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

Mallory Hacker0 sites40 target enrollmentJanuary 1, 2028

Interventionsactive subthalamic nucleus deep brain stimulation plus optimal drug therapy inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy

Overview

Phase: N/A
Intervention: active subthalamic nucleus deep brain stimulation plus optimal drug therapy
Conditions: Parkinson Disease
Sponsor: Mallory Hacker
Enrollment: 40
Primary Endpoint: frequency and severity of adverse events
Status: Not Yet Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

January 1, 2028

End Date

December 31, 2032

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mallory Hacker

Responsible Party

Sponsor Investigator

Principal Investigator

Mallory Hacker

Assistant Professor of Neurology

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

•A clinical diagnosis of idiopathic Parkinson's disease (PD). The diagnosis will be based upon the presence of at least two of the three cardinal motor signs of this disorder (akinesia/bradykinesia, rest tremor, and rigidity) with at least one of the signs being rest tremor or bradykinesia.
•Clear and dramatic beneficial response to dopaminergic therapy, defined as ≥30% in UPDRS III with administration of the patient's medication during the screening neurological examination.
•Hoehn and Yahr (H\&Y) stage II when OFF medication.
•No contraindications to surgery (i.e., subject does not have uncontrollable medical or psychiatric illness;

Exclusion Criteria

•Age between 50 and 75 years old.
•Dopaminergic therapy for greater than one year and less than four years.
•Available for follow-up for the entire duration of the study.
•Informed Consent (Appendix C): The subject is willing and able to provide written informed consent.
•MRI within normal range (Exclusion Criteria).
•Subjects receiving antidepressant medication used specifically for the treatment of depression must be on stable doses for at least eight weeks prior to enrolling in the study.
•Subjects must agree to maintain a stable regimen, if deemed medically appropriate by the treating physician, of any psychotropic medications throughout the blinded treatment phase.
•Exclusion Criteria:
•Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by:
•Features unusual early in the clinical course (e.g., prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset)