Adaptive DBS for PD RCT

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

Eligibility

Inclusion Criteria: * idiopathic Parkinson's disease * Hoehn \& Yahr (HY) stage 2.5-4 during medication "OFF" * Subjects must meet one of the following: 1. Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery; 2. Previous bilateral STN/GPi DBS recipients with only one

Locations