous three months) in other rehabilitation programs or interventions that could influence study outcomes.\n* Unstable health conditions that could make device use unsafe or inappropriate, including unstable medical conditions or severe visual impairments.",{"count":146,"type":24},[92],"This interventional, multicenter, low-intervention clinical trial aims to evaluate the usability, feasibility, safety, and preliminary clinical impact of a robotic rehabilitation system designed for upper limb rehabilitation in adults with neurological disorders, including Parkinson's disease (PD), Amyotrophic Lateral Sclerosis (ALS), post-stroke sequelae, and Mild Cognitive Impairment (MCI).\n\nThe system under study combines a collaborative robot (cobot), inertial sensors, and a graphical user interface capable of supporting reaching exercises, trajectory tracking activities, and cognitive exergames, while also enabling automatic acquisition and visualization of patient performance data.\n\nThe main questions the study aims to answer are:\n\nIs the investigational robotic rehabilitation system usable and feasible in neurological patients undergoing upper limb rehabilitation? Is the use of the device safe for both patients and healthcare operators? Does the addition of robotic-assisted rehabilitation to conventional therapy improve upper limb motor performance, cognitive function, and quality of life compared with conventional rehabilitation alone? Do movement measurements collected by the system correlate with standard clinical assessment scales?\n\nResearchers will compare conventional rehabilitation therapy plus robotic-assisted rehabilitation with conventional rehabilitation therapy alone to evaluate the impact of the device on motor, cognitive, and psychosocial outcomes.\n\nThirty participants will be randomized into two parallel treatment groups. Both groups will receive 12 sessions of conventional rehabilitation therapy lasting 60 minutes each, three times per week. Participants assigned to the experimental group will additionally receive robotic-assisted rehabilitation sessions of up to 30 minutes supervised by rehabilitation staff.\n\nParticipants will undergo:\n\nBaseline collection of demographic and clinical information; Motor, cognitive, and activities of daily living assessments using standardized clinical scales; Conventional rehabilitation therapy sessions; Robotic-assisted upper limb rehabilitation exercises, including task-oriented and trajectory-tracking activities (experimental group only); Monitoring of vital parameters and adverse events during device use; Final evaluation of usability, psychosocial impact, patient satisfaction, motor and cognitive outcomes, and safety.",[567,568,29,569],"Stroke","Amyotrophic Lateral Sclerosis","Mild Cognitive Impairment (MCI)",[571,572,573,574],"Collaborative Robot","Robotic rehabilitation","Neurological disorders","Graphical User Interface",{"date":548,"type":42},{"date":577,"type":24},"2026-06",{"date":579,"type":24},"2026-10",{"name":581,"class":49},"University of Pavia",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":21,"enrollmentInfo":589,"targetDuration":4,"studyType":90,"phases":590,"briefSummary":591,"conditions":592,"keywords":594,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":604},"100625441","phase-1-sad-study-in-patients-with-parkinsons-disease-and-motor-fluctuations-100625441","NCT07422675","SAD Study in Patients With Parkinson's Disease and Motor Fluctuations","A Randomized, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety, Tolerability, and Pharmacokinetics of SER-252 in Patients With Parkinson's Disease and Motor Fluctuations","Inclusion criteria\n\n1. Female or male participants 40-80 years of age, inclusive, at the time of screening\n2. Diagnosis of idiopathic Parkinson's disease consistent with UK Brain Bank and MDS Research Criteria; must include bradykinesia with sequence effect, motor asymmetry if no rest tremor, and a reliable, visible response to levodopa\n3. On a stable regimen of anti-Parkinsonian medication for at least 4 weeks prior to Screening; MAOBIs must be stable for at least 12 weeks prior to Screening\n4. Routine early-morning OFF, corroborated by investigator interview at Screening\n5. Presence of a total daily OFF time duration of ≥2 hours during the waking day based on participant self-assessment and Investigator's judgment\n6. \\*Hoehn and Yahr scale ≤ 3 in the ON state during screening (\\*part of the MDS- UPDRS Part III assessment)\n7. Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary or Crexont)\n8. Ability to return to the clinic for blood sampling, clinical and laboratory assessment on scheduled days, based upon cohort\n9. Montreal Cognitive Assessment ≥ 24\n10. Women of child-bearing potential (WOCBP) who are sexually active with a male partner must use a reliable method of contraception from the time of consent through at least 3 months after the last dose of study medication. Reliable methods of contraception include oral contraceptive or long-term injectable or implantable hormonal contraceptive, or intra-uterine devices when used in combination with male condoms, and must have a negative serum pregnancy test at Screening and negative urine pregnancy test at baseline. Males who are sexually active and whose partners are females of childbearing potential must agree to use male condoms from the time of consent through 3 months after administration of the last dose of study drug, and their partners must be willing to use a highly effective method of contraception from screening through 3 months after administration of the last dose of study drug.\n11. Willing and able to comply with all study activities and requirements, including safety follow-up\n12. Provide written informed consent\n13. Approved by a central Enrollment Authorization Committee (EAC)\n\nExclusion criteria\n\n1. Diagnosis of secondary or atypical parkinsonism\n2. Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e., Duopa, apomorphine), surgery for PD (i.e., DBS), or anticipation of these during the study\n3. History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia\n4. Clinically debilitating motor complications as determined by the principal investigator or delegate (severe, disabling dyskinesias or severe OFF)\n5. Participant inability to differentiate motor states (OFF\u002FON\u002FON with mild\u002Fmoderate\u002Fsevere dyskinesias) after training\n6. Clinically significant orthostatic hypotension (consistently symptomatic or requires medication)\n7. Clinically significant hallucinations requiring antipsychotic use\n8. Clinically significant medical, surgical, psychiatric, or laboratory abnormalities that in the judgment of the principal investigator or delegate would preclude adequate participation or completion of the study\n9. Clinically significant ECG abnormalities at Screening\n10. Prolonged Fridericia-corrected QT (QTcF) interval on ECG at Screening (defined as a QTcF interval of \\>450 msec for males and 470 for females)\n11. Clinically significant heart disease within 2 years of Screening, defined as follows:\n\n    A. Significant cardiac event within 12 weeks prior to Screening (e.g., admission for myocardial infarction, unstable angina, or decompensated heart failure), angina pectoris or episode of congestive heart failure with symptoms \\> grade 2 New York Heart Association classification, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia B. History of complex arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment (Common Terminology Criteria for Adverse Events grade 3) C. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia D. Symptomatic bradycardia, sick sinus syndrome or atrioventricular block greater than first degree in the absence of a pacemaker E. Unexplained syncope F. Brugada syndrome G. Hypertrophic cardiomyopathy\n12. Active major depressive disorder or history of clinically significant impulse control disorder, in the opinion of the Principal Investigator or delegate, or EAC.\n\n    Note: Participants receiving treatment for depression with antidepressants may be enrolled if they have been on a stable daily dose of the antidepressant for at least 8 weeks prior to Screening.\n13. Has active suicidal ideation within one year prior to Screening as determined by the C-SSRS (answer of \"yes\" on questions 4 or 5) or attempted suicide within the last 5 years\n14. Has been diagnosed with or history of a substance-related disorder (excluding nicotine and caffeine), including alcohol-related disorder by DSM-V criteria, during the 12 months prior to Screening\n15. Tests positive at Screening for drugs of abuse (amphetamines (AMP), barbiturates (BAR), benzodiazepines (BZO), cocaine (COC), opiates (OPI), methamphetamines (MET), methadone (MTD), Phencyclidine (PCP), tetrahydrocannabinol (THC), tricyclic antidepressants (TCA)) Note: does not exclude patients on physician-prescribed medications.\n16. Has ALT or AST levels greater than 2.5 times the ULN or bilirubin \\> 2.0 mg\u002FdL, or \\> 34.2 µmol\u002FL\n17. Significant renal impairment as determined by eGFR, using Cockcroft-Gault method, less than or equal to 55 ml\u002Fmin or serum creatinine \\>2.0 mg\u002FdL or \\>177 µmol\u002FL\n18. Has a positive test result for HBsAg, HCV antibody, or HIV infection at Screening\n19. Currently lactating or pregnant or planning to become pregnant during the study.\n20. Previous intolerance of apomorphine\n21. Currently participating in or has participated in another investigational study within the last 30 days or 5 half-lives, or 90 days for biologics",{"count":513,"type":24},[446],"This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.",[29,593],"Advanced Parkinson's Disease",[595],"advanced Parkinson's Disease",{"date":597,"type":42},"2026-06-05",{"date":599,"type":42},"2026-02-01",{"date":601,"type":24},"2027-01-31",{"name":603,"class":184},"Serina Therapeutics",6,{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":165,"enrollmentInfo":613,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":614,"conditions":615,"keywords":4,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":620,"leadSponsor":622,"locationsCount":79},"100643586","local-field-potential-correlates-of-neuropsychiatric-symptoms-in-parkinsons-disease-100643586","NCT07633379","Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease","Intracranial Local Field Potential (LFP) Correlates of Neuropsychiatric Symptoms in Parkinson's Disease","LFP-in-PD","Inclusion Criteria:\n\n* Age ≥ 18 years\n* A diagnosis of Parkinson's Disease\n* A diagnosis of hallucinations, impulse control disorder, or panic disorder (episodic anxiety)\n* Previous bilateral DBS implantation with a Medtronic Percept device as part of clinical care\n\nExclusion Criteria:\n\n* Non-English speakers\n* \\\u003C18 years old or \\>75 years old\n* A history of concurrent conditions that could significantly confound the study results, such as other significant neurological condition (e.g., brain injury\u002Finfection, substance abuse) or concurrent severe psychiatric condition (e.g., schizophrenia)\n* Moderate\u002Fsevere Intellectual Disability or inability to understand study procedures\n* Lack of capacity to consent to the study\n* Currently involvement in other studies",{"count":221,"type":24},"This prospective observational cohort study aims to investigate whether intracranial Local Field Potentials (LFPs) recorded from implanted Deep Brain Stimulation (DBS) devices are associated with neuropsychiatric symptoms in people with Parkinson's disease (PD). The study will focus on paroxysmal anxiety, impulse control disorders, and hallucinations.\n\nTwenty participants with Parkinson's disease and an implanted Medtronic Percept DBS device will be recruited. Participants will complete behavioural and clinical assessments and will use the event-marking functionality of the DBS device to record symptom episodes over a monitoring period of approximately 120 days. Brain activity will be passively recorded during this period.\n\nThe study will evaluate relationships between LFP signals, symptom occurrence, behavioural task performance, and clinical symptom severity measures. Machine learning approaches will be used to identify electrophysiological patterns associated with neuropsychiatric symptom states at an individual level.\n\nThe findings may improve understanding of the neural mechanisms underlying neuropsychiatric symptoms in Parkinson's disease and support the future development of personalised adaptive neuromodulation approaches.",[29],"2026-06-02",{"date":618,"type":42},"2026-06-08",{"date":455,"type":24},{"date":621,"type":24},"2028-02-01",{"name":623,"class":49},"King's College London",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":90,"phases":633,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":135},"100638187","feasibility-of-a-community-based-multimodal-exercise-programme-in-parkinsons-disease-100638187","NCT07618728","Feasibility of a Community-Based Multimodal Exercise Programme in Parkinson's Disease","Feasibility and Preliminary Effectiveness of an Individualised Multimodal Group-Based Exercise Programme for People With Parkinson's Disease: A Non-Randomized Feasibility Study","Eligibility Criteria The eligibility criteria will be identical for both the experimental and control groups. However, this study will employ a sequential recruitment design. Participants for the control group will be recruited following the experimental group and will be matched (1:1 ratio) based on sex, age (± 5 years), and disease severity according to the Hoehn \\& Yahr (H\\&Y) scale.\n\nInclusion Criteria:\n\n* Subjects diagnosed with Idiopathic Parkinson's Disease according to the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria.\n* Subjects staged between 1 and 3 on the Hoehn \\& Yahr Scale. For matching purposes, stage 1 includes stage 1.5, and stage 2 includes stage 2.5.\n\nExclusion Criteria:\n\n* Subjects diagnosed with a neurological disease other than PD.\n* Those diagnosed with a cardiovascular, respiratory, or metabolic disease or other conditions that represent a contraindication to physical exercise.\n* Those who have suffered an exacerbation or hospitalization in the last three months prior to starting the assessment protocol or during the therapeutic intervention process.\n* Those who have received a course of steroids, intravenously or orally, six months prior to the start of the study or during the therapeutic intervention process.\n* Those with cognitive impairment (defined as a score \\\u003C 21 on the Montreal Cognitive Assessment, MoCA) or language impairments that prevent adequate communication, comprehension, or following of exercise instructions.\n* Participation in a structured, individualized strength and\u002For aerobic exercise program within the three months prior to enrollment.",{"count":632,"type":24},64,[92],"This study aims to evaluate the feasibility and preliminary effectiveness of a multimodal, group-based but individualised therapeutic exercise programme for people with Parkinson's disease delivered within a real-world community-based patient association setting.\n\nThe primary objective is to assess the feasibility of implementing the programme, including recruitment, consent, adherence, intervention completion, acceptability, perceived exertion and safety. Secondary objectives are to obtain preliminary comparative information regarding the effects of the intervention on motor and non-motor symptoms, physical fitness, pain-related outcomes and exercise-induced hypoalgesia.\n\nThis is a non-randomized sequential feasibility study including an intervention group participating in a 12-week multimodal exercise programme and a matched non-exercise control group maintaining usual activities. Outcomes will be assessed at baseline, post-intervention and 6-month follow-up.",[29],[202,637,638,639,640,641,642],"Exercise programme","Feasibility","Multimodal","Individualised","Motor symptoms","Non-motor symptoms",{"date":524,"type":42},{"date":645,"type":42},"2025-09-08",{"date":647,"type":24},"2027-09",{"name":649,"class":49},"Universidad Rey Juan Carlos"]