Cortical Electrophysiology of Response Inhibition in Parkinson's Disease

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06234995
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Levodopa — DRUG
    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.
  • Clinical DBS Setting — DEVICE
    Deep brain stimulation performed with the patients' optimized clinical setting.
  • Sham DBS — DEVICE
    Deep brain stimulation performed with sham stimulation.
  • DBS Setting Maximizing Prefrontal Activation — DEVICE
    Deep brain stimulation performed to maximize the activation of the prefrontal cortico-STN projections.
  • DBS Setting Minimizing Prefrontal Activation — DEVICE
    Deep brain stimulation performed to minimize the activation of the prefrontal cortico-STN projections.

Study Details

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.

Key Dates

Start date
Aug 9, 2021
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Patients with Parkinson's Disease (PD)
    Patients with PD complete motor response inhibitions tasks under multiple conditions, depending on the study aim they are participating in. Those who are participants in Aim 1 of the study are able to also participate in Aims 2 and 3 if they are having a clinically indicated DBS leads implanted. Patients with PD participate in the study for approximately 18 months which includes one preoperative visit, intraoperative data collection and two post-operative visits. As part of the motor inhibition tasks, EEG signals are recorded. A cap similar to a swim cap is placed on the head of the subject, and gel is applied to the hair to get a good signal. Electrodes are attached to the cap for recording of brain signals. A few additional flat electrodes are placed on the skin to record hand muscle activity (for GNG task) and near the eyes to record eye movements. Accelerometer sensors are utilized to record arm movements (for MSS task).
  • No Intervention: Healthy Controls
    Healthy participants complete motor response inhibition tasks during two study visits. Healthy controls participate for approximately one month, which includes two study visits. As part of the motor inhibition tasks, EEG signals are recorded. A cap similar to a swim cap is placed on the head of the subject, and gel is applied to the hair to get a good signal. Electrodes are attached to the cap for recording of brain signals. A few additional flat electrodes are placed on the skin to record hand muscle activity (for GNG task) and near the eyes to record eye movements. Accelerometer sensors are utilized to record arm movements (for MSS task).

Primary Outcome Measure

Response Time During Go/No-Go (GNG) Task for Participants in Aim 1 [ Time Frame: Day 1 (before and after levodopa dosage for persons with PD) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory Brain Health CenterAtlantaGeorgia30329-
Emory University HospitalAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Emory Brain Health Center· Atlanta, GAEmory University Hospital· Atlanta, GA

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