[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623555":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":50,"centralContacts":56,"locations":66,"responsibleParty":86,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":61,"enrollmentInfo":103,"targetDuration":61,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":69,"whyStopped":61,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Nighttime adaptive DBS programming","EXPERIMENTAL","The patient will undergo at-home blinded testing of the single power band N2\u002F3 sleep stage aDBS (e.g 75% \\& 125% conditions, levels chosen for each subject by the clinician or by the study team using data analysis) versus cDBS. Initially the patient will complete \\~2 months (60 nights) of randomized, blinded, single night trials of aDBS at lower amplitude (e.g. 75%; 20 nights), aDBS at higher amplitude (e.g. 125% 20 nights) versus cDBS 100% (20 nights) to detect efficacy at the single subject level in independent N-of-1 trials. Stimulation amplitudes will be personalized and selected for tolerability and by searching for amplitudes that impact sleep physiology during the setup phase. Formal final testing will be completed in randomized, counterbalanced condition blocks. Patients will be in cDBS mode during the daytime and will perform a blinded switch to either cDBS or aDBS in the evening before going to sleep (or using the scheduling app).",[13,14],"Device: Medtronic Percept Deep Brain Stimulation (cDBS)","Device: Medtronic Percept Deep Brain Stimulation (nighttime aDBS)",{"label":16,"type":10,"description":17,"interventionNames":18},"Daytime adaptive DBS Programming","Investigators will conduct a blinded, randomized comparison between the effects of aDBS and clinically optimized cDBS on motor signs and symptoms. Both stimulation conditions will be applied for 1 day, in blocks of 2 days that are randomized and counterbalanced for over 40 days in patients' homes. Patients will be in cDBS mode overnight and will perform a blinded switch to either cDBS or aDBS in the morning on waking (these will appear to the patient as programs C and D). Investigators will utilize patients' daily symptom diaries and wearable data. They will ask patients to complete the symptom diary (an electronic questionnaire) every night before bedtime. This focuses on the total number of hours spent with symptoms, severity, and a quality of life (QoL) score validated for daily assessment of health-related QoL (EQ-5D). Evaluated symptoms include the most bothersome and opposite symptom as well as a range of common motor symptoms including bradykinesia, dyskinesia, tremor, etc...",[13,19],"Device: Medtronic Percept Deep Brain Stimulation (daytime aDBS)",{"label":21,"type":22,"description":23,"interventionNames":24},"Open-loop continuous deep brain stimulation","ACTIVE_COMPARATOR","Participants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation.",[13,19,14],[26,37,45],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Medtronic Percept Deep Brain Stimulation (cDBS)","Using the Percept pulse generator, patients receive clinically-optimized open loop stimulation to the subthalmaic nucleus.",[16,9,21],[32,33,34,35,36],"deep brain stimulation","DBS","cDBS","continuous DBS","continuous deep brain stimulation",{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Medtronic Percept Deep Brain Stimulation (daytime aDBS)","Using the Percept pulse generator, patients receive daytime adaptive stimulation to the subthalmaic nucleus.",[16,21],[42,43,44],"aDBS","adaptive DBS","adaptive deep brain stimulation",{"type":27,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Medtronic Percept Deep Brain Stimulation (nighttime aDBS)","Using the Percept pulse generator, patients receive nighttime adaptive stimulation to the subthalmaic nucleus.",[9,21],[42,43,44],[51,54],{"name":52,"affiliation":5,"role":53},"Simon Little","PRINCIPAL_INVESTIGATOR",{"name":55,"affiliation":5,"role":53},"Philip Starr",[57,63],{"name":58,"role":59,"phone":60,"phoneExt":61,"email":62},"Clinical Research Coordinator","CONTACT","5175152739",null,"sebastian.liu@ucsf.edu",{"name":64,"role":59,"phone":61,"phoneExt":61,"email":65},"Research Manager","sarah.wang@ucsf.edu",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"University of California San Francisco","RECRUITING","San Francisco","California","94158","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-122.41942,37.77493,{"lat":79,"lon":78},[82],{"name":83,"role":59,"phone":84,"phoneExt":61,"email":85},"Sarah Wang, PhD","415-353-7885","Sarah.Wang@ucsf.edu",{"type":53,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"Simon J. Little, MBBS, PhD","Assistant Professor, Clinical Neurology",[90],{"name":91,"class":92},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100623555","simplified-scalable-24-hour-adaptive-dbs-in-parkinsons-disease-100623555",false,"NCT07398157","Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease","Subgaleal Cortical Electrodes in Patients With Parkinson's Disease Undergoing Deep-brain Stimulation Therapy for Sensing and Adaptive Deep-brain Stimulation Over a 24-hour Period.","Subgaleal aDBS","Inclusion criteria\n\n1. Age 25-75.\n2. Diagnosis of idiopathic PD.\n3. Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe).\n4. Patient has requested surgical intervention with deep brain stimulation for their disorder or previous enrollment in sponsored IDE (G220241) to use Percept PC wired to subgaleal sensing, if patients have ongoing daytime fluctuations or sleep dysfunction despite cDBS optimization.\n5. Normal preoperative brain MRI.\n6. Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA).\n7. Signed informed consent.\n8. Motor UPDRS-III off medication score 25 to 65 and a \\>35% improvement with levodopa, predominant rigid\u002Fbradykinetic symptoms (ratio of off-medication UPDRS-III limb rigidity\u002Fbradykinesia scores to limb tremor scores of \\>1.2).\n9. Motor fluctuations despite optimized medical therapy with at least 2 hours per day of either \"off\" time, or \"on\" with dyskinesias.\n10. Ability to comply with study follow-up visits for brain recording, testing of closed-loop stimulation, and clinical assessment.\n\nExclusion criteria\n\n1. Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications.\n2. Patient meets criteria for a psychogenic movement disorder.\n3. Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.\n4. Significant untreated depression (BDI-II score \\>20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).\n5. Any personality or mood symptoms that study personnel believe will interfere with study requirements.\n6. Patient who requires electroconvulsive therapy, repetitive transcranial magnetic stimulation, or diathermy, implanted neurostimulators and MR-incompatible metallic implants, previous craniotomy on the side of the intended subgaleal implant, and drug or alcohol abuse.\n7. Patients who experience adverse effects that are undesirable and detrimental to the health of subjects from DBS or other similar neurostimulators","ALL","18 Years",{"count":104,"type":105},24,"ESTIMATED","INTERVENTIONAL",[108],"NA","The purpose of this study is to test a new way to treat Parkinson's disease (PD). Subjects will be implanted with deep brain stimulator (DBS) devices and electrodes placed under the scalp.\n\nThe main questions it aims to answer are:\n\n* Is there a less invasive method to collect useful brain signals? Find out if these brain signals can be related to movement and\u002For sleep symptoms.\n* How to use these brain signals to tailor adaptive deep brain stimulation settings for movement and\u002For sleep symptoms\n\nResearchers will compare study derived adaptive DBS settings to subject's clinically programmed continuous DBS settings to see which is better at treating patients PD symptoms.",[111],"PD - Parkinson's Disease",[113,114,33],"Subgaleal","adaptive","2026-04-29",{"date":117,"type":118},"2026-05-05","ACTUAL",{"date":120,"type":118},"2026-04-09",{"date":122,"type":105},"2031-11-30",{"name":5,"class":6},1]