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Adaptive DBS for PD RCT
Sponsor: Beijing Pins Medical Co., Ltd
Summary
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.
Official title: Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-05-16
Completion Date
2027-09-30
Last Updated
2026-06-09
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (9)
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
West China Hospital
Chengdu, Sichuan, China