NCT06008717

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mallory Hacker · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2028-01-01
• Primary completion: 2032-12-31
• Completion: 2032-12-31
• First posted: 2023-08-24
• Last updated: 2026-02-20

Regulatory

• FDA-regulated device study