[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641284":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":38,"centralContacts":39,"locations":49,"responsibleParty":168,"collaborators":170,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":186,"sex":192,"minAge":193,"maxAge":38,"enrollmentInfo":194,"targetDuration":38,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":69,"whyStopped":38,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"fullName":5,"class":6},"Beijing Pins Medical Co., Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Participants in this group will first take conventional DBS treatment for 30-45 days, then change to adaptive DBS treatment for another 30-45 days.",[13,14],"Device: adaptive deep brain stimulation","Device: conventional deep brain stimulation",{"label":16,"type":10,"description":17,"interventionNames":18},"Group B","Participants in this group will first take adaptive DBS treatment for 30-45 days, then change to conventional DBS treatment for another 30-45 days.",[13,14],[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","adaptive deep brain stimulation","adaptive deep brain stimulation (aDBS) is a stimulation mode that measuring local field potential (LFP) signal nearby the electrodes of lead in the deep brain and decoding the signal in real-time, automatically adjusts amplitude of stimulation controlled by algorithm embedded in DBS device. aDBS is able to recognize patient status and allocate proper stimulation parameters based on need to treat Parkinson symptoms.",[9,16],[26,27,28],"closed-loop deep brain stimulation","aDBS","adaptive DBS",{"type":21,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"conventional deep brain stimulation","conventional deep brain stimulation is a common stimulation mode that has been used for years. It uses fixed stimulation parameters to treat Parkinson's disease and has been proved effective to motor symptoms.",[9,16],[34,35,36,37],"cDBS","traditional deep brain stimulation","conventional DBS","open-loop DBS",null,[40,45],{"name":41,"role":42,"phone":43,"phoneExt":38,"email":44},"Jianguang Sun","CONTACT","+86 010-60736388","sunjianguang@pinsmedical.com",{"name":46,"role":42,"phone":47,"phoneExt":38,"email":48},"Qihang Shi","+86 18511837185","shiqihang@pinsmedical.com",[50,67,84,95,103,118,130,144,156],{"facility":51,"status":52,"city":53,"state":54,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"The First Affiliated Hospital of USTC (Anhui Provincial Hospital)","NOT_YET_RECRUITING","Hefei","Anhui","China","CN",{"type":58,"coordinates":59},"Point",[60,61],117.28083,31.86389,{"lat":61,"lon":60},[64],{"name":65,"role":66,"phone":38,"phoneExt":38,"email":38},"Chaoshi Niu","PRINCIPAL_INVESTIGATOR",{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":55,"countryCode":56,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Beijing Tiantan Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","10000",{"type":58,"coordinates":74},[75,76],116.39723,39.9075,{"lat":76,"lon":75},[79,82],{"name":80,"role":42,"phone":81,"phoneExt":38,"email":38},"Hutao Xie","+86 18756921517",{"name":83,"role":66,"phone":38,"phoneExt":38,"email":38},"Jianguo Zhang",{"facility":85,"status":69,"city":70,"state":71,"zip":72,"country":55,"countryCode":56,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},"Xuanwu Hospital, Capital Medical University",{"type":58,"coordinates":87},[75,76],{"lat":76,"lon":75},[90,93],{"name":91,"role":42,"phone":92,"phoneExt":38,"email":38},"Kailiang Wang","+86 13521539544",{"name":94,"role":66,"phone":38,"phoneExt":38,"email":38},"Guoguang Zhao",{"facility":96,"status":52,"city":70,"state":71,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Peking Union Medical College Hospital",{"type":58,"coordinates":98},[75,76],{"lat":76,"lon":75},[101],{"name":102,"role":66,"phone":38,"phoneExt":38,"email":38},"Yi Guo",{"facility":104,"status":52,"city":105,"state":106,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"First Affiliated Hospital, Sun Yat-Sen University","Guangzhou","Guangdong",{"type":58,"coordinates":108},[109,110],113.25,23.11667,{"lat":110,"lon":109},[113,115],{"name":114,"role":66,"phone":38,"phoneExt":38,"email":38},"Jinsheng Zeng",{"name":116,"role":117,"phone":38,"phoneExt":38,"email":38},"Ling Chen","SUB_INVESTIGATOR",{"facility":119,"status":69,"city":120,"state":121,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Xiangya Hospital of Central South University","Changsha","Hunan",{"type":58,"coordinates":123},[124,125],112.97087,28.19874,{"lat":125,"lon":124},[128],{"name":129,"role":66,"phone":38,"phoneExt":38,"email":38},"Zhiquan Yang",{"facility":131,"status":69,"city":132,"state":133,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Nanjing Brain Hospital","Nanjing","Jiangsu",{"type":58,"coordinates":135},[136,137],118.77778,32.06167,{"lat":137,"lon":136},[140,142],{"name":141,"role":42,"phone":38,"phoneExt":38,"email":38},"Chang Qiu",{"name":143,"role":66,"phone":38,"phoneExt":38,"email":38},"Wenbin Zhang",{"facility":145,"status":52,"city":146,"state":147,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Qilu Hospital of Shandong University","Jinan","Shandong",{"type":58,"coordinates":149},[150,151],116.99722,36.66833,{"lat":151,"lon":150},[154],{"name":155,"role":66,"phone":38,"phoneExt":38,"email":38},"Weiguo Li",{"facility":157,"status":52,"city":158,"state":159,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"West China Hospital","Chengdu","Sichuan",{"type":58,"coordinates":161},[162,163],104.06667,30.66667,{"lat":163,"lon":162},[166],{"name":167,"role":66,"phone":38,"phoneExt":38,"email":38},"Wei Wang",{"type":169,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[171,174,176,178,179,180,181,182,183],{"name":172,"class":173},"Beijing Tiantan Hospital","OTHER",{"name":175,"class":173},"Xuanwu Hospital, Beijing",{"name":131,"class":177},"UNKNOWN",{"name":145,"class":173},{"name":157,"class":173},{"name":51,"class":177},{"name":96,"class":173},{"name":119,"class":173},{"name":104,"class":173},"100641284","adaptive-dbs-for-pd-100641284",false,"NCT07635823","Adaptive DBS for PD","Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial","SMART-DBS","Inclusion Criteria:\n\n* idiopathic Parkinson's disease\n* Hoehn \\& Yahr (HY) stage 2.5-4 during medication \"OFF\"\n* Subjects must meet one of the following:\n\n  1. Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;\n  2. Previous bilateral STN\u002FGPi DBS recipients with only one IPG who:\n* Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,\n* Consent to device replacement with G1010R DBS system.\n* Willing and physically\u002Fmentally able to complete all study visits and procedures\n* Capable of comprehending and providing written informed consent\n\nExclusion Criteria:\n\n* Presence of contraindications to deep brain stimulation (DBS) surgery.\n* Beck Depression Inventory-II (BDI-II) score \\> 25\n* Mini-Mental State Examination (MMSE) score \\\u003C 24 (adjusted for educational level)\n* Significant comorbidities that may interfere with DBS therapy per investigator assessment.\n* Pre-existing active non-DBS medical implants or metallic cranial implants\n* Requirement for diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT) during the study period\n* History of ablative neurosurgery or stem cell therapy for Parkinson's disease\n* Inability to complete ≥3 consecutive days of comprehensive motor\u002Fsleep diaries\n* Inability to maintain prescribed medication regimens or comply with protocol requirements\n* Current pregnancy, lactation, or planned pregnancy during the study period\n* Other conditions deemed by investigators to compromise study suitability\n* Participation in other interventional clinical trials within 4 weeks prior to consent","ALL","18 Years",{"count":195,"type":196},60,"ESTIMATED","INTERVENTIONAL",[199],"NA","The goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms. Researchers will compare closed-loop stimulation (which automatically adjusts therapy using real-time brain signals and sleep monitoring) against traditional continuous stimulation (fixed settings) in a randomized, double-blind, crossover study. Participants will undergo surgical implantation of PINS Medical's G1010R neurostimulator, followed by alternating treatment phases where each patient experiences both aDBS and conventional open-loop stimulation modes. Outcomes will assess improvements in without troublesome dyskinesia daily time, motor symptoms (e.g., tremors, rigidity), quality of life, and sleep quality across both therapy periods.",[202],"Parkinson Disease(PD)",[204,205,206,207,208],"Parkinson Disease","Deep brain stimulation","Adaptive DBS","Close-loop DBS","Dyskinesia","2026-06-17",{"date":211,"type":212},"2026-06-22","ACTUAL",{"date":214,"type":212},"2026-05-16",{"date":216,"type":196},"2027-09-30",{"name":5,"class":6},9]