[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"parkinson-disease-pd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:parkinson-disease-pd":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,53,0,25,[9,51,81,109,134,153,185,211,240,271,291,316,339,364,384,415,442,468,495,524,552,576,602,630,648],{"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":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100652481","exploring-the-efficacy-of-the-effortful-swallow-maneuver-for-improving-swallowing-in-people-with-pd-100652481","NCT07773025","Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With PD","EFFORT-PD: Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease","EFFORT-PD","Inclusion Criteria:\n\n* Age 18 years or older\n* Neurologist-confirmed diagnosis of Parkinson disease\n* Self-report of one or more swallowing symptoms, such as difficulty managing secretions, coughing during meals, choking on food, or respiratory infection other than COVID-19 in the past 6 months\n* Baseline videofluoroscopic swallowing assessment showing prolonged time to laryngeal vestibule closure and\u002For poor pharyngeal area at maximum constriction on regular-effort swallows with thin or mildly thick liquid stimuli, relative to healthy reference values\n\nExclusion Criteria:\n\n* History of head and neck cancer\n* History of radical neck dissection, anterior cervical spine surgery, or neck\u002Foropharyngeal surgery, except tonsillectomy or adenoidectomy\n* History of any neurological disease other than Parkinson disease\n* Cognitive or receptive communication difficulties that preclude the ability to follow English-language study instructions\n* History of brain surgery, including deep brain stimulation","18 Years",{"count":61,"type":24},74,"INTERVENTIONAL",[64],"NA","The goal of this clinical trial is to learn whether a 4-week effortful swallow exercise program helps adults with Parkinson disease who have swallowing problems. The effortful swallow is a swallowing exercise where a person swallows with extra effort.\n\nResearchers will compare adults who start the exercise program right away with adults who start the program after a 4-week waiting period. All participants who remain eligible will have the opportunity to receive the exercise program.\n\nParticipants will have swallowing assessments, including video X-ray swallowing tests called videofluoroscopy. They will also complete questionnaires and take part in a remotely supervised swallowing exercise program with a speech-language pathologist. Participants who remain eligible and take part in the exercise program will use a tongue pressure device during practice. The main study period lasts about 10 weeks. Participants will also complete brief follow-up questionnaires at 6 months and 12 months.",[67,28],"Dysphagia",[67,69,70],"Parkinson disease","effortful swallow","NOT_YET_RECRUITING","2026-08-14",{"date":74,"type":42},"2026-08-19",{"date":76,"type":24},"2027-01-01",{"date":78,"type":24},"2030-08-31",{"name":80,"class":49},"University of Alberta",{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":19,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":62,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100601827","daily-amino-acid-supplementation-for-people-with-parkinsons-disease-100601827","NCT07115563","Daily Amino Acid Supplementation for People With Parkinson's Disease","Effects of Targeted Amino Acid Supplementation for People With Parkinson's Disease on Amino Acid Profiles and Health Related Markers","Inclusionary Criteria:\n\n* Male and Females.\n* 50-80 Years.\n* Previous diagnosis of idiopathic Parkinson's Disease by patient report.\n* Use of dopamine replacement medication (e.g. levodopa) for at least 2 years.\n* On a stable dose of dopamine replacement medication for at least 3 months with no plans for change in the next two months.\n\nExclusionary criteria\n\n* Apparent cognitive impairment as determined by phone screening (Telephone Interview for Cognitive Status \\\u003C29).\n* Diagnosis of Parkinsonism or atypical Parkinson's Disease.\n* Prescription of Dopamine antagonist.\n* Any unstable medical condition.\n* Use of Deep Brain Stimulation.\n* Gastric or Bowel resection surgery.\n* Contraindications to blood draw.","50 Years","90 Years",{"count":91,"type":24},30,[64],"The goal of this clinical trial is to learn if a tailored amino acid supplement works to help adults living with Parkinson's disease to improve nutrition, metabolic function, body composition, and physical and mental function. The main questions it aims to answer are:\n\nDoes the tailored amino acid supplement increase essential amino acids (nutritional status)?\n\nDoes the tailored amino acid supplement increase an antioxidant (complex amino acid) and decrease an amino acid associated with oxidative stress?\n\nDoes the tailored amino acid supplement improve physical and mental health compared to a placebo supplement?\n\nResearchers will compare the tailored amino acid supplement to a placebo (a look-alike substance that contains no active ingredients) to see if the tailored amino acid supplements work to support health for people with Parkinson's disease.\n\nParticipants will:\n\nTake the tailored amino acid supplement or a placebo every day for 6 months, visit the lab at baseline, after 3 months, and after 6 months for fasting blood draws, body composition assessment, and physical and mental health testing and keep a diary of their food intake and supplement intake.",[28],[96,97,98],"Nutrition","Parkinson's disease","Amino acid supplements","2026-08-11",{"date":101,"type":42},"2026-08-13",{"date":103,"type":42},"2025-10-31",{"date":105,"type":24},"2027-11",{"name":107,"class":49},"Cristina Colon-Semenza",2,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":62,"phases":119,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"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":118,"type":24},60,[120],"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.",[29,123,124,28],"Pain","Pain Management","2026-08-07",{"date":101,"type":42},{"date":128,"type":42},"2026-04-28",{"date":130,"type":24},"2027-12",{"name":132,"class":49},"Universita di Verona",1,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":62,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":133},"100648510","different-frequency-temporal-interference-stimulation-on-bilateral-subthalamic-nucleus-for-parkinsons-disease-100648510","NCT07721688","Different Frequency Temporal Interference Stimulation on Bilateral Subthalamic Nucleus for Parkinson's Disease","A Single-Center, Double-Blind Randomized Controlled Trial of Different Frequency Temporal Interference Stimulation Applied to Bilateral Subthalamic Nucleus for Improving Motor and Vocal Functions in Patients With Parkinson's Disease.","Inclusion Criteria:\n\n1. Idiopathic Parkinson's disease diagnosed by neurologists according to the Movement Disorder Society Clinical Diagnostic Criteria;\n2. Hoehn and Yahr stage 1.5-3.0;\n3. Stable levodopa-based antiparkinsonian medication for at least 4 weeks before enrolment, with no planned medication change during the trial period;\n4. Ability to walk independently;\n5. Ability to understand and follow study instructions and complete the required assessments, with no severe cognitive impairment as screened by the Montreal Cognitive Assessment and\u002For Mini-Mental State Examination according to prespecified thresholds;\n6. Willingness to participate and provide written informed consent.\n\nExclusion Criteria:\n\n1. Any contraindication to MRI or tTIS, including claustrophobia or ferromagnetic intracranial or subcutaneous implants;\n2. Significant systemic disease that could increase study risk or interfere with trial participation;\n3. Neurological disorders other than Parkinson's disease;\n4. Major psychiatric disorder or severe depression or anxiety;\n5. History of deep brain stimulation surgery;\n6. Inability or unwillingness to complete all interventions and assessments.",{"count":142,"type":24},40,[64],"This clinical trial will evaluate the efficacy of accelerated Temporal Interference Stimulation (TIS) as a therapeutic intervention for individuals diagnosed with Parkinson's disease. Different frequency TIS will be delivered targeting the bilateral subthalamic nuclei of the brain according to the patient's clinical symptoms. Specifically, the basal thalamic nuclei on the side opposite to the side where the patient's symptoms are most severe receive stimulation at 130 Hz, whilst those on the other side receive stimulation at 60 Hz. The primary objective is to assess whether accelerated TIS yields measurable improvements in motor performance and verbal speech function among enrolled subjects. Functional magnetic resonance imaging (fMRI) will be adopted as an auxiliary imaging modality to objectively characterize underlying cerebral functional alterations induced by accelerated TIS intervention. The core scientific research questions to be addressed in this trial are listed as follows:\n\nWill different frequency accelerated TIS administered to the bilateral subthalamic nuclei produce significant improvements in motor function and cognitive function among enrolled subjects with Parkinson-related disorders? What quantitative and qualitative modifications in cerebral functional activity will be detected via fMRI after standardized accelerated TIS intervention administration? Investigators will implement a two-arm parallel controlled comparative design for all enrolled eligible subjects. This design remains a parallel design, with two independent groups of subjects receiving different active interventions simultaneously rather than a sham control. All confirmed Parkinson's disease patients will undergo standardized random grouping and be allocated into two independent research arms. Subjects in the experimental arm will receive continuous, standardized TIS intervention targeting bilateral subthalamic nuclei, with the basal thalamic nuclei on the side opposite to the side where the patient's symptoms are most severe receiving stimulation at 130 Hz, and those on the other side receiving stimulation at 60 Hz. Subjects in the control arm will receive continuous, standardized TIS intervention targeting bilateral subthalamic nuclei with bilateral 130 Hz stimulation. The control intervention adopts identical operation procedures, equipment wearing mode and on-site operating environment as the formal TIS intervention, with the only difference being the stimulation frequency setting (bilateral 130 Hz in the control arm versus asymmetric frequency in the experimental arm). Rigorous controlled grouping design will ensure objective, verifiable data support for verifying the actual intervention efficacy of different frequency TIS modes on motor dysfunction and speech impairment in Parkinson-related patients, and will also help to clarify the potential advantages of asymmetric frequency TIS over bilateral same-frequency TIS.\n\nAll enrolled subjects will complete the following standardized trial procedures in full compliance with the trial protocol:\n\nReceive continuous targeted intervention of either formal asymmetric frequency TIS (130 Hz on the contralateral side of severe symptoms, 60 Hz on the ipsilateral side) or bilateral 130 Hz TIS control intervention on bilateral subthalamic nuclei, with consecutive 5-day fixed-course administration in strict accordance with trial operating specifications.\n\nComplete unified fMRI brain scanning examinations and standardized motor function as well as speech function quantitative evaluation assessments at two fixed time nodes, including the baseline time point before intervention initiation and the follow-up time point after all intervention courses are completed.\n\nTruthfully record all adverse reactions and abnormal physical discomfort symptoms that occur throughout the whole intervention and follow-up observation cycle in standardized adverse event registration forms.",[28],{"date":99,"type":42},{"date":148,"type":24},"2026-07-20",{"date":150,"type":24},"2026-12-31",{"name":152,"class":49},"Ke Dong, MD",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":18,"sex":19,"minAge":88,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":62,"phases":164,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":133},"100643640","early-phase-1-test-retest-trial-with-11cmodag-005-in-pd-or-msa-and-amhc---pilot-phase-100643640","NCT07640542","Test-retest Trial With [11C]MODAG-005 in PD or MSA and AMHC - Pilot Phase","An Open-label, Single-center Study to Evaluate the Safety and Test-retest Characteristics of [11C]MODAG-005 as PET Radioligand for Imaging Pathological Alpha-synuclein Deposition in the Brains of Patients With Parkinson's Disease (PD) or Multiple System Atrophy (MSA) Compared to Age-matched Healthy Controls (AMHC) - Pilot Phase","PIOSA","Inclusion Criteria:\n\n* Key inclusion criteria: Patients with MSA fulfilling both the criteria for probable MSA (Gilman et al., 2008) and clinically established MSA (Wenning et al., 2022), patients with PD fulfilling the criteria for clinically established PD (Postuma et al., 2015) or age-matched healthy controls (AMHC).\n\nExclusion Criteria:\n\n1. Laboratory tests with clinically significant abnormalities and\u002For clinically significant unstable medical illness equivalent to CTC v5.0 (common toxicity criteria) toxicities greater than grade 2.\n2. Evidence of clinically significant disease that is expected to interfere with cognitive assessments or the ability to complete the trial procedures as judged by the investigator.\n3. Clinically significant renal and hepatic dysfunction as judged by the investigator.\n4. Known hypersensitivity to the active substance or to any of the excipients of \\[11C\\]MODAG-005 solution for injection.\n5. Known hypersensitivity to the active substance or to any of the excipients in anle138b (Emrusolmin) capsules.\n6. Participant has received an investigational drug within 3 months of screening.\n7. Blood donations within 7 days before enrolment.\n8. Pregnant (see 9.1.5) or breast-feeding or having the intention of getting pregnant. Female participants of childbearing potential and male participants with female partners of childbearing potential not willing to practice effective contraception during the trial period and for 90 days following each PET\u002FCT scan.\n9. Unsuitable veins for repeated venipuncture.\n10. Contraindication to blood sampling and\u002For arterial cannulation, including but not limited to allergy to local anesthetics, peripheral vascular disease, Raynaud's phenomenon as determined by abnormal Allen's test on both arms or abnormal coagulation profile at screening. If Allen's test should be \"abnormal\" on both arms, the participant will not be eligible for arterial sampling, but will participate in the remaining assessments.\n11. MRI exclusion criteria include but not limited to: findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct \\>1 cm\\^3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the Fluid-Attenuated Inversion Recov ery (FLAIR) sequence that is \\>20 mm in any dimension), infectious disease, space-occupying lesions normal pressure hydrocephalus or any other abnormalities associated with central nervous system (CNS) disease. Findings that are expected to be present in the PD and MSA participants (e.g. absence of swallow tail sign, presence of regional atrophy or hot cross bun sign) do not lead to exclusion of these participants.\n12. Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.\n13. Unwilling and\u002For unable to cooperate with trial procedures.\n\n    Exclusion criteria for age-matched healthy controls:\n14. Relevant hepatic parameters above upper limit of normal (ULN), i.e., glutamic pyruvic transaminase (GPT), glutamic oxaloacetic transaminase (GOT), bilirubin\n15. Relevant renal parameters outside normal limits, i.e., serum creatinine and blood urea nitrogen (BUN) above ULN; urinary albumin-creatinine ratio (uACR) below lower limit of normal (LLN)\n16. Systolic blood pressure \\\u003C90 or \\>140 mmHg; diastolic blood pressure \\\u003C45 or \\>90 mmHg; heart rate \\\u003C50 or \\>95 beats per minute (BPM)","75 Years",{"count":163,"type":24},9,[165],"EARLY_PHASE1","This is an open-label, single-center Phase 1 study evaluating the safety, tolerability, and test-retest characteristics of \\[11C\\]MODAG-005, an investigational positron emission tomography\u002Fcomputed tomography (PET\u002FCT) radioligand intended to image pathological alpha-synuclein deposition in the brain. The study will enroll participants with Parkinson's disease (PD), participants with multiple system atrophy (MSA), and age-matched healthy controls (AMHC).\n\nParticipants with PD or MSA will undergo two \\[11C\\]MODAG-005 PET\u002FCT imaging sessions: one baseline scan and one follow-up scan 7 to 48 days later. Age-matched healthy controls will undergo one baseline scan. A subset of PD and MSA participants will receive a single oral dose of anle138b (Emrusolmin) before the second scan to evaluate tracer uptake under blocking conditions. The primary objective is to assess the safety and tolerability of \\[11C\\]MODAG-005. Secondary objectives include evaluating whether \\[11C\\]MODAG-005 PET imaging can distinguish participants with MSA or PD from age-matched healthy controls, distinguish PD from MSA, and determine test-retest variability of PET outcome measures.",[28,168,169],"MSA - Multiple System Atrophy","Healthy Adult Participants",[171,172,173,174,175],"MODAG","MODAG GmbH","Synuclein","Neurodegeneration","Lewy Body","2026-07-30",{"date":178,"type":42},"2026-07-31",{"date":180,"type":42},"2026-07-29",{"date":182,"type":24},"2027-07",{"name":172,"class":184},"INDUSTRY",{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":19,"minAge":88,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":62,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":209,"locationsCount":133},"100615948","remote-ischemic-conditioning-for-sleep-disturbances-and-other-non-motor-symptoms-in-parkinsons-disease-100615948","NCT07299240","Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease","Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease: a Randomized, Single-blind, Sham-controlled Clinical Study","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria.\n* Age between 50 and 70 years.\n* Disease duration ≤ 5 years.\n* Hoehn and Yahr stage I-III in the \"on\" state.\n* Presence of insomnia that meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria and clinically significant sleep complaints (for example, Parkinson's Disease Sleep Scale-2 \\[PDSS-2\\] total score ≥ 18 points).\n* On a stable regimen of antiparkinsonian medications for at least 4 weeks prior to enrollment, with no expected dose changes during the study period.\n* Able to understand the study procedures and provide written informed consent (or consent provided by a legally authorized representative when appropriate).\n\nExclusion Criteria:\n\n* Secondary insomnia due to other severe medical conditions (e.g., uncontrolled cardiopulmonary, hepatic, renal, or endocrine diseases).\n* Current psychotic symptoms or severe anxiety or depression (e.g., Hamilton Anxiety Scale score ≥ 14 or Hamilton Depression Scale score ≥ 17).\n* Other primary sleep disorders such as moderate-to-severe obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder, or rapid eye movement sleep behavior disorder that require specific treatment.\n* History of significant cerebrovascular disease, brain tumor, central nervous system infection, or other neurological disorders that may interfere with sleep or study assessments.\n* Contraindications to remote ischemic conditioning (RIC), including severe peripheral arterial disease of the upper limbs, local soft tissue infection or damage at the cuff site, subclavian artery thrombosis, malignant hypertension, severe cardiac disease, active bleeding disorders, or other conditions judged unsafe by the investigator.\n* Contraindications to MRI or EEG examinations (e.g., pacemaker, severe claustrophobia, metallic implants incompatible with MRI).\n* Participation in another interventional clinical trial within the past 3 months.\n* Inability to comply with the study procedures or follow-up visits, as judged by the investigator.","70 Years",{"count":194,"type":24},48,[64],"This single-center, randomized, single-blind, sham-controlled clinical trial aims to evaluate whether remote ischemic conditioning (RIC) can improve sleep disturbances and other non-motor symptoms in patients with Parkinson's disease (PD). Forty-eight PD patients with insomnia will be randomly assigned in a 1:1 ratio to receive either active RIC (cuff inflation to high pressure) or sham RIC (cuff inflation to low pressure) for 7 consecutive days, in addition to their standard antiparkinsonian medications. Subjective sleep scales, sleep diaries, validated rating scales for motor and non-motor symptoms, and overnight polysomnography will be used to assess treatment effects at baseline, after the 7-day intervention, and during short-term follow-up. The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers.",[28,198],"Insomnia",[200,35,201,202],"remote ischemic conditioning","insomnia","non-motor symptoms","2026-07-25",{"date":205,"type":42},"2026-07-28",{"date":207,"type":42},"2026-01-01",{"date":150,"type":24},{"name":210,"class":49},"Jiangsu Province Nanjing Brain Hospital",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":21,"enrollmentInfo":218,"targetDuration":4,"studyType":62,"phases":220,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":133},"100648634","phase-2-phase-iib-clinical-trial-to-evaluate-the-efficacy-and-safety-of-vg081821ac-tablets-in-patients-with-early-to-mid-stage-parkinsons-disease-100648634","NCT07725562","Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of VG081821AC Tablets in Patients With Early to Mid-stage Parkinson's Disease","A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of Oral VG081821AC Tablets Monotherapy (Without Concomitant Levodopa) in Patients With Early to Mid-Stage Parkinson's Disease","Inclusion Criteria:\n\n(1). Male or female aged 18 ≤ Age ≤ 80 at the time of signing the informed consent. (2). Diagnosed with Parkinson's disease per the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), and time from initial diagnosis ≤ 7 years. (3). Modified Hoehn-Yahr scale rated as 1\\~3 (inclusive) at screening. (4). MDS-UPDRS Part III score ≥ 22 at screening. (5). Have not taken anti-Parkinson drugs containing levodopa within 4 weeks prior to screening \\[see main text section 5.7.1\\] (Note: Patients who have previously taken levodopa-containing anti-Parkinson drugs can participate in this trial after a 4-week washout period). (6). Patients receiving amantadine and\u002For anticholinergic drugs prior to screening must have been on a stable treatment regimen for at least 4 weeks prior to screening, and the dose must not change during the study. (7). Women of childbearing potential must have a negative pregnancy test result at screening, and the participant must agree to use approved contraceptive measures throughout the study period. (8). Must provide written informed consent and be willing and able to comply with the trial protocol (e.g., able to understand and complete questionnaires, follow the visit schedule, and use the medication).\n\nExclusion Criteria:\n\n(1). Presence of any medical condition that may interfere with full participation in the study, including but not limited to the following: current diagnosis of active epilepsy; history of hemolytic anemia, pulmonary embolism, respiratory depression, dementia, active psychiatric disease, severe depression, or malignant tumor. (2). History of congestive heart failure (New York Heart Association functional class 3 or 4) or known left ventricular ejection fraction \\\u003C30%. (3). History of angina pectoris, myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, peripheral arterial bypass surgery, transient ischemic attack (TIA), or stroke within 3 months prior to screening. (4). History of arrhythmia or presence of uncontrolled arrhythmia, including but not limited to: atrial fibrillation, Wolff-Parkinson-White syndrome, congenital long QT syndrome, and ECG indicating QTc interval prolongation (defined as male (QTc) \\> 450 ms, female (QTc) \\> 470 ms); \\[Fridericia formula: QTc=QT\u002F(RR\\^0.33), where RR represents the standard heart rate value, calculated by dividing 60 by the heart rate\\]. (5). Use of dopamine receptor agonists, monoamine oxidase inhibitors, catechol-O-methyltransferase (COMT) inhibitors, adenosine A2A receptor antagonists, or drugs with dopamine receptor antagonist effects within 4 weeks prior to screening \\[see main text section 5.7.1\\]. (Note: For newly diagnosed patients undergoing an acute dopaminergic challenge test-i.e., taking a single dose of levodopa \\[e.g., Madopar\\] or dopamine agonist \\[e.g., Apomorphine\\]-they can be enrolled after a 3-day washout period). (6). History of drug or other allergies where the investigator considers participation in this study to be of high risk, or previous allergic reactions to adenosine A2A receptor antagonists, or suspected by the investigator to be allergic to the study drug or any of its components. (7). Plan to take drugs that are inhibitors or inducers of efflux transporters (P-gp, BCRP) during the study period. (8). Suffering from uncontrolled hypertension (treated or untreated) at screening, defined as systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg. (Note: After establishing good blood pressure control within a reasonable timeframe, the investigator may permit re-measuring of blood pressure up to the baseline visit, at their discretion). (9). Presence of clinically significant hepatic impairment (defined as total bilirubin and\u002For direct bilirubin, alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) above the upper limit of the reference range, and deemed clinically significant by the investigator). (10). Presence of any of the following: positive Hepatitis B surface antigen; positive Hepatitis C virus antibody; positive Hepatitis E virus antibody; positive Human Immunodeficiency Virus (HIV) test; positive Treponema pallidum test. (11). Previous non-response to high-dose levodopa (excluding cases of malabsorption) or previous non-response to adequate dopaminergic therapy. (12). Presence of clinically significant renal impairment (creatinine clearance Ccr \\\u003C30mL\u002Fmin), calculated at screening using the Cockcroft-Gault formula: Ccr (mL\u002Fmin) = (140 - Age) × Weight (kg) \u002F \\[72 × Serum Creatinine (SCr) (mg\u002FdL)\\] (Female × 0.85) or Ccr (mL\u002Fmin) = (140 - Age) × Weight (kg) \u002F \\[0.814 × Serum Creatinine (SCr) (μmol\u002FL)\\] (Female × 0.85). (13). Investigator judges the participant to be at risk for suicide, or if the participant answers \"yes\" to Question 4 and\u002For Question 5 of the Suicidal Ideation subscale, or any question on the Suicidal Behavior subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening. (14). Investigator judges the participant to have severe psychiatric abnormalities (anxiety, depression), with a Hamilton Depression Rating Scale-17 (HAMD-17) score \\>23, or a Hamilton Anxiety Rating Scale (HAMA) score \\>21 at screening. (15). Participant has significant cognitive impairment or dementia, including the following scenarios: Illiterate participants (uneducated) with an MMSE score ≤19 at screening; Primary school participants (education ≤6 years) with an MMSE score ≤22 at screening; Middle school and above participants (education \\>6 years) with an MMSE score ≤23 at screening. (16). History of surgical treatment for Parkinson's disease. (17). Use of repetitive transcranial magnetic stimulation, transcranial direct current stimulation, biofeedback therapy, acupuncture, traditional Chinese medicine, and other traditional rehabilitation methods within 4 weeks prior to screening (Note: Patients can participate in this trial after a 4-week washout period). (18). History of heavy alcohol consumption for more than 3 consecutive months within 1 year prior to screening, defined as: female participants drinking an average of \\>20 g of alcohol daily (calculated as pure alcohol; 20 g is roughly equivalent to two 300 mL glasses of beer, 40 mL of spirits, or 140 mL of wine), and male participants drinking an average of \\>30 g of alcohol daily (calculated as pure alcohol; 30 g is roughly equivalent to three 300 mL glasses of beer, 60 mL of spirits, or 210 mL of wine), or inability to reliably quantify alcohol consumption according to the investigator's judgment. (19). History of excessive tea and\u002For coffee consumption within the past 4 weeks, or anticipated excessive consumption during the clinical trial period. (Excessive tea consumption is defined as 4 or more cups a day, 1 cup = 250 mL; second or third steepings without adding new leaves still count as 1 cup total, not two or three. Excessive coffee consumption is defined as 2 or more cups a day, 1 cup = 250 mL; for participants who do not drink coffee every day, 2 cups per day is permissible for one day a week, but no more than 2 cups; and the defined consumption limit must not be exceeded throughout the entire trial). (20). Active substance abuse (including inhaled or injected drugs) within 1 year prior to screening. (21). Participated in another drug clinical trial (meaning received investigational drug treatment) within 3 months prior to randomization. (22). Any other condition where the investigator considers the participant unsuitable for this study.",{"count":219,"type":24},152,[221,120],"PHASE2","This study is testing a new oral medication called VG081821AC to see if it can help improve movement symptoms in people with early to mid-stage Parkinson's disease. VG081821AC works by blocking a protein in the brain called the adenosine A2A receptor, which may help improve motor function without using levodopa. The main goal is to measure changes in movement symptoms using a standard rating scale called the MDS-UPDRS Part III (Motor Examination). This scale evaluates how well participants can move, walk, and perform daily activities. The study will compare the scores before and after 12 weeks of treatment to see if VG081821AC improves movement symptoms better than the placebo. Currently, levodopa is the most common treatment for Parkinson's disease, but it can cause side effects over time. If VG081821AC works well, it could offer a new treatment option for people in the early to mid-stages of Parkinson's disease who want to delay or avoid starting levodopa. A total of 152 adults (aged 18-80 years) will be enrolled in this trial in China. Participants will be randomly assigned (like flipping a coin) to one of four groups:\n\n* VG081821AC 25 mg (taken twice daily)\n* VG081821AC 50 mg (taken twice daily)\n* VG081821AC 75 mg (taken twice daily)\n* Placebo (a pill with no active drug, taken twice daily)\n\nParticipants will visit the study center 8 times to have their movement symptoms, safety, and overall health checked.",[28],[225,226,227,228,229,230,231],"A2A receptor antagonist","Adenosine A2A antagonist","VG081821AC","VG081821","KW6002","Istradefylline","Nourianz",{"date":233,"type":42},"2026-07-24",{"date":235,"type":42},"2026-07-17",{"date":237,"type":24},"2027-10-31",{"name":239,"class":184},"Zhejiang Vimgreen Pharmaceuticals, Ltd.",{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":19,"minAge":88,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":248,"conditions":249,"keywords":253,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100647301","artificial-intelligence-based-parkinsons-disease-risk-assessment-ai-pra-study-100647301","NCT07706829","Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study","AI-PRA","Inclusion Criteria:\n\n1. Age ≥ 50 years.\n2. At least one of the following clinical markers for PD risk:\n\n   1. REM sleep behaviour disorder (RBD) confirmed with polysomnography.\n   2. Neurogenic orthostatic hypotension (nOH) defined as a drop in systolic \u002F diastolic blood pressure ≥ 20\u002F10mmHg within 3 minutes of active standing or tilt-table test, and with a blunted heart rate response (ΔHeart rate\u002FΔSBP ratio \\\u003C 0.5 bpm\u002FmmHg).\n   3. Objective hyposmia defined as University of Pennsylvania Smell Identification Test (UPSIT) score ≤ 15th percentile for age and sex.\n3. Able and willing to give informed written consent.\n4. Use of compatible smartphone (mobile operating system Android version 11 or newer). A smartwatch will be provided to each participant for the duration of the study.\n\nExclusion Criteria:\n\n1. Clinical diagnosis of Parkinson's disease (PD) according to MDS clinical diagnostic criteria.\n2. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of investigator).\n3. Dementia defined as deterioration of cognitive function severe enough to impair functioning on daily activities.\n4. Active treatment with neuroleptics, reserpine or metoclopramide (these drugs should be discontinued for at least 6 months before screening visit) due to their interference with dopamine transporter SPECT imaging acquisition and interpretation.\n5. Pregnant women.\n6. Concomitant participation in interventional studies.\n7. Unwilling or unable to give informed written consent.\n8. Vulnerable individuals as defined by the HRA.\n9. Inability to use the smartwatch and\u002For the mAI-Health app for the purpose of the study as judged by the investigator.",{"count":118,"type":24},"The study aims to provide initial proof-of-concept validation data of an artificial intelligence-based model to estimate individual Parkinson's disease risk using demographic, clinical, genetic information and digital biomarker data collected via a smartwatch and a mobile application.",[28,250,251,252],"REM Sleep Behavior Disorder (iRBD)","Neurogenic Orthostatic Hypotension","Hyposmia",[254,255,256,257,258,259,260,261],"prodromal Parkinson's disease","neurogenic orthostatic hypotension","REM sleep behaviour disorder","hyposmia","Digital biomarkers","AI-PROGNOSIS","Smartwatch","Wearable electronic devices","2026-07-16",{"date":148,"type":42},{"date":265,"type":24},"2026-07-01",{"date":267,"type":24},"2027-09-30",{"name":269,"class":49},"Queen Mary University of London",3,{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":277,"targetDuration":4,"studyType":62,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":4},"100644659","probing-gut-brain-communication-in-parkinsons-disease-100644659","NCT07673146","Probing Gut-Brain Communication in Parkinson's Disease","Inclusion Criteria:\n\n* Aged ≥21 years old and ≤80 years old\n* Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria\n* Adequate visual, hearing, cognitive, and physical ability\n\nExclusion Criteria:\n\n* Diagnosis of secondary or atypical parkinsonism\n* Laboratory Values: a: Hemoglobin (Hgb) \\\u003C10; b: Platelets \\\u003C70,000; c: Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \\> 2 1\u002F2 times upper limit of normal (ULN); d: 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); e: Significantly above the normal range for PT\u002FINR\u002FPTT.\n* Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score 35 kg\u002Fm2 or body weight\n* 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\n* 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\n* Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated cutaneous squamous or basal cell carcinomas are not excluded.)\n* 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\n* Body weight \\> 400lbs (limit of the MRI table)\n* Participant is currently pregnant, breastfeeding, and\u002For lactating\n* History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)\n* History of Covid-19 (SARS-CoV-2) infection within 6 weeks prior to screening.\n* 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\n* 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.\n* History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate).\n* Use of medications that impact the microbiota including antibiotics during the 4 weeks prior to enrollment\n* Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly)\n* Endorses any contraindications to MRI (see risks section of protocol for full list of MRI exclusions)\n* Allergic to pineapple",{"count":278,"type":24},45,[64],"Administering transcutaneous vagus nerve stimulation in patients with Parkinson's disease to see how it affects stomach and brain activity.",[28],"2026-06-30",{"date":284,"type":42},"2026-07-02",{"date":286,"type":24},"2026-08-01",{"date":288,"type":24},"2031-07-01",{"name":290,"class":49},"Spaulding Rehabilitation Hospital",{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":161,"enrollmentInfo":297,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":299,"conditions":300,"keywords":301,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":133},"100645245","the-effect-of-bottle-pep-exercise-on-expiratory-muscle-thickness-strength-and-balance-parameters-in-parkinsons-disease-patients-100645245","NCT07680725","The Effect of Bottle PEP Exercise on Expiratory Muscle Thickness, Strength, and Balance Parameters in Parkinson's Disease Patients","Inclusion Criteria:\n\n* Patients with a confirmed Parkinson's diagnosis who are being monitored\n* Those aged 18-75\n* Patients who are ambulatory\n\nExclusion Criteria:\n\n* Patients with acquired primary motor neuron disease (ischemic\u002Fhemorrhagic stroke, intracranial mass) and additional neurological diagnoses\n* Patients with hearing and cognitive impairments that prevent them from understanding or performing the exercise program\n* Presence of concomitant acute or chronic lung disease\n* History of thoracic or abdominal surgery\n* Severe heart disease\n* Active cancer\n* Mini-Mental State Examination (MMSE) score ≤ 24\n* Active smoking",{"count":298,"type":24},42,"Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by rigidity, tremor, postural instability, bradykinesia, and autonomic dysfunction. It is a common movement disorder worldwide. Motor impairments in PD patients are not limited to the muscles of the extremities; the neck, upper respiratory tract, and respiratory muscles are also affected. The resulting pulmonary dysfunction is one of the main factors contributing to morbidity and mortality in PD patients.\n\nRespiratory muscle exercise programs have been used to improve lung and swallowing function in patients with Parkinson's disease and other similar neurodegenerative disorders. Studies of inspiratory muscle exercise in Parkinson's patients have reported improvements in inspiratory muscle strength and endurance. Similarly, expiratory muscle exercise protocols have been shown to increase maximum expiratory pressure (MEP) and cough effectiveness. However, studies on expiratory muscle strengthening are lacking in the literature.\n\nPositive expiratory pressure (PEP) devices are used to clear airway secretions and feature a resistance that provides resistance during exhalation. This creates a positive pressure that stabilizes the airways during exhalation and prevents airway collapse. Although there are many PEP devices available on the market, the bottle-PEP, a therapist-made device, is used because it can be produced easily and at low cost. The bottle-PEP device consists of a bottle filled with at least 10 cm of water and a tube placed inside the bottle. Although information on strengthening expiratory muscles is traditionally found in the literature, there is no data in the literature on the effect of bottle-PEP use on expiratory muscle strength, especially in Parkinson's patients. A review of the literature shows that the effect of expiratory strengthening on balance has not been studied before.\n\nThis study aimed to demonstrate the effects of the bottle-PEP device, used in addition to expiratory muscle strengthening, on expiratory muscle thickness, strength, and balance.",[28],[302,69,303,304,305,306,307],"Parkinson","diaphragm thickness","inspiratory muscle","respiratory exercises","bottle-PEP","balance","2026-06-29",{"date":284,"type":42},{"date":311,"type":42},"2025-10-01",{"date":313,"type":24},"2026-11-01",{"name":315,"class":49},"Marmara University",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":62,"phases":326,"briefSummary":327,"conditions":328,"keywords":330,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":133},"100606494","phase-2-18f-mfbg-cardiac-uptake-with-lewy-body-dementia-100606494","NCT07176286","18F-mFBG Cardiac Uptake With Lewy Body Dementia","An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With and Without Lewy Body Diseases","IRP101-231","Inclusion Criteria:\n\n* 1\\. ≥18 years of age at study entry. 2. Able and willing to comply with study procedures and signed and dated informed consent is obtained.\n\n  3\\. A male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and\u002For hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a serum pregnancy test performed at screening is negative.\n\n  4\\. All subjects: Judged clinically stable for at least 30 days before enrolment into the study and remains stable to the time of the study imaging procedure.\n\nFor Lewy body disease subjects (Study Cohort I):\n\n5\\. The subject has a diagnosis of either PD or DLB based on accepted clinical criteria at least 6 months before enrollment into the study.\n\nFor non-Lewy body disease subjects (Study Cohort II):\n\n6\\. The subject has a diagnosis of neurological or neurodegenerative disease for which neither PD nor DLB is judged likely by a neurologist based on accepted clinical and imaging criteria.\n\nExclusion Criteria:\n\n* 1\\. Previously entered into this study or has participated in any other investigational product or medical device study within 30 days of enrollment.\n\n  2\\. History or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.\n\n  3\\. Presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 1 year or where participation in the study might compromise the management of the subject or other reason that in the judgment of the investigator(s) makes the subject unsuitable for participation in the study.\n\n  4\\. Documented ischemic heart disease (prior myocardial infarction, unstable angina, etc) or a diagnosis of heart failure of ischemic or non-ischemic etiology.\n\n  5\\. Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma.\n\n  6\\. The subject is claustrophobic or has a movement disorder that prevents him\u002Fher from lying still in a supine position for up to 20 minutes.\n\n  7\\. Renal insufficiency (serum creatinine \\>3.0 mg\u002FdL). 8. Uses medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures.\n\n  9\\. Participated in a research study using ionizing radiation in the previous 12 months such that participation in the study might result in a total effective dose from research procedures exceeding 50 milliSieverts during that time interval.",{"count":325,"type":24},20,[221],"This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.",[28,329],"Lewy Body Dementia (LBD)",[322,331],"18F-mFBG",{"date":265,"type":42},{"date":334,"type":42},"2026-04-30",{"date":336,"type":24},"2026-12-30",{"name":338,"class":184},"Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)",{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":19,"minAge":88,"maxAge":21,"enrollmentInfo":346,"targetDuration":4,"studyType":62,"phases":348,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":133},"100646935","l-theanine-and-mediterranean-diet-on-rbd-gi-function-and-inflammation-in-parkinsons-disease-100646935","NCT07682532","L-THEANINE AND MEDITERRANEAN DIET ON RBD, GI FUNCTION, AND INFLAMMATION IN PARKINSON'S DISEASE","THE EFFECT OF L-THEANINE SUPPLEMENTATION ON REM SLEEP BEHAVIOR DISORDER, GASTROINTESTINAL FUNCTION, AND INFLAMMATORY MARKERS IN PARKINSON'S DISEASE","Inclusion Criteria:\n\nPatients diagnosed with Parkinson's Disease and classified as stage 1 according to the Hoehn-Yahr Staging (HYA), Patients without communication impairment (aphasia) Participants who sign the Informed Consent Form and volunteer to participate in the study Absence of dementia and Mini Mental State Examination (MMSE) score \\> 24 Living in the same household with a healthy spouse\u002Fpartner Not taking prebiotic, fiber, probiotic, herbal, or high-dose vitamin or mineral supplements that may affect inflammation during the pre-onset period and throughout the study protocol\n\nExclusion Criteria:\n\nPatients with a history of severe heart, lung, liver, or kidney failure, primary psychiatric, developmental, or other neurological disease Patients using sedative\u002Fhypnotic medications Individuals consuming more than 200 mg of caffeine per day (approximately 2-3 cups of tea or 1 cup of coffee) Patients who smoke and consume alcohol Having undergone surgery related to bowel health Having a chronic infectious bowel disease Having a congenital bowel anomaly Using probiotics, antifungals, and\u002For antibiotics within the last three months Individuals with an autoimmune disease or weakened immune system Self-reported alcohol or drug use within the last 3 months Current use of over-the-counter medications, supplements, foods, and\u002For beverages that may affect stress, sleep, cognition, and\u002For mood Inability to swallow the study supplement due to swallowing anxiety Receiving treatment for a GI disease or condition diagnosed by a doctor other than constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease Positive results for human immunodeficiency virus (HIV) or Hepatitis B\u002FC. Current history of active conditions of inflammatory bowel disease, irritable bowel syndrome, colitis, celiac disease, short bowel syndrome, colostomy, colectomy, gastrointestinal fistula, or strictures.\n\nRecent or current use of any antibiotic (within 4 weeks prior to the start of the study) Use of enemas or suppositories to relieve constipation Good adherence to the Mediterranean diet in the pre-start period according to the 14-item Mediterranean Diet Assessment Tool (score \\>6)",{"count":347,"type":24},52,[64],"Parkinson's disease is a progressive neurological disorder associated with severe dopaminergic neuron loss in the substantia nigra pars compacta. The decrease in dopamine cells in the gut in Parkinson's disease negatively affects bowel movements, and constipation is a common condition. Impairment of the intestinal barrier increases inflammation. Reactive oxygen species increase, and intestinal homeostasis changes. Alpha-synuclein levels increase in the gut. L-theanine is the most abundant amino acid in green tea leaves. Parkinson's patients exhibit increased oxidative stress along with decreased activity of glutathione peroxidase, superoxide dismutase, and catalase. L-theanine is believed to increase the activity of these enzymes and reduce oxidative stress. L-theanine administration has been found to increase total short-chain fatty acids in stool. Furthermore, it is suggested that L-theanine inhibits imbalances in oxidative stress and inflammatory responses by reducing inflammatory factors such as TNF-α, IL-6, and IL-1β. REM sleep disturbance is also a common problem in Parkinson's disease. Studies have shown that following L-theanine treatment, participants' Pittsburgh Sleep Quality Index (PSQI) scale scores improved. The gut microbiota regulates sleep and neurological states via the microbiota-gut-brain axis. L-theanine supplementation appears to be able to regulate gut bacterial composition to suppress neurotransmitters, cytokines, and other metabolites to regulate sleep. The protective effects of L-theanine administration on increased dopamine and other neurotransmitters, microbiota, sleep, and antioxidant enzymes may offer a glimmer of hope regarding its beneficial role in Parkinson's disease.",[28],[35,352,353,354],"REM sleep behavior disorder","inflammation","nutrition","2026-06-28",{"date":357,"type":42},"2026-07-06",{"date":359,"type":42},"2026-05-02",{"date":361,"type":24},"2026-10-20",{"name":363,"class":49},"Medipol University",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":19,"minAge":59,"maxAge":161,"enrollmentInfo":372,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":4},"100644798","outlining-biological-effects-of-subthalamic-deep-brain-stimulation-in-parkinsons-disease-patients-100644798","NCT07673783","Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients.","Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients: Insights Into Fluid Biomarkers of Neuroinflammation and Correlations With Clinical Outcomes","BRAIN-DBS-GAIN","Inclusion Criteria:\n\n* clinically established diagnosis of PD according to the criteria of the Movement Disorder Society (MDS) (Postuma et al., Mov Disord 2015);\n* a minimum disease duration of 4 years;\n* eligibility for STN-DBS surgery according to Core Assessment Program for Surgical Interventional Therapies in PD (Defer et al., Mov Disord 1999);\n* age between 18 and 75 years.\n\nExclusion Criteria:\n\n* inability to express an informed consent;\n* moderate or severe cognitive impairment (score \\\u003C 24 on the Mini-Mental State Examination);\n* severe psychiatric symptoms (e.g., psychosis, major depression);\n* previous neurosurgical interventions for PD;\n* pregnancy;\n* ongoing inflammatory or autoimmune diseases;\n* chronic infectious diseases;\n* active neoplasms;\n* chronic intake of anti-inflammatory drugs (e.g. steroids or NSAIDs).",{"count":373,"type":24},90,"The aim of the study is to characterize the neuroinflammatory effects of subthalamic deep brain stimulation in patients with Parkinson's disease, by analyzing changes in blood neuroinflammatory and neurodegenerative biomarkers before and after surgery (at 6 and 12 months, respectively), and comparing the changes in blood biomarkers levels with a control group of patients with advanced PD on best medical treatment.",[28],"2026-06-23",{"date":308,"type":42},{"date":379,"type":24},"2026-09-01",{"date":381,"type":24},"2028-02-29",{"name":383,"class":49},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":19,"minAge":391,"maxAge":21,"enrollmentInfo":392,"targetDuration":4,"studyType":62,"phases":394,"briefSummary":395,"conditions":396,"keywords":402,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"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.","40 Years",{"count":393,"type":24},34,[64],"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.",[29,28,397,398,399,400,401],"Parkinson s Disease","Postural Instability","Postural Instability Gait Disorders","Gait Disorders","Cognitive Dysfunction, Cognitive Disorder",[403,398,400,404,405,406],"Parkinson Disease","Cognitive Dysfunction","Dual Task","Virtual Reality",{"date":408,"type":42},"2026-06-25",{"date":410,"type":24},"2026-06-20",{"date":412,"type":24},"2027-12-30",{"name":414,"class":49},"Bezmialem Vakif University",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":19,"minAge":88,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":62,"phases":425,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":133},"100641859","passive-versus-active-music-therapy-parkinsons-disease-100641859","NCT07661524","Passive Versus Active Music Therapy Parkinson's Disease","Effects of Active Versus Passive Music Therapy on Functional Ability and Psychophysiological Responses to Goal-Directed Exercise in People With Parkinson's Disease","Inclusion Criteria:\n\n* Formal diagnosis of idiopathic PD\n* Hoen \\& Yahr Stage \\\u003CIII\n* Middle or old age onset of PD (at least 50 years of age)\n* The ability to ambulate without assistive devices\n* Stable medication regimen for four weeks prior to participation\n* No changes to treatment of PD in the last month.\n\nExclusion Criteria:\n\n* Primary psychiatric disease (non-PD related)\n* Reports of falling in the last six weeks\n* Any reason a participant or their healthcare team believed their participation in the study could negatively impact their well-being.","89 Years",{"count":424,"type":24},28,[64],"The purpose of this pilot study is to identify the effects of active versus passive music therapy on functional ability and psychophysiological responses to goal-directed exercise in people with Parkinson's disease.",[28],[429,430,431,432,174],"Music therapy","Exercise","Motivation","Parkinson's","2026-06-16",{"date":435,"type":42},"2026-06-22",{"date":437,"type":24},"2026-08",{"date":439,"type":24},"2027-08",{"name":441,"class":49},"University of Alabama at Birmingham",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":19,"minAge":449,"maxAge":192,"enrollmentInfo":450,"targetDuration":4,"studyType":62,"phases":452,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":270},"100636929","phase-1-safety-and-feasibility-of-bilateral-striatal-transplantation-of-dopacell-in-parkinsons-disease-100636929","NCT07572071","Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease","Evaluation of the Safety and Feasibility of a Single Transplantation of 10 Million Human Embryonic Stem Cell-Derived Dopaminergic Progenitor Cells Into the Bilateral Striatum of Patients With Moderately Severe Parkinson's Disease: a Multicenter, Open-label, Single-arm Phase I Clinical Trial","Inclusion Criteria:\n\n* Age: 30-70 years\n* Diagnosis of PD: MDS clinical Diagnostic Criteria for Parkinson's disease\n* The disease duration more than 5 years\n* Moderate Parkinson's disease, defined as a Hoehn and Yahr stage of 2 or 3 during the OFF period.\n* The patient is receiving oral pharmacological therapy, and in the opinion of the Principal Investigator, the patient's symptoms remain inadequately controlled despite optimal medical management, or the patient is experiencing adverse effects related to their current treatment\n* No history or only mild levodopa-induced dyskinesia, defined as a score of 2 or less on the UDysRS scale in any body region during the ON state.\n* The patient demonstrates a clinically meaningful response to a therapeutic dose of levodopa, as determined by the Principal Clinical Investigator or a trained specialist under the supervision of the Principal Investigator.\n* The performance of different organs based on laboratory evaluations:\n\n  * Number of neutrophils ≥2000 \u002F microliter\n  * Platelet count ≥100,000 \u002F microliter\n  * AST \u002F ALT: less than or equal to three times the maximum normal value at the intervention site\n  * Total bilirubin less than or equal to 1.5 times the maximum normal amount at the intervention site\n  * eGFR \\* rate: greater than or equal to 60 ml \u002F min \u002F 1.73 m2 \\* eGFR (mL \u002F min \u002F 1.73 m2) = 194 X Cr \\^ -1.094 X age \\^ -0.287 (X 0.739 for females)\n* Informed consent\n\nExclusion Criteria:\n\n* The abnormal function of immune system\n* The symptomatic brain injuries (brain atrophy, cerebral Infarct, trauma, vascular malformation) confirmed by brain MRI\n* Markedly reduced or normal signal in the ventral striatum on TRO-DaT SPECT imaging.\n* Any abnormal findings on brain MRI.\n* Positive GBA mutation test.\n* Diagnosis of dementia based on a MoCA score \\\u003C 24.\n* The abnormality of thrombotic system or high risk of bleeding\n* Positive for any of the following viral markers or active infections: HBsAg, HBsAb, HBcAb, anti-HIV antibodies, anti-HTLV-1\\&2 antibodies, active hepatitis C infection, syphilis, or active CMV, VZV, EBV, or COVID-19 infection.\n* Impossibility of MRI imaging for patients with metal in the body, pacemaker in the body, claustrophobia, with artificial heart valves that are incompatible with MRI or body weight is not within the tolerable range for MRI.\n* Patients with contraindications to the study drug: Tacrolimus, Prednisolone, Basiliximab, Cotrimoxazole, MRI contrast agent.\n* Patients undergoing other cell transplants, including embryonic stem cell-derived dopaminergic progenitor cells.\n* Patients with a history of PD at the same time and concurrent: Malignant neoplasm, epilepsy, cerebral hemorrhage or a positive history\n* Psychiatric disorders confirmed by a psychiatrist, including major depression, bipolar disorder, or schizophrenia, that are uncontrolled or treatment resistant.\n* Patients with intellectual disability who, in the judgment of a psychiatrist, are unable to fully comprehend the study requirements.\n* History of pallidotomy, thalamotomy, or deep brain stimulation (DBS).\n* Patients considered high-risk candidates for surgery, particularly neurosurgery or DBS implantation, due to significant cardiovascular, pulmonary, or other systemic comorbidities identified during preoperative evaluation.\n* Patients who have a history of taking the following in the three months prior to enrollment: Immunosuppressant, antipsychotic drug, anticonvulsant drugs or anticoagulant therapy (if discontinuation or perioperative adjustment is not feasible), botulinum toxin (within 6 months), phenol injections, or other treatments for dystonia or muscle spasm\n* History of Apomorphine use\n* History of chronic alcohol use or illicit drug abuse.\n* Patients who are pregnant, lactating, or people who did not avoid pregnancy during the study.\n* Patients who, according to the researchers' opinions, are not suitable for safe study.","30 Years",{"count":451,"type":24},6,[453],"PHASE1","Dopason is a phase I, open-label, multicenter, single-arm clinical trial designed to evaluate the safety and feasibility of intraputaminal transplantation of human embryonic stem cell-derived dopaminergic progenitor cells (DopaCells) in patients with moderately severe Parkinson's disease.",[28],[35,457,458],"Dopaminergic progenitor cell transplantation","Intrastriatal",{"date":460,"type":42},"2026-06-18",{"date":462,"type":42},"2025-08-01",{"date":464,"type":24},"2030-08-01",{"name":466,"class":467},"Royan Institute","OTHER_GOV",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":19,"minAge":391,"maxAge":21,"enrollmentInfo":476,"targetDuration":4,"studyType":62,"phases":478,"briefSummary":479,"conditions":480,"keywords":481,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":494},"100616937","phase-2-d-spark-a-clinical-trial-of-d-serine-for-modifying-parkinsons-disease-progression-100616937","NCT07312110","D-SPARK: A Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression","D-SPARK: A Randomized Double Blind Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression","D-SPARK","Inclusion Criteria:\n\n* A clinical diagnosis of PD\\* according to the clinically established MDS clinical diagnostic criteria for Parkinson's disease within 5 years.\n* \\[¹²³I\\]FP-CIT single photon emission CT (DaTscan) confirming dopaminergic nigrostriatal denervation.\n* Hoehn and Yahr score \\\u003C 3 at enrollment.\n* Optimal symptomatic PD treatment, not requiring adjustments, for at least 2 weeks.\n* Age ≥40 and ≤ 80 years at time of enrollment.\n\nExclusion Criteria:\n\n* Dementia or neurodegenerative disorder other than PD at baseline visit.\n* Atypical parkinsonism (PSP, MSA, CBD vascular parkinsonism, or drug induced parkinsonism).\n* Any known monogenic cause of PD (GBA1 variation is accepted).\n* Any psychiatric disorder that would interfere with compliance in the study.\n* Any severe somatic illness that would make the individual unable to comply and participate in the study.\n* Use of D-serine supplementation within 90 days of enrolment.\n* Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.\n* Active of planned pregnancy during trial period.\n* Cognitive impairment as measured by the Mini Mental Status Exam MMSE) \\\u003C 20.\n* Weight \\\u003C 45 kg.\n* Urinary albumin\u002Fcreatinine ratio ≥ 20 mg\u002Fmmol at time of enrollment.\n* Participants will be excluded if they have CKD stage 3 or higher, defined as:\n\n  * Estimated golumerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73min\\^2 at screening, calculated using the CKD-EPI 2021 creatinine equation.",{"count":477,"type":24},100,[221],"This clinical study, designed as a randomized, double-blind, placebo-controlled trial, aims to investigate if modulation of the N-methyl-D-aspartate receptor (NMDAR) via its co-agonist D-serine has therapeutic benefits in Parkinson's disease (PD). All patients will receive both placebo and D-serine over different time periods during the study.\n\nPreclinical studies have shown that blocking glycine transporters, which elevates endogenous glycine levels, can restore NMDAR function and improve motor deficits in PD models. A clinical trial demonstrated that oral D-serine (30 mg\u002Fkg\u002Fday for 6 weeks) significantly reduced extrapyramidal and abnormal involuntary movements in PD patients compared to placebo, with improvements observed in both motor and non-motor symptoms. D-serine supplementation has shown an acceptable safety profile with doses up to 120 mg\u002Fkg showing no significant adverse effects in clinical studies.\n\nThe D-SPARK trial primarily aims to determine the efficacy of D-serine supplementation on clinical severity of PD as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).\n\nSecondary aims are to determine the efficacy of D-serine supplementation on improving dopaminergic nigrostriatal innervation as measured by single-photon emission tomography (SPECT) based imaging of the dopamine transporter (DaT-scan) and cognition as measured by the California Verbal Learning Test version 2 (CLVT-II).\n\nThe study will include 100 persons with Parkinson's disease (PwPD) diagnosed no longer than 5 years before baseline. Participants will be randomly assigned to receive D-Serine 4000 mg daily or placebo for defined periods of time during a 58 week treatment period, followed by a 12 week washout period.\n\nParticipants will undergo:\n\n* Clinical evaluations, including clinical rating scales and questionnaires.\n* Cognitive assessments.\n* Bio sampling of whole blood and blood plasma.\n* Single-photon emission tomography (SPECT) imaging of dopamine transporter levels (DaT-scan)\n\nThe outcomes of this study could potentially demonstrate that D-serine reduces symptom severity in Parkinson's disease and\u002For has an impact on the clinical trajectory of Parkinson's disease, benefiting persons living with Parkinson's disease, their families and society as a whole.",[397,28],[482,483,484],"Serine","Parkinsons disease","D-serine","2026-06-03",{"date":487,"type":42},"2026-06-04",{"date":489,"type":42},"2026-01-20",{"date":491,"type":24},"2028-12",{"name":493,"class":49},"Haukeland University Hospital",11,{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":19,"minAge":88,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":62,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":521,"leadSponsor":522,"locationsCount":133},"100562426","behavioral-intervention-for-lifestyle-physical-activity-in-parkinsons-disease-100562426","NCT06603012","Behavioral Intervention for Lifestyle Physical Activity in Parkinson's Disease","LifePD","Inclusion Criteria:\n\n* confirmed diagnosis of PD\n* Internet and email access\n* willingness to complete the cognitive assessments and questionnaires, wear the accelerometer, and undergo randomization\n* insufficient physical activity (i.e., not meeting current physical activity guidelines) based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire\n* self-reported ability to ambulate without assistance\n* age of 50+ years\n* English as a primary language\n* asymptomatic (i.e., one or fewer affirmatives on the Physical Activity Readiness Questionnaire \\[PAR-Q\\]) or physician approval for undertaking exercise training for those with 2 or more affirmatives on the PAR-Q\n\nExclusion Criteria:\n\n* above inclusion criteria not met\n* moderate or high risk of contraindications for possible injury or death when undertaking strenuous or maximal exercise using the PAR-Q\n* severe cognitive impairment that might preclude compliance with the conditions based on a modified Telephone Interview for Cognitive Status (TICS-M) score of less than 18\n* normal cognitive impairment based on the Montreal Cognitive Assessment (MoCA) score of 26 or more for avoiding ceiling effects involving change in cognitive function",{"count":503,"type":24},50,[64],"The investigators propose a Stage-I randomized controlled trial (RCT) of a remotely-delivered, 16-week social-cognitive theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding increases in device-measured physical activity and improvements in cognitive function, symptoms, and quality of life (QOL), and social-cognitive theory (SCT) outcomes among physically inactive persons with Parkinson's disease (PD). Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant\\'s home\u002Fcommunity and supported by Zoom-based chats guided by SCT via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. The investigators hypothesize that the home-based exercise intervention will yield improvements in cognitive, symptomatic, and QOL outcomes.",[28],[69,508,509,510,511,512,513,514,515,516,430,517],"Parkinsonian disorders","Movement disorders","Basal ganglia diseases","Brain diseases","Nervous system diseases","Central nervous system diseases","Neurodegenerative diseases","Cognition","Walking","Physical Activity","2026-06-02",{"date":487,"type":42},{"date":437,"type":24},{"date":439,"type":24},{"name":523,"class":49},"University of Illinois at Chicago",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":19,"minAge":531,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":62,"phases":533,"briefSummary":535,"conditions":536,"keywords":537,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":133},"100638226","phase-4-pilot-deprescribing-of-antimuscarinic-overactive-bladder-medications-in-parkinson-disease-100638226","NCT07627529","Pilot Deprescribing of Antimuscarinic Overactive Bladder Medications in Parkinson Disease","Evaluating the Effect of Deprescribing Antimuscarinic Overactive Bladder Medications on Cognitive Function and Quality of Life of Individuals With Parkinson Disease: A Pharmacist-led Series of N-of-1 Trials","Inclusion Criteria:\n\n1. 60+ years old at time of enrollment\n2. Have a diagnosis of Parkinson disease (PD) made by a movement disorders specialist\n3. Life expectancy of at least six months\n4. Are on an antimuscarinic for overactive bladder (OAB) symptoms (without concurrent use of a beta-3 agonist) for at least 3 months\n5. Are able to provide informed consent\n6. Are able to complete online surveys\u002Fquestionnaires\n7. Are able to receive telephone calls and Zoom calls\u002Ftelehealth meeting\n\nExclusion Criteria:\n\n1. Have untreated or uncontrolled hypertension (blood pressure \\[BP\\] ≥180\u002F110 mmHg),\n2. Have active urinary tract infection (UTI) or chronic\u002Frecurrent UTI (≥2 UTIs in six months or ≥3 in one year)\n3. Have moderate or severe hepatic impairment (Child-Pugh Score Class B or C)\n4. Have severe renal impairment (Estimated Glomerular Filtration Rate \\[eGFR\\] \\\u003C30 mL\u002Fmin\u002F1.72 m2) or end-stage renal disease (on dialysis or renal replacement therapy)\n5. Have prior history of hypersensitivity or intolerance to mirabegron or vibegron\n6. Have existing cognitive impairment (Montreal Cognitive Assessment \\[MoCA\\] score \\\u003C22\u002F30) or psychiatric disorder that preclude informed consent\n7. Have any other condition that, in Principal Investigator (PI) and Co-PI's opinion, makes the individual unsuitable for study participation\n8. On non-oral form of OAB antimuscarinics, the oral solution formulation of oxybutynin chloride or the oral suspension formulation of solifenacin succinate (due to complicated tapering process)","60 Years",{"count":325,"type":24},[534],"PHASE4","This is an unblinded, non-randomized National Institute of Health (NIH) Stage I of Behavioral Intervention Development trial. The investigators will enroll 20 subjects with Parkinson disease (PD) for a series of 20 of N-of-1 trials. The investigators will use a single-arm crossover titration\u002Freversal design (\"ON\" \\[A\\] vs. \"OFF\" \\[B\\]) with up to 4 periods. All participants will follow the sequence ABAB. Each period will last up to 10 weeks, allowing for sufficient time for up-titration and onset of drug action, and down-titration and washout. Each participant will have the option to participate in less (2-3) or more (3-4) periods depending on whether additional information is needed to make an informed decision about continuing or discontinuing the overactive bladder (OAB) antimuscarinic at the end of the study. The intervention drug will be an OAB antimuscarinic, previously prescribed to the participants by their physician. The investigators will reduce the dose of each OAB antimuscarinic by 25-50% every 1-2 weeks during the \"OFF\" \\[B\\] period, with the goal to completely discontinue the medication.",[28],[69,538,539,540,541,542],"overactive bladder","antimuscarinic","deprescribing","cognitive function","quality of life","2026-05-31",{"date":487,"type":42},{"date":546,"type":24},"2026-06",{"date":548,"type":24},"2027-04",{"name":550,"class":551},"Corporal Michael J. Crescenz VA Medical Center","FED",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":19,"minAge":391,"maxAge":559,"enrollmentInfo":560,"targetDuration":4,"studyType":62,"phases":562,"briefSummary":563,"conditions":564,"keywords":565,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":574,"locationsCount":133},"100634196","effects-of-dual-task-training-on-upper-extremity-function-in-parkinsons-disease-100634196","NCT07536542","Effects of Dual-Task Training on Upper Extremity Function in Parkinson's Disease","Effects of Dual-Task Training on Upper Extremity Function and Muscle Thickness in Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease confirmed by a neurologist\n* Modified Hoehn and Yahr stage 2 to 3\n* No medication or dosage change within the last 6 months\n* Cognitive capacity sufficient to understand and follow instructions, defined as Montreal Cognitive Assessment score ≥21\n* Voluntary participation with written informed consent\n\nExclusion Criteria:\n\n* Atypical or secondary parkinsonism\n* Advanced orthopedic condition affecting the upper extremity\n* Surgery, trauma, or immobilization involving the upper extremity within the last 6 months\n* Wound or dermatological condition preventing upper extremity ultrasonographic evaluation\n* Severe visual or hearing loss\n* Severe depression, psychosis, or communication difficulty\n* Any additional health problem preventing regular participation in the study","65 Years",{"count":561,"type":24},38,[64],"The goal of this clinical trial is to investigate the effects of dual-task training on upper extremity function and muscle thickness in individuals with Parkinson's disease. The main questions it aims to answer are:\n\nDoes dual-task training improve upper extremity function in individuals with Parkinson's disease? Does dual-task training lead to changes in upper extremity muscle thickness measured by ultrasonography?\n\nResearchers will compare a dual-task training group with a control group receiving routine care to determine whether 8 weeks of dual-task training results in greater improvements in upper extremity outco\n\nParticipants will:\n\ncomplete baseline and post-intervention assessments of upper extremity function, muscle thickness, grip strength, and pinch strength be assigned to either a control group or a dual-task training group receive dual-task training 3 days per week for 8 weeks if assigned to the intervention group",[28],[403,566,567,568,569],"Dual-Task Training","Upper Extremity Function","Muscle Thickness","Ultrasonography",{"date":518,"type":42},{"date":572,"type":42},"2026-04-24",{"date":286,"type":24},{"name":575,"class":49},"Ankara University",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":19,"minAge":449,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":62,"phases":586,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":133},"100639450","developing-precision-microbiota-based-cocktail-modification-therapy-to-delay-the-progression-of-parkinsons-disease-pd---use-preclinical-human-trials-to-confirm-the-impact-of-the-optimal-probiotic-y7-tryptophan-and-branched-chain-amino-acid-cocktail-formula-on-early-stage-pd-patients-100639450","NCT07619560","Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease (PD) - Use Preclinical Human Trials to Confirm the Impact of the Optimal \"Probiotic Y7, Tryptophan and Branched-chain Amino Acid\" Cocktail Formula on Early Stage PD Patients","Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease - Use Preclinical Human Trials to Confirm the Impact of the Optimal \"Probiotic Y7, Tryptophan and Branched-chain Amino Acid\" Cocktail Formula on Early Stage Parkinson's Disease Patient","Inclusion Criteria:\n\nSubject Inclusion Criteria:\n\n1. Age between 30-85 years old.\n2. Diagnosed with early-stage Parkinson's disease (Hoehn and Yahr scale stage 1-3).\n3. Brain MRI confirms striatal degeneration in the basal ganglia region, with no history of stroke.\n4. Responds to Parkinson's disease-related medications (e.g., Levodopa).\n5. Free of any major or acute illnesses.\n6. Able to comply with the 12 weeks intervention and required assessments for the study.\n\nExclusion Criteria:\n\n1. Unable to complete interviews or has mobility issues.\n2. Presence of major or acute illness before or during the study.\n3. Co-existing intestinal co-infections, such as CDI, E. coli, Salmonella, Shigella, Campylobacter, plague, or cytomegalovirus.\n4. Allergic to the intervention product.\n5. Pregnant or breastfeeding women.","85 Years",{"count":585,"type":24},120,[64],"Preclinical human trials will be utilized to validate the research direction, followed by clinical trials to assess the impact of a cocktail formula product containing the optimal probiotic Y7 combined metabolites on motor, cognitive, and non-motor functions in early Parkinson's disease patients. The study aims to recruit 120 patients (stage 1-3) and employ a two-arm, randomized controlled trial (RCT) design, dividing subjects into intervention and control groups for a 12 weeks trial period. Commercial development will be contingent upon the clinical trial outcomes, evaluating whether the product offers clinical benefits such as delaying Parkinson's disease progression in motor, cognitive, and non-motor functions. Additionally, a personalized and precise prognosis prediction model for Parkinson's disease will be established. This model will gather comprehensive clinical data, including motor function assessments (functional tests, UPDRS), biochemical markers, questionnaire responses, and genotype data (TPM array), as well as metabolite and microbial data. Through integrated analysis of this biological information using machine learning techniques, a personalized and accurate prognosis prediction model for Parkinson's disease will be developed. This model will predict the disease status of PD patients 12 weeks later, accounting for factors such as cocktail therapy. The results will empower PD patients to understand their individual disease progression and treatment prognosis, enabling them to prepare accordingly. Moreover, this model will aid researchers in identifying patient profiles more likely to benefit from treatment, thereby enhancing the evaluation of the efficacy and applicability of cocktail therapy.",[28,31,589],"Probiotic",[591,592,593],"Parkinson's Disease","Probiotics","Gut microbiota","2026-05-24",{"date":518,"type":42},{"date":597,"type":42},"2025-05-20",{"date":599,"type":24},"2027-08-31",{"name":601,"class":49},"Taipei Medical University",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":19,"minAge":391,"maxAge":21,"enrollmentInfo":610,"targetDuration":4,"studyType":62,"phases":611,"briefSummary":612,"conditions":613,"keywords":614,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":133},"100640932","robot-assisted-gait-training-vs-nmes-in-parkinsons-disease-100640932","NCT07589296","Robot-Assisted Gait Training vs NMES in Parkinson's Disease","Comparative Effects of Robot-Assisted Gait Training and Quadriceps Neuromuscular Electrical Stimulation Added to Standard Exercise Rehabilitation on Balance, Gait, Disease Severity, and Quadriceps Muscle Adaptations in Patients With Parkinson Disease: A Prospective Randomized Assessor-Blinded Clinical Trial","ROBO-NMES-PD","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease according to established clinical criteria\n* Age between 40 and 80 years\n* Hoehn and Yahr stage II-III\n* Ability to walk independently with or without assistive devices\n* Stable medical treatment for at least 4 weeks prior to study enrollment\n* Ability to understand and follow instructions\n* Willingness to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Severe cognitive impairment or inability to follow instructions\n* Hoehn and Yahr stage IV-V Parkinson's disease\n* Severe musculoskeletal disorders affecting gait (e.g., advanced osteoarthritis, recent fracture)\n* History of lower extremity surgery within the last 6 months\n* Severe cardiovascular or respiratory disease limiting exercise participation\n* Presence of other neurological disorders affecting mobility (e.g., stroke, multiple sclerosis)\n* Contraindications to electrical stimulation (e.g., pacemaker, implanted electronic devices)\n* Skin lesions or infections at electrode placement sites\n* Participation in another structured rehabilitation program within the last 3 months",{"count":142,"type":24},[64],"This prospective, randomized, assessor-blinded clinical trial aims to compare the effects of robot-assisted gait training and quadriceps neuromuscular electrical stimulation (NMES) when added to a standard exercise rehabilitation program in patients with Parkinson disease.\n\nParticipants will be randomly assigned to two parallel groups. Both groups will receive a standard rehabilitation program, while one group will additionally undergo robot-assisted gait training and the other group will receive quadriceps NMES. The interventions will be administered five days per week for six weeks.\n\nClinical outcomes, including balance, functional mobility, gait performance, and disease severity, will be evaluated at baseline, post-treatment, and follow-up (week 14). In addition, ultrasound-based assessments of quadriceps muscle thickness and cross-sectional area will be performed to investigate muscle adaptations.\n\nThe results of this study are expected to provide comparative evidence regarding the effectiveness of these two rehabilitation approaches and contribute to optimizing rehabilitation strategies in Parkinson disease.",[28],[69,615,616,617,618,619,620,569],"Robot-assisted gait training","Neuromuscular electrical stimulation","Quadriceps muscle","Rehabilitation","Balance","Gait","2026-05-11",{"date":623,"type":42},"2026-05-15",{"date":625,"type":42},"2026-04-15",{"date":627,"type":24},"2027-06-15",{"name":629,"class":49},"Kanuni Sultan Suleyman Training and Research Hospital",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":636,"targetDuration":638,"studyType":25,"phases":4,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":644,"leadSponsor":646,"locationsCount":133},"100639559","a-multimodal-convergent-cohort-of-parkinsons-disease-at-fjmuuh-fjmuuh-pd-natural-history-study-100639559","NCT07588763","A Multimodal Convergent Cohort of Parkinson's Disease at FJMUUH (FJMUUH-PD): Natural History Study","Inclusion Criteria:\n\n* The diagnosis of Parkinson's disease (PD) will be made according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016) issued by the Parkinson's Disease and Movement Disorders Group of the Neurology Branch of the Chinese Medical Association, with confirmation by at least two neurologists. Eligible patients must meet all of the following criteria:\n\nDefinite diagnosis of parkinsonism; No absolute exclusion criteria for PD are present; At least 2 supportive criteria for PD are satisfied; No red flags suggestive of alternative diagnoses are present.\n\nExclusion Criteria:\n\n* Patients meeting any of the following conditions will be excluded from the study:\n\nInability to complete assessments using the Unified Parkinson Disease Rating Scale (UPDRS); Inability to complete assessments using the Mini-Mental State Examination (MMSE); History of recurrent stroke causing stepwise deterioration of parkinsonian symptoms; Diagnosis of secondary parkinsonism or Parkinson-plus syndromes; History of recurrent head trauma or confirmed encephalitis; Presence of severe organ dysfunction; Presence of severe endocrine diseases; Presence of hematological disorders; Presence of autoimmune diseases; Current diagnosis of malignant tumors.",{"count":637,"type":24},3000,"10 Years","Parkinson's disease (PD) is a common neurodegenerative disorder in middle-aged and elderly individuals, with a global incidence of 2.0% among adults aged 65 and over. Its pathogenesis remains unclear, and effective preventive and therapeutic approaches are lacking. PD severely impairs patients' physical and mental health and quality of life, while also imposing a substantial burden on families and society. This study will enroll patients with idiopathic PD diagnosed in the Department of Neurology, Fujian Medical University Union Hospital, from 2026 to 2036 to establish a research cohort. Using a non-interventional design, participants will undergo long-term follow-up through regular clinical visits, scale-based assessments, imaging examinations, and biological specimen testing. Corresponding data will be collected to build a research platform, aiming to clarify the pattern of disease progression and identify early diagnostic biomarkers. All testing methods are safe and reliable and will not pose additional risks to patients.\n\nThis study will be conducted in strict compliance with ethical requirements. Prior to enrollment, patients will be fully informed of the study details and will voluntarily provide written informed consent. To mitigate the risk of privacy disclosure, measures including coded management, data encryption, and access restriction will be implemented throughout the study to protect participants' privacy, safeguard their legitimate rights and interests, avoid additional financial burdens, and ensure the study is conducted in a standardized manner.\n\nI hereby pledge to protect the personal privacy of all study participants and respect their autonomy. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Ethical Review Measures for Life Sciences and Medical Research Involving Human Subjects.",[28],"2026-05-09",{"date":623,"type":42},{"date":128,"type":24},{"date":645,"type":24},"2035-12-31",{"name":647,"class":49},"Fujian Medical University Union Hospital",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":19,"minAge":88,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":62,"phases":656,"briefSummary":657,"conditions":658,"keywords":659,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":108},"100609952","changes-in-movement-fitness-and-quality-of-life-in-people-with-parkinsons-disease-after-different-exercise-programs-100609952","NCT07221266","Changes in Movement, Fitness, and Quality of Life in People With Parkinson's Disease After Different Exercise Programs","Changes in Motor Function, Quality of Life, Cardiorespiratory Fitness, and Physiological Markers in People With Parkinson's Disease Following Different Exercise Interventions.","Inclusion Criteria:\n\n1. Diagnosis of Parkinson's Disease\n2. Independent ambulation\n3. Hoehn and Yahr stage of 1-3\n4. 50 years of age or older\n5. Must speak English or Spanish\n\nExclusion Criteria:\n\n1. History of stroke\n2. History of heart attack\n3. Non-ambulatory\n4. Hoehn and Yahr of stage 4 or 5\n5. Osteoporosis\n6. Unmanaged Parkinson's medication",{"count":278,"type":24},[64],"Parkinson's disease (PD) is a progressive neurological condition that can affect movement, balance, endurance, and overall quality of life. Exercise is widely recognized as one of the most effective non-pharmacological treatments to help people with PD maintain function and independence. However, not all exercise programs produce the same results, and more research is needed to understand which types of exercise offer the greatest physical and physiological benefits.\n\nThis study is designed to examine how different types of structured exercise programs influence motor function, cardiorespiratory fitness, and markers of overall health in individuals with Parkinson's disease. The goal is to better understand how exercise can be used to improve movement, daily activities, and general well-being, as well as how it affects the body at a physiological level.\n\nParticipants will be adults diagnosed with idiopathic Parkinson's disease who are medically stable and able to safely participate in exercise. Before beginning the study, participants will complete screening procedures to ensure safety and eligibility. Eligible participants will then be assigned to one of several supervised exercise interventions conducted over a defined period. Each exercise program is designed to improve movement and function but differs in structure or training emphasis (for example, aerobic, functional, or task-specific activity).\n\nExercise sessions will take place under the supervision of licensed physical therapist. Each session will include warm-up, exercise, and cool-down components. Intensity will be monitored using heart rate and perceived exertion to ensure safety and appropriate challenge. Participants will attend sessions multiple times per week for 8 weeks.\n\nResearchers will collect information about movement abilities, balance, walking, endurance, and daily function using standardized physical therapy assessments such as gait tests, balance measures, and questionnaires related to quality of life at baseline, after 8-weeks of intervention and once more after a 4-week follow-up. In addition, blood samples will be collected to analyze physiological responses to exercise at the same 3 testing intervals. These samples will allow investigators to measure biomarkers related to cardiovascular health, nitric oxide availability, oxidative stress, and inflammation. These biological indicators can help identify how exercise affects underlying health mechanisms that may contribute to improved function in people with Parkinson's disease.\n\nAll data will be collected by trained research personnel who are experienced in working with individuals with Parkinson's disease. Participants will be monitored for safety at each session, and any adverse events will be documented and reviewed by the principal investigator and the Institutional Review Board (IRB).\n\nBy comparing changes across the different exercise programs, this study aims to determine which interventions have the most meaningful impact on mobility, endurance, and quality of life, as well as which ones produce measurable physiological benefits. Results from this research may help guide physical therapists, rehabilitation professionals, and people with Parkinson's disease in choosing the most effective exercise approaches for maintaining function and promoting overall health.\n\nUltimately, this project seeks to contribute to the growing evidence that targeted, engaging, and appropriately dosed exercise can play a key role in improving the lives of people living with Parkinson's disease. The findings may also help inform future clinical practice guidelines, community exercise programs, and long-term wellness strategies for individuals with movement disorders.",[28],[591,660,661,662,663,664,665,666,667,668,669,670,671,672,673],"Exercise intervention","Physical Therapy","Guided Cycling","Non-contact boxing","Aerobic Exercise","Quality of Life","Endothelial Function","Blood Biomarkers","Homocysteine","Vitamin B-12","Inflammation","Oxidative stress","Balance Training","Motor Function","2026-05-04",{"date":676,"type":42},"2026-05-08",{"date":678,"type":42},"2026-04-21",{"date":680,"type":24},"2027-06-30",{"name":682,"class":49},"University of Texas, El Paso"]