Cortical Electrophysiology of Response Inhibition in Parkinson's Disease

Trial ID: NCT06234995

Interventional - Phase 4 - Recruiting

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.

Conditions

• Parkinson Disease

Interventions

• Levodopa
• Clinical DBS Setting
• Sham DBS
• DBS Setting Maximizing Prefrontal Activation
• DBS Setting Minimizing Prefrontal Activation

Eligibility

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
• 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
• presence of a coagulopathy
• uncontrolled hypertension
• heart disease
• other medical conditions considered to increase the patient's risk for surgical complications
• diagnosis of idiopathic PD
• functioning DBS system
• 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
• age 45-75
• history of a neuropsychiatric disorder and/or treatment with psychotropic medications
• non-English speaker

Sponsor

Emory University, National Institute of Neurological Disorders and Stroke (NINDS)

Source: ClinicalTrials.gov

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