RecruitingPhase 4NCT06234995

Cortical Electrophysiology of Response Inhibition in Parkinson's Disease


Sponsor

Emory University

Enrollment

80 participants

Start Date

Aug 9, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This research study is investigating the brain activity involved in stopping movements (response inhibition) in people with Parkinson's disease, using brain recordings. Some participants may be studied during deep brain stimulation (DBS) surgery. **You may be eligible if...** - You have been diagnosed with Parkinson's disease - You are in moderate stages of the disease (Hoehn and Yahr stage 2–4, off medication) - Some participants may be eligible if they are scheduled for DBS surgery or already have a functioning DBS device **You may NOT be eligible if...** - You have severe uncontrollable tremors or movements that would interfere with recordings - You have dementia - You are a non-English speaker - For surgical participants: you have uncontrolled high blood pressure, heart disease, or bleeding disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLevodopa

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.

DEVICEClinical DBS Setting

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

DEVICESham DBS

Deep brain stimulation performed with sham stimulation.

DEVICEDBS Setting Maximizing Prefrontal Activation

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

DEVICEDBS Setting Minimizing Prefrontal Activation

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


Locations(2)

Emory University Hospital

Atlanta, Georgia, United States

Emory Brain Health Center

Atlanta, Georgia, United States

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NCT06234995


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