About this trial
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.
Eligibility criteria
Qualifiers
idiopathic Parkinson's disease
Hoehn & Yahr (HY) stage 2.5-4 during medication "OFF"
Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;
Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,
Disqualifiers
Presence of contraindications to deep brain stimulation (DBS) surgery.
Beck Depression Inventory-II (BDI-II) score > 25
Mini-Mental State Examination (MMSE) score < 24 (adjusted for educational level)
Significant comorbidities that may interfere with DBS therapy per investigator assessment.
Trial design
Treatments tested in this trial
- adaptive deep brain stimulation
- conventional deep brain stimulation
Treatment groups
Sponsors and collaborators
Beijing Pins Medical Co., Ltd
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Nanjing Brain Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
West China Hospital
Collaborator
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Collaborator
Peking Union Medical College Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator