[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612215":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":141,"collaborators":27,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":27,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":169,"whyStopped":27,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Beijing Municipal Administration of Hospitals","OTHER_GOV",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"First STN-DBS group","EXPERIMENTAL","Treatment involves deep brain electrode implantation with the STN target stimulation protocol.Stimulator activation time: To avoid the impact of local cerebral edema and microlesional effects after electrode implantation on clinical efficacy assessment, the STN target stimulator will be activated at the first follow-up visit.Postoperative medication: During the study period, patients are not prohibited from using drug therapy. Existing therapeutic drugs may be adjusted or new drugs for Parkinson's disease may be added.At the second follow-up visit, patients will receive the GPi target stimulation protocol.At the third follow-up visit, patients will receive the simultaneous STN + GPi stimulation protocol.At the final follow-up visit, the most clinically satisfactory stimulation protocol will be selected based on the patient's specific condition.Washout period: All patients will switch to GPi target therapy 90 days after receiving STN target stimulation.",[13,14,15],"Device: STN-DBS stimulation","Device: GPi-DBS stimulation","Device: STN&GPi-DBS stimulation",{"label":17,"type":18,"description":19,"interventionNames":20},"First GPi-DBS group","ACTIVE_COMPARATOR","Treatment involves deep brain electrode implantation with the GPi target stimulation protocol.Stimulator activation time: To avoid the impact of local cerebral edema and microlesional effects after electrode implantation on clinical efficacy assessment, the GPi target stimulator will be activated at the first follow-up visit.Postoperative medication: During the study period, patients are not prohibited from using drug therapy. Existing therapeutic drugs may be adjusted or new drugs for Parkinson's disease may be added.At the second follow-up visit, patients will receive the STN target stimulation protocol.At the third follow-up visit, patients will receive the simultaneous STN + GPi stimulation protocol.At the final follow-up visit, the most clinically satisfactory stimulation protocol will be selected based on the patient's specific condition.Washout period: All patients will switch to STN target therapy 90 days after receiving GPi target stimulation.",[13,14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","STN-DBS stimulation","The devices for this study are provided by Boston Scientific International Medical Trading (Shanghai) Co., Ltd.The system consists of two components: electrodes and an implanted stimulator.Participants will be implanted with an 8-contact directional electrode (Model: DB-2202-45).The stimulator is a rechargeable model (Model: DB-1232).\n\nParticipants will receive the STN target stimulation protocol for a 3-month treatment period.",[17,9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"GPi-DBS stimulation","The devices for this study are provided by Boston Scientific International Medical Trading (Shanghai) Co., Ltd.The system consists of two components: electrodes and an implanted stimulator.Participants will be implanted with an 8-contact directional electrode (Model: DB-2202-45).The stimulator is a rechargeable model (Model: DB-1232).\n\nParticipants will receive the GPi target stimulation protocol for a 3-month treatment period.",[17,9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"STN&GPi-DBS stimulation","The devices for this study are provided by Boston Scientific International Medical Trading (Shanghai) Co., Ltd.The system consists of two components: electrodes and an implanted stimulator.Participants will be implanted with an 8-contact directional electrode (Model: DB-2202-45).The stimulator is a rechargeable model (Model: DB-1232).\n\nAfter participants receive 3 months of STN target monotherapy and 3 months of GPi target monotherapy sequentially, they will be administered the combined STN + GPi target stimulation protocol. Prior to the initiation of simultaneous STN + GPi stimulation, participants are required to turn off the stimulator for 4 hours to eliminate the residual effects of the previous target stimulation.",[17,9],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Rujin Wang","CONTACT","+8618101287707","reganwang1223@gmail.com",[43,64,74,84,94,104,114,128],{"facility":44,"status":27,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Beijing Tiantan Hospital Affiliated to Capital Medical University","Beijing","Beijing Municipality","100070","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57,59,62],{"name":38,"role":39,"phone":58,"phoneExt":27,"email":41},"18101287707",{"name":60,"role":61,"phone":27,"phoneExt":27,"email":27},"Anchao Yang","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":27,"phoneExt":27,"email":27},"Guanyu Zhu",{"facility":65,"status":27,"city":66,"state":67,"zip":68,"country":48,"countryCode":49,"cosmosGeoPoint":69,"geoPoint":73,"contacts":27},"Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology","Wuhan","Hubei","430030",{"type":51,"coordinates":70},[71,72],114.26667,30.58333,{"lat":72,"lon":71},{"facility":75,"status":27,"city":76,"state":77,"zip":78,"country":48,"countryCode":49,"cosmosGeoPoint":79,"geoPoint":83,"contacts":27},"Nanjing Brain Hospital","Nanjing","Jiangsu","210029",{"type":51,"coordinates":80},[81,82],118.77778,32.06167,{"lat":82,"lon":81},{"facility":85,"status":27,"city":86,"state":87,"zip":88,"country":48,"countryCode":49,"cosmosGeoPoint":89,"geoPoint":93,"contacts":27},"The First Affiliated Hospital of Dalian Medical University","Dalian","Liaoning","116011",{"type":51,"coordinates":90},[91,92],121.60222,38.91222,{"lat":92,"lon":91},{"facility":95,"status":27,"city":96,"state":97,"zip":98,"country":48,"countryCode":49,"cosmosGeoPoint":99,"geoPoint":103,"contacts":27},"Qilu Hospital of Shandong University","Jinan","Shandong","250012",{"type":51,"coordinates":100},[101,102],116.99722,36.66833,{"lat":102,"lon":101},{"facility":105,"status":27,"city":106,"state":107,"zip":108,"country":48,"countryCode":49,"cosmosGeoPoint":109,"geoPoint":113,"contacts":27},"Changhai Hospital of Shanghai","Shanghai","Shanghai Municipality","200120",{"type":51,"coordinates":110},[111,112],121.45806,31.22222,{"lat":112,"lon":111},{"facility":115,"status":27,"city":116,"state":117,"zip":118,"country":48,"countryCode":49,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Tianjin Huanhu Hospital","Tianjin","Tianjin Municipality","300350",{"type":51,"coordinates":120},[121,122],117.17667,39.14222,{"lat":122,"lon":121},[125],{"name":126,"role":127,"phone":27,"phoneExt":27,"email":27},"Siquan Liang","PRINCIPAL_INVESTIGATOR",{"facility":129,"status":27,"city":130,"state":131,"zip":132,"country":48,"countryCode":49,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"The Second Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang","310009",{"type":51,"coordinates":134},[135,136],120.16142,30.29365,{"lat":136,"lon":135},[139],{"name":140,"role":127,"phone":27,"phoneExt":27,"email":27},"Junming Zhu",{"type":142,"investigatorFullName":143,"investigatorTitle":144,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Zhang Jianguo","Deputy Director of the Neurosurgery Center,Director of the Functional Neurosurgery Ward,Director of the Neural Function Laboratory","100612215","subthalamic-nucleus-versus-globus-pallidal-internus-deep-brain-stimulation-for-parkinson-disease-100612215",false,"NCT07250685","Subthalamic Nucleus Versus Globus Pallidal Internus Deep Brain Stimulation for Parkinson Disease","Superior PD","Inclusion Criteria:\n\n1. Age at the time of enrollment: 22-75 years.\n2. Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia\n3. Duration of idiopathic PD: ≥ 5 years.\n4. Severity of PD in the meds off condition: Hoehn-Yahr stages 2.5\\~ 4.0.\n5. Despite optimal medication treatment, there are still persistent symptoms or drug side effects of disabling Parkinson's\n6. Must have tried a form of carbidopa\u002Flevodopa and\u002For one of the dopamine agonists as part of medication therapy.\n7. Anti-parkinsonian medications must improve PD symptoms by ≥33%, as measured by UPDRS-III score.\n8. UPDRS-III score of ≥ 30 in the meds off condition.\n9. The MMSE assessment was higher than the demarcation score of the corresponding educational level, and the cognitive function was normal.\n10. HAMD score≤24.\n11. No change in antidepressant medications utilized for treatment of depression for at least 8 weeks prior to informed consent.\n12. Stable on anti-parkinsonian medication for 28 days prior to informed consent.\n13. Could tolerate bilateral STN DBS and bilateral GPi DBS.\n14. Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system and completing the PD Diary\n15. Able to understand the study requirements and the treatment procedures and provides written informed consent before any studyspecific tests or procedures are performed.\n\nExclusion Criteria:\n\n1. Any intracranial abnormalities or medical conditions that Lead to the prohibition of DBS surgery.\n2. Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders).\n3. HAMD score\\>24.\n4. Any current drug or alcohol abuse, per DSM-IV criteria\n5. Any history of recurrent or unprovoked seizures.\n6. Any history of hemorrhagic stroke.\n7. Any previous treatment for movement disorders involving intracranial surgery or device implantation.\n8. Any other active implanted devices including neurostimulators (e.g., cochlear implant, pacemaker) and \u002For drug delivery pumps, whether turned on or off. Passive implants (e.g., knee prostheses) would be allowed provided that they do not interfere with the functioning of the DBS system\n9. Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.\n10. Any previously implanted Vagus Nerve Stimulation (VNS) patients.\n11. Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.\n12. A condition requiring or likely to require the use of Magnetic Resonance Imaging (MRI), diathermy or electroconvulsive therapy (ECT)\n13. Likely to require the use of monopolar cau Likely to require the use of monopolar cautery, radiofrequency (RF) procedures, external defibrillation, lithotripsy, radiation therapy or transcranial stimulation.tery, radiofrequency (RF) procedures, external defibrillation, lithotripsy, radiation therapy or transcranial stimulation.\n14. Currently on any anticoagulant medications that cannot be discontinued during perioperative period.\n15. Currently exhibiting secondary Parkinsonism due to prescribed medications.\n16. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.\n17. Any terminal illness with life expectancy of \\\u003C 1 year.\n18. Any unresolved infection, a coagulopathy or significant cardiac or other medical risk factor for surgery\n19. Current or future risk of being immunocompromised that might significantly increase risk of infection.\n20. Participation in any other clinical trial (e.g. drug, device, or biologics) concurrently or within the preceding 30 days. Participation in any other study will be allowed per investigator\u002Fsponsor discretion only.\n21. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.\n22. Preoperative DBS plan failed to implant STN and GPi. nuclei.(Usually limited by individual anatomical differences)\n23. Preoperative CT scan of the head revealed calcification of the GPI.","ALL","22 Years","75 Years",{"count":156,"type":157},86,"ESTIMATED","INTERVENTIONAL",[160],"NA","The primary objective of this prospective, multicenter, double-blind, randomized, crossover clinical trial is to evaluate whether Subthalamic Nucleus-Deep Brain Stimulation (STN-DBS) is more effective than Globus Pallidus Internus-Deep Brain Stimulation (GPi-DBS) in improving motor symptoms of patients with Parkinson's disease at 90 days post-treatment.",[163],"PD - Parkinson's Disease",[165,166,167,168],"Parkinson's disease(PD)","Deep Brain Stimulation(DBS)","Subthalamic Nucleus(STN)","Globus Pallidus Internus(GPi)","NOT_YET_RECRUITING","2025-11-18",{"date":172,"type":173},"2025-11-26","ACTUAL",{"date":175,"type":157},"2025-11-24",{"date":177,"type":157},"2027-06-30",{"name":143,"class":6},8]