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NOT YET RECRUITING
NCT07250685
NA

Subthalamic Nucleus Versus Globus Pallidal Internus Deep Brain Stimulation for Parkinson Disease

Sponsor: Zhang Jianguo

View on ClinicalTrials.gov

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

Interventions

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). Participants will receive the STN target stimulation protocol for a 3-month treatment period.

DEVICE

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.

DEVICE

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