Cortical Electrophysiology of Response Inhibition in Parkinson's Disease

NCT06234995 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-27

No results posted yet for this study

Summary

Patients with Parkinson's Disease will be studied before, during, and after a deep brain stimulation implantation procedure to see if the stimulation location and the size of the electrical field produced by subthalamic nucleus (STN) DBS determine the degree to which DBS engages circuits that involve prefrontal cortex executive functions, and therefore have a direct impact on the patient's ability to inhibit actions.

Conditions

  • Parkinson Disease

Interventions

DRUG

Levodopa

Participants will take levodopa in dosages prescribed by their care provider. Patients will be instructed to not take their regularly prescribed PD medications for 12 hours prior to the study assessment, as is typical for clinical evaluations in patients with PD. Participants will be tested in both levodopa-off (after 12 hours of not having medication) and levodopa-on states.

DEVICE

Clinical DBS Setting

Deep brain stimulation performed with the patients' optimized clinical setting.

DEVICE

Sham DBS

Deep brain stimulation performed with sham stimulation.

DEVICE

DBS Setting Maximizing Prefrontal Activation

Deep brain stimulation performed to maximize the activation of the prefrontal cortico-STN projections.

DEVICE

DBS Setting Minimizing Prefrontal Activation

Deep brain stimulation performed to minimize the activation of the prefrontal cortico-STN projections.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH
  • Emory University

    lead OTHER

Principal Investigators

  • Svjetlana Miocinovic, MD, PhD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT06234995 on ClinicalTrials.gov