Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled 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.
• idiopathic Parkinson's disease
• Hoehn \& Yahr (HY) stage 2.5-4 during medication OFF
• Subjects must meet one of the following:
‣ Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;
⁃ Previous bilateral STN/GPi DBS recipients with only one IPG who:
• Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,
• Consent to device replacement with G1010R DBS system.
• Willing and physically/mentally able to complete all study visits and procedures
• Capable of comprehending and providing written informed consent