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

NCT06008717 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Mallory Hacker

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-01-01
Primary Completion
2032-12-31
Completion
2032-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06008717 on ClinicalTrials.gov