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Recruiting Phase 4 NCT06234995

NCT06234995 Cortical Electrophysiology of Response Inhibition in Parkinson's Disease

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Clinical Trial Summary
NCT ID NCT06234995
Status Recruiting
Phase Phase 4
Sponsor Emory University
Condition Parkinson Disease
Study Type INTERVENTIONAL
Enrollment 80 participants
Start Date 2021-08-09
Primary Completion 2026-07

Trial Parameters

Condition Parkinson Disease
Sponsor Emory University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 80
Sex ALL
Min Age 45 Years
Max Age 75 Years
Start Date 2021-08-09
Completion 2026-07
Interventions
LevodopaClinical DBS SettingSham DBS

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Brief 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 Criteria

Inclusion Criteria for Persons with Parkinson's Disease for Aim 1: * diagnosis of idiopathic Parkinson's disease (PD) * Hoehn and Yahr (H\&Y) stage 2-4 (off medication) Exclusion Criteria for Persons with Parkinson's Disease for Aim 1: * severe tremor at rest or severe dyskinesia which would cause significant artifacts in electrophysiological signals * inability to hold antiparkinsonian medications for research recordings * dementia * non-English speaker Inclusion Criteria for Persons with Parkinson's Disease for Aim 2: * 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 Exclusion Criteria for Persons with Parkinson's Disease for Aim 2: * presence of a coagulopathy * uncontrolled hypertension * heart disease * other medical conditions considered to increase the patient's risk for surgical complications Inclusion Criteria for Persons with Parkinson's Disease for

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