Cortical Electrophysiology of Response Inhibition in Parkinson's Disease

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: t
View:

• diagnosis of idiopathic Parkinson's disease (PD)

• Hoehn and Yahr (H\&Y) stage 2-4 (off medication)

• diagnosis of idiopathic PD

• there is a clinical indication for DBS surgery

• normal preoperative MRI

• ability to tolerate microelectrode-guided neurosurgery in an awake state

• diagnosis of idiopathic PD

• functioning DBS system

• age 45-75

Locations
United States
Georgia
Emory Brain Health Center
RECRUITING
Atlanta
Emory University Hospital
RECRUITING
Atlanta
Contact Information
Primary
Jonna Seppa
jonna.k.seppa@emory.edu
404-727-1509
Backup
Svjetlana Miocinovic, MD, PhD
404-712-9065
Time Frame
Start Date: 2021-08-09
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 80
Treatments
Experimental: Patients with Parkinson's Disease
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 will 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 will be recorded. A cap similar to a swim cap will be placed on the head of the subject, and gel will be applied to the hair to get a good signal. Electrodes will be attached to the cap for recording of brain signals. A few additional flat electrodes will be placed on the skin to record hand muscle activity (for GNG task) and near the eyes to record eye movements. Accelerometer sensors will be 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 will participate for approximately one month, which includes two study visits. As part of the motor inhibition tasks, EEG signals will be recorded. A cap similar to a swim cap will be placed on the head of the subject, and gel will be applied to the hair to get a good signal. Electrodes will be attached to the cap for recording of brain signals. A few additional flat electrodes will be placed on the skin to record hand muscle activity (for GNG task) and near the eyes to record eye movements. Accelerometer sensors will be utilized to record arm movements (for MSS task).
Sponsors
Leads: Emory University
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov