Adaptive DBS for PD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Pins Medical Co., Ltd

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

60 Participants
are divided into 2 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