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NOT YET RECRUITING
NCT06008717
NA

Double-Blind Clinical Trial of Subthalamic Nucleus Deep Brain Stimulation in Early-Stage Parkinson's Disease

Sponsor: Mallory Hacker

View on ClinicalTrials.gov

Summary

The goal of this trial is to evaluate the preliminary safety and efficacy of programming to maximize stimulation of the dorsolateral region of the subthalamic nucleus (STN) receiving primary motor (M1) and supplementary motor area (SMA), but not pre-SMA, input deep brain stimulation (DBS) in patients with early-stage Parkinson's disease (PD).

Official title: A Prospective, Randomized Feasibility Clinical Trial Evaluating Bilateral Stimulation of the Dorsolateral Region of the Subthalamic Nucleus Receiving Hyperdirect (M1/SMA) Input in Subjects With Early-Stage Parkinson's Disease

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2028-01-01

Completion Date

2032-12-31

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DEVICE

active subthalamic nucleus deep brain stimulation plus optimal drug therapy

active subthalamic nucleus deep brain stimulation (DBS) plus optimal drug therapy

DEVICE

inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy

optimal drug therapy alone with DBS device turned off