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Subthalamic Nucleus Versus Globus Pallidal Internus Deep Brain Stimulation for Parkinson Disease
Sponsor: Zhang Jianguo
Summary
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.
Key Details
Gender
All
Age Range
22 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2025-11-24
Completion Date
2027-06-30
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
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). Participants will receive the STN target stimulation protocol for a 3-month treatment period.
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). Participants will receive the GPi target stimulation protocol for a 3-month treatment period.
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). After 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.
Locations (8)
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China