RECRUITING Phase 4 ClinicalTrials.gov

Cortical Electrophysiology of Response Inhibition in Parkinson's Disease

Sponsor: Emory University • ClinicalTrials.gov ID: NCT06234995

Registry updated: 2026-09-03

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Description

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.

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.

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 Aim 3: * diagnosis of idiopathic PD * functioning DBS system Exclusion Criteria for Persons with Parkinson's Disease for Aim 3: * severe tremor at rest or severe dyskinesia which would cause significant artifacts in electrophysiological signals * inability to hold antiparkinsonian medications for research recordings * inability to tolerate temporary discontinuation of DBS therapy or alteration of stimulation settings for research purposes * other medical conditions considered to increase the patient's risk for surgical complications Inclusion Criteria for Healthy Controls: * age 45-75 Exclusion Criteria for Healthy Controls: * history of a neuropsychiatric disorder and/or treatment with psychotropic medications * non-English speaker

Conditions

Parkinson Disease

Locations

Emory University Hospital — Atlanta, Georgia, United States
Emory Brain Health Center — Atlanta, Georgia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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