Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
NCT05992701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-12-10
Summary
The purpose of this study is to demonstrate the safety and effectiveness of the PINS Deep Brain Stimulation (DBS) system, including the G107R/G107 IPG, L305/L306 directional leads, E204 extensions and related system components.
Conditions
Interventions
- DEVICE
-
Directional deep brain stimualtion
Directional deep brain stimualtion in the treatment of Parkinson's disease using L305/L306 leads and G107R/G107 implanted pulse generators (Beijing Pins Medical Co.).
Sponsors & Collaborators
-
Beijing Tiantan Hospital
collaborator OTHER -
Changhai Hospital, the Second Military Medical University
collaborator UNKNOWN -
Shenzhen Second People's Hospital
collaborator OTHER -
Zhongnan Hospital
collaborator OTHER -
West China Hospital
collaborator OTHER -
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
collaborator UNKNOWN -
First Affiliated Hospital of Kunming Medical University
collaborator OTHER -
Nanjing Medical University
collaborator OTHER -
Tianjin Medical University General Hospital
collaborator OTHER -
Beijing Pins Medical Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-28
- Primary Completion
- 2023-11-13
- Completion
- 2023-12-23
Countries
- China
Study Locations
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