[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"deep-brain-stimulation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:deep-brain-stimulation":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,45,79,109,140,165,187,226,246,281,301,329,355,386,414,453,481,507,528,552,575,597,620,641,662],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100617942","quantifying-motor-network-dynamics-to-predict-and-enhance-outcomes-in-pediatric-dystonia-100617942",false,"NCT07325175","Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia","Inclusion Criteria:\n\n* For dystonia subjects:\n* Dx of dystonia (with and without DBS)\n* willingness and ability to complete study protocols.\n* For Typically Developing Controls:\n* normal developmental milestones\n* absence of any neuropsychiatric disorder\n* no significant medical condition.\n\nExclusion Criteria:\n\n* history of epilepsy\n* presence of implanted medical devices (except DBS in dystonia subjects)\n* lack of cognitive or physical ability to complete study protocol.",true,"ALL","6 Years","21 Years",{"count":21,"type":22},75,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this study is to understand the development and progression of childhood dystonia, a movement disorder, in children. The main questions it aims to answer are:\n\nHow does the activity of the neural network evolve in children with dystonia in the context of motor development? What are the effects of chronic and active stimulation on cortical and subcortical motor network function in children with deep brain stimulation (DBS)?\n\nParticipants will:\n\n* Undergo noninvasive electrophysiological measurements (EEG, EMG) to quantify neural network activity. They will be tested at rest and during a simple motor reaction task.\n* Children with DBS will be assessed in the on and off DBS state to assess effects of chronic and active changes in motor network function.",[28,29,30,31],"Dystonia","Pediatric","Deep Brain Stimulation","Motor Development","RECRUITING","2026-06-15",{"date":35,"type":36},"2026-06-16","ACTUAL",{"date":38,"type":36},"2024-01-01",{"date":40,"type":22},"2029-12-31",{"name":42,"class":43},"Children's Hospital Medical Center, Cincinnati","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100614837","phase-2-a-study-of-buntanetap-in-participants-with-pd-100614837","NCT07284784","A Study of Buntanetap in Participants With PD","An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson's Disease","Inclusion Criteria:\n\n1. Diagnosis of idiopathic PD according to MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015) and\n\n   a. Cohort 1: Participated in a prior PD clinical trial with buntanetap. i. A legally authorized representative is required for any participant whose MMSE \\\u003C21 at screening.\n\n   b. Cohort 2: Has been receiving DBS treatment in either 1) the subthalamic nucleus or 2) the globus pallidus internus for at least 12 months after a successful DBS surgery that achieved the goal.\n\n   i. Female or male adults aged 40 to 85 years. ii. H\\&Y stage 1-3 in ON state. iii. MMSE 21-30 at screening and baseline.\n2. Have a support person who will accompany the participant on study visits at designated times.\n3. Female participants of childbearing potential\\* must have a negative urine pregnancy test at screening, must be non-lactating, and must agree to use a highly effective method of contraception (i.e., a method resulting in a failure rate of less than 1% per year when used consistently and correctly) during the trial and for one month after the last dose of trial treatment, such as:\n\n   1. Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation,\n   2. Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation,\n   3. Intrauterine device (IUD),\n   4. Intrauterine hormone-releasing system (IUS),\n   5. Bilateral tubal occlusion,\n   6. Vasectomized partner (a vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the participant, and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used),\n   7. Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant).\n\n      * Non-childbearing potential includes surgically sterilized or postmenopausal with no menstrual bleeding for at least one year prior to study start.\n\n   Protocol ANVS-25002 Ver. 2.1; 09-23-2025 Confidential Page 30 of 54\n4. Male participants must be sterile or sexually inactive or agree not to father a child during the study and one month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male participants must adopt a highly effective method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as:\n\n   1. Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation,\n   2. Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation,\n   3. IUD,\n   4. IUS,\n   5. Bilateral tubal occlusion.\n5. No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the C-SSRS.\n6. Stability of permitted medications for at least 4 weeks prior to screening. Refer to Concomitant Medications section above for details on prohibited and permitted medications.\n\n   1. Standard of care anti-parkinsonian medication,\n   2. Cholinesterase inhibitors and\u002For memantine medication,\n   3. Anticonvulsant medications used for epilepsy or mood stabilization, or neuropathic pain indications, and have not had a breakthrough seizure 3 years prior to screening,\n   4. Mood-stabilizing psychotropic agents including, but not limited to, lithium,\n7. Adequate visual and hearing ability (physical ability to perform all the study assessments).\n8. Good general health with no disease expected to interfere with the study.\n\nExclusion Criteria:\n\n1. Cohort 1 only: Is currently receiving DBS treatment. (Participant may enroll in Cohort 2 if they meet the corresponding inclusion\u002Fexclusion criteria).\n2. A history of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), unless their symptoms have been mild, and they are stable on treatment or no longer need treatment. Mild depression or history of depression that is stable on treatment with selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) medication at a stable dose is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications.\n3. A history of seizure disorder. If stable on medication, it is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications.\n4. A history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 450 ms for men and ≥ 460 ms for women, or torsades de pointes.\n5. Bradycardia (\\\u003C50 bpm) or tachycardia (\\>100 bpm) on the ECG at screening and deemed medically significant by the PI.\n\n   Protocol ANVS-25002 Ver. 2.1; 09-23-2025 Confidential Page 31 of 54\n6. Uncontrolled Type-1 or Type-2 diabetes. A participant with hemoglobin subunit alpha 1c (HbA1c) levels up to 7.5% can be enrolled if the investigator believes the participant's diabetes is under control.\n7. Clinically significant renal (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] \\\u003C50 mL\u002Fmin\u002FBSA \\[body surface area\\]) or hepatic impairment (Alkaline phosphatase \\[ALP\\] \\> 2.0X the upper limit of normal \\[ULN\\] and\u002For total bilirubin \\> 2.0X ULN).\n8. Any clinically significant abnormal laboratory values. Participants with liver function tests (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\]) greater than twice ULN will be excluded.\n9. Is at imminent risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigators. Participants must be excluded if they report suicidal ideation with intent, with or without a plan or method (e.g., positive response to Items 4 or 5 in assessment of suicidal ideation on C-SSRS) in the past 2 months, or suicidal behavior in the past 6 months.\n10. Cancer or has had a malignant tumor within the past year, except participants who underwent potentially curative therapy with no evidence of recurrence (participants with stable untreated cancer are not excluded).\n11. Alcohol \u002F Substance use disorder, moderate to severe, in the last 5 years according to the most current version of the DSM.\n12. 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.\n13. A learning disability or developmental delay.\n14. Participants whom the site PI deems to be otherwise ineligible.\n15. A known allergy to the investigational drug or any of its components.\n\n    Inactive ingredients of the investigational medicinal product:\n    * Silicified microcrystalline cellulose\n    * Dibasic calcium phosphate dihydrate\n    * Mannitol\n    * Stearic acid\n    * Hypromellose (capsule shells structure)\n    * Titanium dioxide (opacifier of the capsule shells)\n16. Is currently pregnant, breast-feeding, and\u002For lactating.\n17. Uncontrolled hypertension (systolic \\>160mmHg and\u002For diastolic \\>95mmHg) or hypotension (systolic \\\u003C90mmHg and\u002For diastolic \\\u003C60 mmHg) and deemed medically significant by the PI.","40 Years","85 Years",{"count":55,"type":22},500,[57,58],"PHASE2","PHASE3","This study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study. This study will be conducted with two cohorts. Cohort 1 will enroll via invitation only for PD participants who have previously participated in buntanetap clinical trials. Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. Qualified participants will receive buntanetap 30mg QD after a screening period of up to 42 days.",[61,30],"Parkinson's Disease (PD)",[63,64,30,65,66,67,68],"Parkinson's Disease","PD","DBS","buntanetap","Open-Label","posiphen","2026-06-11",{"date":33,"type":36},{"date":72,"type":36},"2026-01-09",{"date":74,"type":22},"2029-11",{"name":76,"class":77},"Annovis Bio Inc.","INDUSTRY",27,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":44},"100444263","understanding-motivation-in-parkinsons-patients-through-neurophysiology-100444263","NCT05065151","Understanding Motivation in Parkinson's Patients Through Neurophysiology","MPPN","Inclusion Criteria:\n\n* Has Parkinson's Disease or Dystonia\n* Has Medtronic Percept or RC+S DBS device implanted in either GPI or STN\n* Has DBS device implanted either bilaterally or unilaterally\n* Male or female\n* More than 1 month post-DBS surgery\n\nExclusion Criteria:\n\n* Severe cognitive impairments\n* Has MOCA score below 20\n* Pregnancy\n* Age less than 18 years old","18 Years",{"count":88,"type":22},70,[25],"The study aims to better understand motivation and value-based decision-making in Parkinson's patients through neurophysiology using Medtronic's Percept DBS device. By combining behavioral tasks with neural recordings, the study seeks to uncover how DBS affects motivation, particularly in relation to effort, reward, and timing.",[92,30,93],"Parkinson Disease","Motivation",[95,96,97,65,30,63,92,64,98,99],"Parkinson's","Medtronic","Percept","Reward-based decision making","Task","2026-06-03",{"date":102,"type":36},"2026-06-05",{"date":104,"type":36},"2021-10-30",{"date":106,"type":22},"2030-12-01",{"name":108,"class":43},"University of California, San Francisco",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100461756","use-of-ceregate-therapy-for-freezing-of-gait-in-pd-100461756","NCT05292794","Use of CereGate Therapy for Freezing of Gait in PD","A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed With Parkinson's Disease","Inclusion Criteria:\n\n1. Participant has an implanted STN-DBS system with Boston Scientific Gevia™ or Genus™ R16 IPG connected to any brand lead or extension that have been approved by the FDA to be used with Gevia or Genus IPGs.\n2. Participant is receiving treatment with carbidopa\u002Flevodopa, and\u002For with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist.\n3. DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS\n\nExclusion Criteria:\n\n1. Participant is unable to understand the study requirements and the treatment procedures, or unwilling \u002F unable to provide written informed consent before any study-specific tests or procedures are performed.\n2. Participant is unwilling or unable to comply with visit schedule and study related procedures.\n3. Participant's medication regimen has not been stable for at least 28 days prior to CG initiation.\n4. Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation.\n5. Participant is less than 21 years of age or older than 80 years of age.\n6. Participant is a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception as determined by the study investigator.\n7. Participant has a terminal illness with life expectancy of \\\u003C 1 year.\n8. Participant has history of recurrent or unprovoked seizures.\n9. Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria.\n10. Participant is in a very advanced stage of Parkinson's disease defined as: (i) Stage 5 as classified by the Hoehn and Yahr scale on medication and DBS (non-ambulatory) or (ii) participant requires an assistive device to perform the TBC OFF-meds \u002FON-DBS at the time of enrollment.\n11. Participant has a condition that makes walking difficult or could interfere with the study procedures or confound the evaluation of the study data, including musculoskeletal issues, peripheral neuropathies, hip\u002Fknee prostheses, or any visual or anatomical abnormality that affects their walking.\n12. Participant has disabling dyskinesias.\n13. Participant has a history of suicide attempt or current active suicidal ideation as determined by a positive response to Items 2-5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (CSSRS).\n14. Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations).\n15. Participant has less than 8% arrhythmicity as measured in the Turning and Barrier Course Figures of 8 (TBC-F8) pre-CG therapy (ON Medications\u002FON DBS \u002FOFF CG).","80 Years",{"count":118,"type":22},41,[25],"A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.",[92,122,30],"Freezing of Gait",[92,63,122,124,125,126,127,128,129],"Freezing of Gait Symptoms in Parkinson Disease","Gait Disorders","Gait Disorders, Neurologic","Gait Disorder, Sensorimotor","Motor Disorder","Gait Impairment","2026-05-25",{"date":132,"type":36},"2026-05-28",{"date":134,"type":36},"2022-04-18",{"date":136,"type":22},"2027-07",{"name":138,"class":77},"CereGate Inc.",7,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":4},"100619088","phase-1-coordinated-reset-deep-brain-stimulation-for-parkinsons-disease-100619088","NCT07340073","Coordinated Reset Deep Brain Stimulation for Parkinson's Disease","CR DBS PD","Inclusion Criteria:\n\n* Diagnosis of Idiopathic Parkinson's Disease\n* Minimum age of 21 years old\n* Will be or has been implanted with the Boston Scientific Vercise Genus Rechargeable DBS system\n\nExclusion Criteria:\n\n* History of musculoskeletal disorders that affect movement of the limbs\u002Fgait\n* Other significant neurological disorder\n* Significant psychiatric disorder\n* History of dementia or cognitive impairment that precludes them from getting DBS surgery or per study staff judgment, MacCAT-CR assessment does not deduce that the participant has capacity to consent\n* Other significant medical disorder that could impede study participation\n* Pregnant women",{"count":148,"type":22},24,[150],"PHASE1","Deep brain stimulation (DBS) is a surgical implant procedure for the treatment of Parkinson's Disease (PD) utilizing medical devices approved by the FDA. A novel approach to current DBS approaches is called \"Coordinated Reset\" DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude and high frequency stimulation. This study will evaluate the safety and short-term efficacy of CR-DBS in PD. The results from this study will significantly advance the development of CR-DBS for the treatment of PD. Findings in this study will also provide the rationale for further development of this novel DBS approach for other neurological and psychiatric disorders.",[61,30],[154,63],"Deep Brain Simulation","NOT_YET_RECRUITING","2026-05-18",{"date":158,"type":36},"2026-05-20",{"date":160,"type":22},"2026-07-01",{"date":162,"type":22},"2031-07-01",{"name":164,"class":43},"University of Minnesota",{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":116,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":185,"locationsCount":44},"100624512","safety-and-tolerability-of-patterned-stimulation-for-dbs-in-the-home-setting-100624512","NCT07410598","Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting","Inclusion Criteria:\n\n* Bilateral STN or GPi DBS with Boston Scientific Vercise Genus DBS System\n* Diagnosis of Parkinson's disease as confirmed by a movement disorders fellowship trained neurologist\n* Chronic stable DBS therapy, defined as having DBS therapy for at least 6 months\n\nExclusion Criteria:\n\n* History of previous neurosurgical intervention aside from DBS\n* Diagnosis of dementia (whether primary or related to Parkinson's disease)\n* A diagnosis of atypical parkinsonism or secondary parkinsonism at any time after DBS implantation",{"count":172,"type":22},60,[25],"The primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.",[92,30],[177,64,65,178],"Parkinson disease","deep brain stimulation","2026-05-05",{"date":181,"type":36},"2026-05-06",{"date":181,"type":22},{"date":184,"type":22},"2028-03-01",{"name":186,"class":43},"University of Florida",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":44},"100471336","low-intensity-focused-ultrasound-for-mild-cognitive-impairment-and-mild-alzheimers-disease-100471336","NCT05417555","Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease","Modulation of Hippocampal Circuitry and Memory Function With Focused Ultrasound in Amnestic MCI","LIFUP-MCIAD","Inclusion Criteria\n\n* Amnestic MCI or Mild Alzheimer's diagnosis\n* Age 50-90\n* English-speaking\n* Ability to provide informed consent\n* Normal or corrected-to-normal hearing and vision\n\nExclusion Criteria\n\nGENERAL\n\n* Participation in another clinical trial\n* Active use of immunotherapeutic medications for cognition (Aduhelm, Leqembi, Kisunla)\n* Moderate to Severe Alzheimer's\n* Inability to provide informed consent\n\nMRI-Related:\n\n* Weight exceeding 275 pounds\n* Pregnancy, suspicion of pregnancy, or attempting to become pregnant\n* Claustrophobia\n* Difficulties during previous MRIs\n* Top permanent retainer (bottom only is okay), 5 or more non-removable gold-teeth, metal braces, top spacers, and\u002For palate expanders\n* Any of the following implants: Cardiac Pacemaker, Aneurysm clips, Cochlear implants, Defibrillator, Electrodes or wires, Magnetically-activated device, Spinal cord stimulator, Infusion or insulin pumps, Implanted drug infusion device, Deep brain stimulation device\n* Non-removable hairpieces, hairpiece extensions, and\u002For piercings\n* Facial tattoos or permanent makeup\n* Metal implants that are MR-incompatible, or where participant is unable to provide sufficient information to determine MR compatibility\n* Previous injury by metallic foreign body (e.g., bullet, BB, shrapnel) where the object entered the body and participant lacks doctor's confirmation that it was fully removed\n\nMedical:\n\n* Diagnosis of one or more of the following neurological disorders: Parkinson's disease, Lou Gehrig's disease (ALS), Multiple sclerosis, Cerebral Palsy\n* Diagnosis of one or more of the following genetic disorders: Cystic Fibrosis, Sickle Cell Disease\n* Diagnosis of one or more of the following psychiatric disorders: Bipolar, Psychosis\n* Psychiatric illness that has not been controlled for at least two months (if controlled \\>2 months, with or without medication, they are not exclusionary)\n* Severe lung, liver, heart, and\u002For kidney disease\u002Fs (e.g., heart failure, liver failure, and etc...)\n* Diagnosis of thyroid disorder or change of thyroid medication dose within the last 3 months\n* Cancer treatment\u002Fs with chemotherapy and\u002For radiation to head and neck, or stage 4 (metastatic) cancer\n* Autoimmune disorder or viral infection such as HIV, COVID 19, or hepatitis C that has caused current problems with cognition\u002Fmemory\n* History of substance abuse in the past year\n* History of stroke (Transient ischemic attack \u002F mini-stroke not exclusionary if symptoms lasted \\\u003C1 week)\n* History of 2 or more seizures or diagnosis of epilepsy, unless the seizures occurred prior to age 5 alongside a fever.\n* History of brain tumor, brain aneurysm, brain hemorrhage, or subdural hematoma (transient ischemic attack not exclusionary)\n* Head injury that resulted in loss of consciousness lasting \\>30 minutes, cognitive issues lasting \\>18 months, and\u002For brain abnormalities visible in CT or MRI scan\n* Uncontrolled high blood pressure or diabetes\n* Heart attack within the last year","50 Years","90 Years",{"count":198,"type":22},144,[25],"The goal of this study is to investigate whether Low Intensity Focused Ultrasound Pulsation (LIFUP) targeting a part of the brain involved in memory will have an affect on brain activity and whether it may improve memory in people with Mild Cognitive Impairment and Mild Alzheimer's Disease.\n\nThe main questions the study seeks to answer are:\n\n1. Can LIFUP increase brain activity in the targeted area?\n2. Can LIFUP improve memory in people with MCI and mild AD?\n3. Can LIFUP improve connectivity of memory networks in the brain?\n\nParticipants in this study will complete MRIs and memory testing, and receive Low Intensity Focused Ultrasound to a part of their brain involved in memory (the entorhinal cortex).",[202,203,30,204],"Mild Cognitive Impairment","Amnestic Mild Cognitive Disorder","Mild Alzheimer's Disease",[206,207,208,209,210,211,212,213,214,215,216],"deep brain stimulation (DBS)","transcranial focused ultrasound stimulation (tFUS)","memory","low-intensity focused ultrasound pulsation (LIFUP)","fMRI","mild cognitive impairment","mci","noninvasive brain stimulation (NIBS)","ultrasound","Alzheimer's Disease","Mild Alzheimer's","2026-04-13",{"date":219,"type":36},"2026-04-16",{"date":221,"type":36},"2022-09-01",{"date":223,"type":22},"2026-07-31",{"name":225,"class":43},"University of California, Los Angeles",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":44},"100482912","udall-project-1-aim-4-100482912","NCT05568199","Udall Project 1 Aim 4","Inclusion Criteria:\n\n* Implanted with a DBS system\n* Existing 7T imagery (either done as standard-of-care or done as part of Noam Harel's study, IRB #1210M22183)\n* Diagnosed with idiopathic Parkinson's Disease\n* Minimum age 21 years\n\nExclusion Criteria:\n\n* Other significant neurological disorder, as determined by PI\n* Diagnosis of dementia\n* Pregnant",{"count":233,"type":22},100,"OBSERVATIONAL","By defining the strength and direction of connectivity patterns at rest and during movement across the basal ganglia-thalamocortical (BGTC) network we will characterize the role of individual circuits in motor performance and cognitive function, paving the way for future development of optimization algorithms for DBS that take advantage of this understanding.",[237,30],"Parkinsons Disease","2026-04-02",{"date":240,"type":36},"2026-04-08",{"date":242,"type":36},"2024-03-05",{"date":244,"type":22},"2027-03-01",{"name":164,"class":43},{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":17,"minAge":254,"maxAge":86,"enrollmentInfo":255,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":256,"conditions":257,"keywords":265,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":44},"100561089","a-multicenter-pediatric-deep-brain-stimulation-registry-100561089","NCT06585618","A Multicenter Pediatric Deep Brain Stimulation Registry","Multicenter Pediatric Deep Brain Stimulation Registry","DBS-R","Inclusion Criteria:\n\n* Female or male patients between ages of 0-18 years.\n* Having received or scheduled to receive DBS for any neurological movement disorder.\n* Parents or legal guardians are able to provide written consent for prospective enrollment.","0 Years",{"count":233,"type":22},"There is limited data on outcomes for children who have undergone deep brain stimulation (DBS) for movement disorders, and individual centers performing this surgery often lack sufficient cases to power research studies adequately. This study aims to develop a multicenter pediatric DBS registry that allows multiple sites to share clinical pediatric DBS data. The primary goals are to enable large-scale, well-powered analyses of the safety and efficacy of DBS in the pediatric population and to further explore and refine DBS as a therapeutic option for children with dystonia and other hyperkinetic movement disorders. Given the current scarcity of evidence available to clinicians, this centralized multicenter repository of clinical data is critical for addressing key research questions and improving clinical practice for pediatric DBS.",[28,258,259,260,261,262,263,264,30],"Epilepsy in Children","Cerebral Palsy","Tourette Syndrome","Obsessive-Compulsive Disorder","Neurologic Disorder","Movement Disorders in Children","Movement Disorders",[30,65,266,267,268,269,270,271],"movement disorder","movement disorders in children","dystonia","chorea","dyskinesia","epilepsy","2026-03-16",{"date":274,"type":36},"2026-03-18",{"date":276,"type":36},"2024-07-30",{"date":278,"type":22},"2029-07-30",{"name":280,"class":43},"Boston Children's Hospital",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":44},"100513209","sleep-specific-dbs-therapy-in-parkinsons-disease-100513209","NCT05962489","Sleep-specific DBS Therapy in Parkinson's Disease","Inclusion criteria:\n\n* Diagnosis of idiopathic PD\n* At least 21 years old\n* Existing or planned 7T brain imaging\n* Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care\n* Surgery at UMN to implant bilateral DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care (or has already occurred, as long as the initial programming session is at least 2 weeks away)\n\nExclusion criteria:\n\n* Other significant neurological disorder\n* History of dementia\n* Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study\n* Pregnant women\n* Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip",{"count":288,"type":22},64,[25],"Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the U.S and worldwide. The brain mechanisms underlying these sleep disorders, and the effects of therapeutic interventions such as deep brain stimulation on sleep-related neuronal activity and sleep behavior, are not well understood. Results from this study will provide a better understanding of the brain circuitry involved in disordered sleep in PD and inform the development of targeted therapeutic interventions to treat sleep disorders in people with neurodegenerative disease.",[30,292,28],"Parkinson's Disease and Parkinsonism","2026-03-02",{"date":295,"type":36},"2026-03-03",{"date":297,"type":36},"2023-06-22",{"date":299,"type":22},"2027-08-01",{"name":164,"class":43},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":313,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":327,"locationsCount":4},"100626985","neural-mechanisms-of-aerobic-exercise-benefits-in-pd-with-dbs-100626985","NCT07442747","Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS","Neural Mechanisms Underlying the Benefits of Aerobic Exercise in Advanced Parkinson's Disease","Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's disease\n* Previous placement of bilateral Medtronic Percept DBS as standard of care treatment for PD\n* Clinically optimized DBS parameters for one month prior to enrollment\n* Ability to ambulate with or without an assistive device for 5 continuous minutes\n* Willingness to withhold antiparkinsonian medication and DBS stimulation for outcomes assessments\n\nExclusion Criteria:\n\n* Neurocognitive impairment that compromises the ability to provide informed consent\n* Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)\n* Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen:\n\n  1. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provided prior to participation.\n  2. Those who choose not to obtain physician clearance will not be eligible for participation. Those who do not receive physician clearance for high intensity exercise will not be eligible.\n* A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise\n* Current cardiac arrhythmia",{"count":309,"type":22},36,[25],"This study is focused on people with Parkinson's disease who already have deep brain stimulation devices. The goal is to understand how aerobic exercise, specifically forced vs voluntary cycling, affects movement, thinking, and brain activity in these individuals. Parkinson's disease is a progressive condition that impacts both movement and cognitive function. Previous research suggests aerobic exercise can improve PD symptoms, but the mechanisms underlying the improvement are not fully understood. This study aims to evaluate the neural (brain) mechanisms underlying exercise.",[63,30],[314,30,315,316,65,317,318,177,95,319,97,320,321],"Parkinson","Parkinson's disease","Deep Brain Stimulation Surgery","Exercise","exercise training","Parkinson's Disease with Deep Brain Stimulation","Cycling","Aerobic","2026-02-24",{"date":293,"type":36},{"date":325,"type":22},"2026-05-01",{"date":40,"type":22},{"name":328,"class":43},"The Cleveland Clinic",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":336,"enrollmentInfo":337,"targetDuration":339,"studyType":234,"phases":4,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":44},"100621873","predictors-of-clinical-outcomes-of-deep-brain-stimulation-in-parkinsons-disease-100621873","NCT07376278","Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease","A Prospective Observational Study for the Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease","Inclusion Criteria:\n\n1. Diagnosis of \"Clinically Established PD\" as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (MDS-PD criteria)\n2. Referred for DBS according to standard local clinical guidelines 2a. Significant motor complications despite optimized pharmacological treatment 2ai. UPDRS motor score \\>30\u002F108 in the off-medication state 2aii. Hoehn and Yahr staging \\>2.5\u002F5 in the off-medication state 2b. Dopamine responsive 2bi. \\>33% improvement in UPDRS motor score after levodopa administration 2c. Age ≤75 years 2d. No contraindication to surgery or other significant comorbidity with limited life expectancy 2e. No significant psychiatric problems or cognitive impairment 2f. No structural lesions or features suggestive of atypical parkinsonism or other mimickers of idiopathic PD on neuroimaging\n\nExclusion Criteria:\n\n1. Unwilling to undergo blood sampling for study purposes\n2. Evidence of Parkinsonism due to heavy metal exposure\n3. History of neurodevelopmental disorder, neurodegenerative disease other than PD, CNS infection, neuroinflammatory disease (e.g. multiple sclerosis, CNS lupus), malignancy within the last 10 years, cerebrovascular accident, HIV infection, systemic autoimmune disease, alcohol dependence or other substance use\n4. Unable to pass DBS pre-operative assessment or unwilling to undergo DBS","75 Years",{"count":338,"type":22},30,"5 Years","The goal of this observational study is to identify factors in blood that are associated with response to deep brain stimulation (DBS) surgery in patients with Parkinson's disease. The main questions it aims to answer are:\n\n1. What factors in blood (proteins and RNA) are associated with good vs poor response to DBS?\n2. Are these factors able to predict response to DBS?\n3. How do these factors change before and after DBS?\n\nBlood and leftover brain tissue (which spontaneously adhere to the surgical instruments) will be taken and routine clinical data (including scores from routine assessments) will be collected from consenting participants who undergo DBS.",[30,342],"PARKINSON DISEASE (Disorder)",[178,65,315,344,345,346],"multiomic","transcriptomic","proteomic","2026-02-23",{"date":322,"type":36},{"date":350,"type":36},"2026-02-05",{"date":352,"type":22},"2038-02-01",{"name":354,"class":43},"Hong Kong University of Science and Technology",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":16,"sex":17,"minAge":86,"maxAge":53,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":371,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":44},"100625026","lifus-for-neurological-disorders-100625026","NCT07417280","LIFUS For Neurological Disorders","Clinical Effects of Low-Intensity Focused Ultrasound Neuromodulation in Patients With Neurological and Psychiatric Disorders","Inclusion Criteria:\n\n* 18-85 years of age\n* Patients diagnosed with neurological disorders, (such as epilepsy, brain tumour, movement disorders) or psychiatric disorders (such as substance abuse disorder)\n* Patients undergoing medical or surgical treatment (such as DBS) for neurological disorders\n\nExclusion Criteria:\n\n* History of stroke\n* Comorbid dementia\n* Scored below 22 on the Montreal Cognitive Assessment (MoCA)\n* Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)\n* Presence of metal implanted in body that is contraindicated in TMS\u002FMRI\n* Pregnancy\n* Major depression\u002Fpsychiatric disorder that in the opinion of the Investigator will affect patient's understanding of study procedures and willingness to abide by all procedures during the course of the study\n* Receiving a psychotropic medication or taking recreational substances that in the opinion of the investigator will significantly affect safety of the protocol\n* Major systemic illness or infection",{"count":363,"type":22},50,[25],"Low intensity focused ultrasound (LIFUS) has the potential to be used as a means of non-invasive neuro-modulation. To this day, the use of LIFUS is under investigation. Studies in healthy subjects have shown that application of LIFUS to the motor region of the brain can mildly decrease neuron excitability in healthy controls. The purpose of the present study is to evaluate the effects of LIFUS on brain tissue excitability in patients with movement disorders in order to elucidate the therapeutic potential of LIFUS.",[61,367,368,28,369,370,30],"Essential Tremor","Orthostatic Tremor","Epilepsy","Substance Abuse Disorder",[63,367,368,28,369,370,30,65,372,373,64,374,375,376],"Substance Use Disorder","SUD","LIFUS","Low-Intensity Focused Ultrasound","Neuromodulation","2026-02-10",{"date":379,"type":36},"2026-02-18",{"date":381,"type":36},"2025-12-02",{"date":383,"type":22},"2040-12-31",{"name":385,"class":43},"University Health Network, Toronto",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":399,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":413},"100585951","adaptive-vs-continuous-subthalamic-nucleus-deep-brain-stimulation-in-parkinsons-disease-100585951","NCT06909045","Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease","Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease","CLOSE-PD","Inclusion Criteria:\n\n* Diagnosis of idiopathic PD based on the UK Brain Bank criteria (Hughes et al. 1992);\n* Age older than 18 years;\n* Previous implantation of Medtronic PerceptTM PC\u002FRC DBS electrodes bilateral targeting the STN;\n* Optimal contact point compatible with aDBS in at least one STN;\n* Reliable beta peak in at least one STN;\n* Able to provide informed consent and comply with the study protocol;\n* Understand the Dutch language.\n\nExclusion Criteria:\n\n* Legally incompetent adults;\n* Patients with ongoing participation in other clinical trials involving neurological interventions;\n* Inability to recognize the difference between the motor ON or OFF state;\n* Mild cognitive impairment or dementia;\n* Pregnancy.",{"count":395,"type":22},130,[25],"The objective of the CLOSE-PD study is to compare the efficacy of adaptive deep brain stimulation (aDBS) with continue deep brain stimulation (cDBS) in patients with Parkinson's disease. The main question it aims to answer is:\n\n\\- whether the change in daily mean ON time without troublesome dyskinesia in aDBS is greater than cDBS over a six-month follow-up period?\n\nResearchers will compare aDBS to regular continue deep brain stimulation (cDBS).\n\nParticipants will:\n\n* be set up to cDBS during the first programming visit (visit 2);\n* be randomized 1:1 to aDBS or cDBS two weeks after visit 2;\n* follow-up will be at three and six months after visit 2;\n* complete PD Home diary at baseline, two weeks, three months and at six months after visit 2.",[30,92],[400,401,402,403],"adaptive DBS","continue DBS","aDBS","cDBS","2026-01-28",{"date":406,"type":36},"2026-01-29",{"date":408,"type":36},"2026-01-27",{"date":410,"type":22},"2027-02-01",{"name":412,"class":43},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",4,{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":17,"minAge":421,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":430,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":44},"100621337","comparing-biomarker-guided-dbs-programming-with-standard-clinical-monopolar-programming-100621337","NCT07369310","Comparing Biomarker-Guided DBS Programming With Standard Clinical Monopolar Programming","Randomized Trial on DBS Programming Based on Biomarkers vs. Standard Monopolar Review","Inclusion Criteria:\n\n* Age between 30 and 70 years.\n* Confirmed diagnosis of idiopathic Parkinson's disease according to the MDS diagnostic criteria (Postuma et al., 2015).\n* Indication for deep brain stimulation surgery based on CAPSIT-PD criteria.\n\nExclusion Criteria:\n\n* Presence of severe surgical complications (e.g., intracranial hemorrhage, infection).\n* Postoperative adverse events requiring electrode repositioning.\n* Any other medical or neurological condition that could interfere with safe participation in the trial.","30 Years","70 Years",{"count":424,"type":22},20,[25],"The goal of this clinical trial is to learn whether an objective, data-guided approach to programming deep brain stimulation (DBS) can improve motor outcomes in people with Parkinson's disease who undergo DBS surgery. The study includes adults aged 30 to 70 years with Parkinson's disease who are candidates for DBS.\n\nThe main questions it aims to answer are:\n\nDoes DBS programming based on objective markers (brain imaging and brain signals) reduce the amount of daily time patients spend in the OFF state more than conventional clinical programming?\n\nDoes this programming approach improve quality of life and motor symptoms compared with standard programming?\n\nResearchers will compare conventional DBS programming based on clinical monopolar review with DBS programming guided by electrode location on neuroimaging and beta brain signals recorded from the implanted device, to see if the objective approach leads to better motor control and less OFF time.\n\nParticipants will:\n\nUndergo DBS surgery using a clinically approved DBS system\n\nBe randomly assigned to one of two DBS programming strategies\n\nWear inertial sensors at home for several days at different time points to objectively measure motor symptoms\n\nAttend scheduled clinical visits for DBS programming and motor and non-motor assessments\n\nHave adaptive DBS activated after 3 months and continue follow-up until 6 months after programming begins",[63,314,428,429,65,30],"Parkinsons Disease (PD)","Motor Fluctuations",[63,30,431,432,433,434,435,436,437,438,439,440,441,429,442,443,376,444],"DBS Programming","Monopolar Review","Local Field Potentials","Beta Oscillations","BrainSense","Medtronic Percept","Neuroimaging-Guided Programming","Objective Programming","Adaptive Deep Brain Stimulatoin","Wearable Sensors","Inertial Sensors","OFF Time","Dyskinesia","Subthalamic Nucleus","2026-01-26",{"date":408,"type":36},{"date":448,"type":22},"2026-03-01",{"date":450,"type":22},"2028-09-01",{"name":452,"class":43},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":466,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":44},"100606510","revision-of-deep-brain-stimulator-in-patients-with-parkinsons-disease-100606510","NCT07176494","Revision of Deep Brain Stimulator in Patients With Parkinson's Disease","Revision of Deep Brain Stimulator in Patients With Parkinson's Disease: A Comparison of Perioperative Characteristics of Regional and General Anesthesia","Inclusion Criteria:\n\n* Those aged 40-85\n* Those with an ASA score of I-II-III\n* Those with a body mass index (BMI) between 18-30\n\nExclusion Criteria:\n\n* Those under 40 and over 85\n* Those with an ASA score of IV or higher\n* Those with a BMI of under 18 and over 30",{"count":363,"type":22},[25],"Parkinson's disease is a chronic and progressive neurodegenerative disease that affects the central nervous system, particularly impairing movement control. It is associated with the loss of dopamine-producing cells in the brain and typically occurs in middle age and beyond. Deep brain stimulation (DBS) is considered when symptoms of Parkinson's disease, such as tremors, slowed movements, and muscle rigidity, are not adequately controlled with medications. Selected patients with severe symptoms that do not respond to medical treatment are generally considered for this treatment.\n\nBattery revision surgeries can be performed under general anesthesia or regional anesthesia. Patients undergoing general anesthesia should be cautious about the potential complications of general anesthesia, while those undergoing regional anesthesia should be cautious about the local anesthetic systemic toxicity. Because each method has its own advantages, the choice of anesthesia may vary.\n\nThis study aimed to compare postoperative analgesic efficacy and patient satisfaction in patients who underwent surgery under general anesthesia or sedation-assisted battery replacement under regional anesthesia. Both anesthesia methods are routinely used in Parkinson's disease patients undergoing battery replacement.",[464,465,30,237],"Pain Management","Regional Anesthesia",[467,468,469,470],"Pectoserratus block","Interpektoral block","Deep brain stimulation","Awake surgery","2025-12-03",{"date":473,"type":36},"2025-12-10",{"date":475,"type":36},"2025-09-20",{"date":477,"type":22},"2026-07-20",{"name":479,"class":480},"Ankara Etlik City Hospital","OTHER_GOV",{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":488,"maxAge":489,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":44},"100607375","effect-of-mediterranean-diet-on-nutrition-in-parkinsons-disease-patients-with-bilateral-subthalamic-deep-brain-stimulation-100607375","NCT07187739","Effect of Mediterranean Diet on Nutrition in Parkinson's Disease Patients With Bilateral Subthalamic Deep Brain Stimulation","Investigation of the Effect of the Mediterranean Diet on Nutritional Status in Parkinson's Patients Undergoing Bilateral Subthalamic Nucleus Deep Brain Stimulation","Inclusion Criteria:\n\n* Being between 45-64 years of age\n* Signing informed consent\n* Undergoing STN DBS surgery\n* Continuing antiparkinsonian therapy\n* Those with a Mini Mental Test result of ≥24 points\n\nExclusion Criteria:\n\n* Having any psychiatric illness\n* Those with a Mini Mental Test result of \\\u003C24 points\n* Those with a disease requiring a special diet other than Parkinson's Disease","45 Years","64 Years",{"count":148,"type":22},[25],"The goal of this clinical trial is to evaluate whether Mediterranean diet can help manage body weight and improve body composition in adult Parkinson's disease patients who have undergone bilateral subthalamic nucleus deep brain stimulation (STN DBS).\n\nThe main questions it aims to answer are:\n\nDoes adherence to the Mediterranean diet for three months post-surgery help control body weight gain in STN DBS patients?\n\nDoes the Mediterranean diet positively affect body composition and other clinical parameters such as nutritional status, appetite, quality of life, and physical activity?\n\nResearchers will compare an intervention group following the Mediterranean diet with a control group continuing their usual diet to see if dietary guidance leads to improvements in weight management, body composition, and other nutritional status parameters.\n\nParticipants will:\n\nBe randomized into intervention and control groups.\n\nReceive Mediterranean dietary recommendations (intervention group) or continue usual diet (control group).\n\nUndergo evaluations at baseline (pre-operative), and at the 1st, 2nd, and 3rd months post-operatively using the following tools:\n\nVisual Appetite Scale\n\nHoehn and Yahr Questionnaire\n\nParkinson's Disease Quality of Life Questionnaire-8\n\nMovement Disorder Society-Unified Parkinson's Disease Rating Scale - Part 2\n\nMediterranean Diet Adherence Scale\n\nFood Consumption Record\n\nHave their anthropometric measurements and body composition (e.g., weight, waist and neck circumference, upper arm circumference, handgrip strength) assessed.",[92,30,316],[495,496,497,498,92],"Mediterranean Diet","Body Weight","Body Composition","Dietary Assesment","2025-11-26",{"date":471,"type":36},{"date":502,"type":36},"2025-09-25",{"date":504,"type":22},"2026-03",{"name":506,"class":43},"Ankara University",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":514,"briefSummary":516,"conditions":517,"keywords":519,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":44},"100477189","early-phase-1-optimization-of-deep-brain-stimulation-parameters-in-patients-with-medically-refractory-epilepsy-100477189","NCT05493722","Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy","Inclusion Criteria:\n\n* medically refractory epilepsy\n* already have a deep brain stimulator in place\n\nExclusion Criteria:\n\n* severe dementia at investigator discretion",{"count":424,"type":22},[515],"EARLY_PHASE1","Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures.",[518,30],"Refractory Epilepsy",[518,178],"2025-10-22",{"date":522,"type":36},"2025-10-24",{"date":524,"type":36},"2023-09-15",{"date":526,"type":22},"2030-01-15",{"name":164,"class":43},{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":16,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":44},"100589875","cognitive-decline-following-deep-brain-stimulation-a-dbs-fmri-study-100589875","NCT06960096","Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study","A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study","Inclusion Criteria:\n\n* Subjects above 18 years of age\n* Individuals with a PD diagnosis as defined by the UK Brain Bank diagnostic criteria for Parkinson's disease (58) which have undergone a neurological and neuropsychological evaluation at MUSCs movement disorder center, and were selected to undergo 3T compatible unilateral or bilateral STN- DBS implants\n\nExclusion Criteria:\n\n* Uncorrected visual or hearing impairments, as indicated by self-report\n* Individuals who are pregnant or expect to become pregnant during the course of the study\n* Individuals that have a history of neurological disease (other than PD) including previous stroke, major head trauma, and epilepsy or seizures.\n* Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner\n* COPD with oxygen dependence\n* Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)",{"count":536,"type":22},55,"The objective of this research study is to understand how Deep Brain Stimulation (DBS) targeting the subthalamic nucleus (STN) affects cognitive networks in the brain, potentially leading to cognitive decline in patients with Parkinson's Disease (PD). A total of 55 participants with PD who have undergone DBS surgery will be recruited from MUSC's Clinical DBS Program. Participants will attend two post-DBS visits: a 3-hour visit for consent, demographic, and cognitive assessments, and a 3-hour DBS-MRI visit to evaluate brain network connectivity with stimulation ON and OFF. These findings will help improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.",[30,92],[540,541,178,542],"Brain","Parkinsons","Cognitive","2025-10-10",{"date":545,"type":36},"2025-10-14",{"date":547,"type":36},"2025-08-21",{"date":549,"type":22},"2028-04-01",{"name":551,"class":43},"Medical University of South Carolina",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":16,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":561,"conditions":562,"keywords":563,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":4},"100606292","consensus-statements-on-deep-brain-stimulation-in-patients-with-parkinsons-disease-100606292","NCT07173660","Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease","Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease - A Delphi Study","DBS_Consensus","Panelist selection\n\nHealthcare professionals will be recruited as panelists based on the following predefined criteria:\n\nInclusion criteria:\n\n* At least 5 years of clinical experience in the care of patients with Parkinson's disease, including involvement in deep brain stimulation (DBS) implantation (in both teaching and non-teaching settings).\n* Prior participation in guideline development or authorship of at least one peer-reviewed publication on neuromodulation in Parkinson's disease.\n\nExclusion criteria:\n\n\\- None.\n\nRecruitment strategy:\n\n\\- Purposive sampling will be applied to identify Italian panelists, primarily through a review of recent publications in the field of DBS for Parkinson's disease. Panelist selection will adhere to the predefined criteria, with deliberate efforts to ensure gender balance and broad geographical representation across Italy.",{"count":338,"type":22},"Deep brain stimulation (DBS) has become a cornerstone therapy for advanced Parkinson's disease (PD), showing superior outcomes over best medical treatment in randomized clinical trials. By delivering adjustable electrical stimulation to key basal ganglia targets, DBS improves tremor, rigidity, bradykinesia, and motor fluctuations, while also reducing dopaminergic medication requirements. Its success, however, depends not only on precise surgical targeting but also on careful patient selection, multidisciplinary planning, and structured long-term follow-up.\n\nIn Italy, PD affects nearly 176,000 individuals, of whom an estimated 2-4.5% are potential candidates for DBS. A national survey conducted by the Italian Neurosurgery Society (SINch) revealed marked heterogeneity in surgical approaches, target selection, and team composition across DBS centers-reflecting similar international variability. Yet, clear national indications and guidelines have not been established. To address this gap, we conducted an expert consensus using the Delphi methodology.",[30,92],[564,565],"Expert Consensus","Neurosurgery","2025-09-17",{"date":568,"type":36},"2025-09-23",{"date":570,"type":22},"2025-09-15",{"date":572,"type":22},"2026-04-01",{"name":574,"class":43},"University Magna Graecia",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":17,"minAge":581,"maxAge":53,"enrollmentInfo":582,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":583,"conditions":584,"keywords":586,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":44},"100601814","eeg-measurements-to-capture-dbs-induced-electric-potentials-100601814","NCT07115394","EEG Measurements to Capture DBS-induced Electric Potentials","Inclusion Criteria:\n\n* Provision of written informed consent by the patient\n* Age 35 - 85\n* patient groups: Parkinson's disease, essential tremor, dystonia\n* \\>3 months after surgery for DBS\n\nExclusion Criteria:\n\nnone.","35 Years",{"count":424,"type":22},"To measure the electric fields induced by DBS (deep brain stimulation) on the scalp and to improve electric field simulations, the investigators will measure EEG (electroencephalography) measurements with high sampling rates (\\>100 kHz). The investigators hypothesize that we can improve electric field simulations of DBS by validating and calibrating the simulations based on EEG measurements at high sampling rates (\\>100 kHz).",[30,585],"Parkinson's Disease",[178,587,588],"EEG","electric potential","2025-08-17",{"date":547,"type":36},{"date":592,"type":36},"2025-07-11",{"date":594,"type":22},"2026-12-31",{"name":596,"class":43},"Universitätsklinikum Hamburg-Eppendorf",{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":23,"phases":606,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":44},"100589245","phase-4-imaging-biomarkers-of-fog-response-to-dbs-100589245","NCT06951906","Imaging Biomarkers of FOG Response to DBS","Imaging Biomarkers of Freezing of Gait Response to Deep Brain Stimulation","Inclusion Criteria:\n\n1. \\>40 years of age.\n2. diagnosis of PD based on UK Brain Bank diagnostic criteria.\n3. presence of FOG, defined as a score of 1 on part 1 of the nFOGQ and confirmed by objective evaluation (a score of 1 represents a positive response of having experienced such an episode over the last month).\n4. clinically selected at the MUSC DBS Conference to undergo STN-DBS surgery.\n\nExclusion Criteria:\n\n1. a history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities).\n2. inability to complete gait assessments (timed-up-and-go task) in the OFF state without assistance or assist devices.\n3. contraindications to MRI, including inability to lie supine in the scanner environment, pregnancy, and non-MRI compatible metal implants.\n4. implantation of non-3 T MRI-compatible DBS devices.",{"count":605,"type":22},54,[607],"PHASE4","For this study, the investigators are recruiting 54 individuals with Parkinson's Disease and Freezing of Gait (FOG) who are planning to undergo Deep Brain Stimulation (DBS). The objective of this study is to better understand the FOG response to DBS. Prior to DBS, participants will undergo an MRI scan, behavioral assessment related to walking, a cognitive evaluation, and assessment of other Parkinson's disease symptoms. Following DBS, participants will repeat these assessments at multiple timepoints over the period of one year. Overall, participants will complete a total of 7 visits over a period of approximately 1 year.",[610,30],"Freezing of Gait Symptoms in Parkinson's Disease",[122,63,30],"2025-08-01",{"date":614,"type":36},"2025-08-06",{"date":616,"type":36},"2024-11-11",{"date":618,"type":22},"2030-01",{"name":551,"class":43},{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":44},"100504038","the-stereo-dbs-study-7-tesla-mri-brain-network-analysis-for-deep-brain-stimulation-100504038","NCT05843084","The STEREO-DBS Study: 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation","STEREO-DBS","1.2 Inclusion criteria\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Age \\> 18 years;\n* Idiopathic PD who underwent STN DBS\n\n1.3 Exclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Legally incompetent adults;\n* No written informed consent.",{"count":55,"type":22},"Rationale: Deep brain stimulation (DBS) of the nucleus subthalamicus (STN) is an effective surgical treatment for the patients with advanced Parkinson's disease, despite optimal pharmacological treatment. However, individual improvement after DBS remains variable and 50% of patients show insufficient benefit. To date, DBS-electrode placement and settings in the highly connected STN are based on 1,5-Tesla or 3-Tesla MR-images. These low resolution and solely structural modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections. By using structural 7-Tesla MRI (7T MRI) connectivity to visualize (malfunctioning) brain networks, DBS-electrode placement and activation can be individualized.\n\nObjective: Primary objective of the study is to determine whether visualisation of cortical projections originating in the STN and the position of the DBS electrode relative to these projections using 7T MRI improves motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III).\n\nSecondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden.\n\nStudy design: The study will be a single center prospective observational study.\n\nStudy population: Enrollment will be ongoing from April 2022. Intervention (if applicable): No intervention will be applied. Application of 7T MRI for DBS is standard care and outcome scores used will be readily accessible from the already existing advanced electronic DBS database.\n\nMain study parameters\u002Fendpoints: The primary outcome measure is the change in motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III). This is measured after 6 months of DBS as part of standard care. The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Parkinson's Disease Questionnaire 39, Starkstein apathy scale, patient satisfaction with the treatment, patient evaluation of treatment burden, operating time, hospitalization time, change of tremor medication, side effects and complications.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The proposed observational research project involves treatment options that are standard care in daily practice. The therapies will not be combined with other research products. Participation in this study constitutes negligible risk according to NFU criteria for human research.",[92,630,540,444,30,631,632],"Diffusion Magnetic Resonance Imaging","Human","Treatment Outcome","2025-07-22",{"date":635,"type":36},"2025-07-25",{"date":637,"type":36},"2022-04-11",{"date":639,"type":22},"2033-04-11",{"name":412,"class":43},{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":116,"enrollmentInfo":648,"targetDuration":4,"studyType":23,"phases":649,"briefSummary":650,"conditions":651,"keywords":652,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":660,"locationsCount":44},"100594674","impact-of-frequency-specific-subthalamic-nucleus-subregion-stimulation-on-inhibitory-control-in-parkinsons-disease-100594674","NCT07022522","Impact of Frequency-specific Subthalamic Nucleus Subregion Stimulation on Inhibitory Control in Parkinson's Disease","Frequency-dependent Modulation of Inhibitory Control Via Subthalamic Nucleus Subregional Stimulation in Parkinson's Disease","Inclusion Criteria:\n\n1. Age 40-80 years old;\n2. Diagnosed with idiopathic Parkinson's disease;\n3. Meeting the indications for DBS surgery.\n\nExclusion Criteria:\n\n1. Patient declined to participate in the study;\n2. Presence of significant post-DBS complications (e.g., intracranial hemorrhage, cerebral edema, electrode misplacement);\n3. Significant psychiatric disorders or dementia (MMSE score \\\u003C20 for uneducated; \\\u003C23 for 1-6 years education; \\\u003C27 for ≥7 years education);\n4. Visual or auditory impairment affecting cognitive task performance\n5. History of conditions potentially impairing cognitive function.",{"count":424,"type":22},[25],"The core symptoms of Parkinson's disease (PD) include both motor and non-motor symptoms. Cognitive impairment is one of the most common non-motor symptoms in PD patients, with approximately 30% of patients exhibiting cognitive dysfunction at diagnosis and up to 80% eventually progressing to dementia. Among these, impairment of inhibitory control is the most detrimental cognitive dysfunction, as patients with compromised inhibitory control have difficulty suppressing impulsive behaviors and maintaining attention, which severely reduces their quality of life.\n\nThe subthalamic nucleus (STN) plays an important role in the development and progression of PD. Along its longitudinal axis from posterior to anterior, it can be divided into three subregions: motor, associative, and limbic. The motor subregion receives extensive projections from the motor cortex and serves as a core node in the PD motor network, participating in the coordination and control of motor function. The associative subregion receives widespread projections from the prefrontal cortex and serves as a core node in the cognitive control network, regulating cognitive processes such as inhibitory control, set-shifting, and working memory.\n\nHigh-frequency (\\>100Hz) deep brain stimulation of the STN (STN-DBS) is a well-established effective treatment for mid-to-late stage PD and can significantly improve motor symptoms. However, long-term high-frequency stimulation may exacerbate cognitive impairment. Recent studies have shown that low-frequency (4-10Hz) STN-DBS can improve cognitive functions such as working memory and verbal fluency in PD patients, but research on its effects in the domain of inhibitory control is lacking. Moreover, different STN subregions are involved in regulating distinct functions, yet previous studies have not differentiated the effects of stimulation targeting specific STN subregions.\n\nTherefore, conducting in-depth research on the effects of different stimulation frequencies applied to distinct STN subregions on inhibitory control function in PD patients is of great significance for exploring ways to improve cognitive impairment in PD and enhance the clinical individualized therapeutic effects of STN-DBS. This study plans to perform high- and low-frequency electrical stimulation of different STN subregions in PD patients who have undergone routine bilateral STN-DBS surgery, collect behavioral indicators during inhibitory control tasks (Arrow Flanker and Stop-Signal) under different stimulation conditions, and through comparative analysis, identify the specific stimulation sites and frequencies that can effectively improve inhibitory control function in PD patients.",[92,30],[30,653,444],"Cognition","2025-06-07",{"date":656,"type":36},"2025-06-15",{"date":658,"type":36},"2024-10-01",{"date":594,"type":22},{"name":661,"class":43},"Beijing Tiantan Hospital",{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":4,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":336,"enrollmentInfo":669,"targetDuration":4,"studyType":23,"phases":671,"briefSummary":672,"conditions":673,"keywords":675,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":44},"100592277","vcvs-for-apathy-in-pd-100592277","NCT06991335","VC\u002FVS for Apathy in PD","Deep Brain Stimulation (DBS) of the Ventral Capsule Ventral Striatum (VC\u002FVS) for the Treatment of Apathy in Parkinson's Disease (PD)","Inclusion Criteria:\n\n* Diagnosis of Parkinson's Disorder as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (MDS-PD).\n* Presence of severe apathy as determined by apathy criteria established by the International Society for Central Nervous System Clinical Trials and Methodology Apathy Working Group (ISCTM-AWG).\n* Apathy severity of -9 to +36, on the Lille Apathy Rating Scale (LARS) for at least 2 years.\n* Documentation by primary neurologist of refractoriness to treatment for apathy with at least two dopamine-based treatments (e.g., levodopa, dopamine agonist) of sufficient dose and duration.\n* Pre-DBS neuropsychological testing indicating normal cognition. Participants with mild cognitive impairment who have been evaluated by a cognitive neurologist for consideration of treatment (i.e., cholinesterase inhibitor) if indicated, may be included in the study once treatment has been stabilized for at least 2 months.\n* Ability and willingness to give informed consent.\n* Presence of a caregiver\u002Finformant who can complete study surveys\u002Finterviews related to the study participant.\n* Stability of antidepressant medication dosing (i.e., SSRIs, Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), etc.) for a minimum of four weeks prior to surgery.\n\nExclusion Criteria:\n\n* Major neurocognitive disorder (i.e., dementia) as determined by pre-DBS neuropsychological testing.\n* Explanation of apathy symptoms by comorbid depression as determined by a psychiatric interview including the Montgomery and Asberg depression rating scale (MADRS). Individuals with a MADRS score ≥15 will be excluded.\n* History of suicide attempt in the past 36 months or current active suicidal ideation (Yes to #2-5 on the Columbia Suicide Severity Rating Scale - C-SSRS).\n* Current PD-related psychosis (e.g., visual hallucinations).\n* Any psychiatric, neurological and\u002For medical condition that makes the subject, in the opinion of the investigators, a poor candidate.\n* Alcohol\u002Fsubstance use disorder, moderate or severe, within the previous 12 months.\n* Female who is pregnant or breastfeeding or has plans to become pregnant in the next 24 months.\n* Any contraindication for MRI.\n* Presence of any of the following disorders: a) central nervous system infection, b) toxic-metabolic encephalopathy, defined as a syndrome of delirium associated with an identifiable toxin such as a chemical or metabolic disorder, c) multiple sclerosis, d) developmental delay.\n* Need for diathermy.",{"count":670,"type":22},5,[25],"Apathy is a disabling neuropsychiatric symptom marked by reduced goal-directed behavior, including diminished interest, motivation, emotional expression, and social engagement. Though not formally defined in the DSM-V, apathy is common in several neurological and psychiatric disorders and significantly affects quality of life. In Parkinson's Disease (PD), it affects about 40% of patients and is associated with increased caregiver burden, reduced functional ability, and nearly threefold higher mortality.\n\nPD affects over 680,000 Americans today and is projected to impact more than 1.2 million by 2030. It presents with both motor symptoms (e.g., bradykinesia, tremor, rigidity) and non-motor symptoms like depression, anxiety, and apathy. While motor symptoms are often managed with dopaminergic medications and deep brain stimulation (DBS) targeting motor regions (e.g., subthalamic nucleus, globus pallidus internal), apathy typically persists or worsens following these treatments. No FDA-approved or consistently effective treatments exist for apathy in PD. Dopamine agonists may help but have side effects that limit long-term use. SSRIs and cholinesterase inhibitors may be tried for co-occurring depression or cognitive decline, but they are not indicated for apathy and can worsen symptoms or cause adverse effects in PD.\n\nThis protocol proposes targeting apathy in PD using DBS of the ventral capsule\u002Fventral striatum (VC\u002FVS), a region involved in reward processing and goal-directed behavior. VC\u002FVS DBS is FDA-approved under a Humanitarian Device Exemption for OCD and has shown promise in treating depression, addiction, and other disorders involving motivational deficits. Neuroimaging and preclinical models strongly implicate this region in the regulation of goal-directed behavior, reward sensitivity, and cognitive control-mechanisms disrupted in apathy. Stimulating VC\u002FVS may improve motivation through fibers connected to orbitofrontal and anterior cingulate cortices (reward sensitivity) and dorsal prefrontal regions (cognitive control).\n\nSupport for this approach comes from a case report where a patient with PD and OCD received both STN and VC\u002FVS DBS. In addition to motor and OCD symptom improvement, the patient showed a significant reduction in apathy. Apathy worsened when stimulation ceased and improved again when resumed, suggesting a causal relationship. VC\u002FVS DBS was safe, did not impair motor symptoms, and appeared to enhance motivation.\n\nThis study aims to test the safety and efficacy of VC\u002FVS DBS for apathy in PD. Building on extensive animal, imaging, and clinical data, it addresses a major unmet need using an existing DBS platform. The approach is supported by established neurocircuitry, prior clinical experience with VC\u002FVS targeting, and early evidence suggesting potential benefit. It does not duplicate prior studies but extends DBS to a new, underserved indication within PD.",[92,30,674],"Apathy",[676,178,677,678,679,680,681],"parkinson disease","apathy","dbs","pd","neuromodulation","imaging","2025-05-27",{"date":684,"type":36},"2025-05-31",{"date":686,"type":22},"2025-09-01",{"date":688,"type":22},"2032-09-01",{"name":690,"class":43},"Nora Vanegas"]