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

Sponsor
Mallory Hacker
Study ID
NCT06008717
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • active subthalamic nucleus deep brain stimulation plus optimal drug therapy — DEVICE
    active subthalamic nucleus deep brain stimulation (DBS) plus optimal drug therapy
  • inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy — DEVICE
    optimal drug therapy alone with DBS device turned off

Study Details

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).

Key Dates

First listed
Aug 24, 2023
Start date
Jan 1, 2028
Status verified
Feb 2026
Primary completion
Dec 31, 2032
Completion
Dec 31, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: active subthalamic nucleus deep brain stimulation plus optimal drug therapy
    active subthalamic nucleus deep brain stimulation; plus optimal drug therapy
  • Active Comparator: inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy
    inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy

Primary Outcome Measure

frequency and severity of adverse events [ Time Frame: 24 months ]

Central Contacts

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