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RECRUITING
NCT07635823
NA

Adaptive DBS for PD RCT

Sponsor: Beijing Pins Medical Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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