Adaptive DBS for PD

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.

NCT Number	NCT07635823
Lead Sponsor	Beijing Pins Medical Co., Ltd Collaborators: Beijing Tiantan Hospital, Xuanwu Hospital, Beijing, Nanjing Brain Hospital, Qilu Hospital of Shandong University, West China Hospital, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Peking Union Medical College Hospital, Xiangya Hospital of Central South University, First Affiliated Hospital, Sun Yat-Sen University
Conditions	Parkinson Disease(PD)
Enrollment	60 participants
Start Date	2026-05-16
Primary Completion	2027-05-31 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-22