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

Parkinson Disease

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

Inclusion Criteria9

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

Exclusion Criteria14

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
presence of a coagulopathy
uncontrolled hypertension
heart disease
other medical conditions considered to increase the patient's risk for surgical complications
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
history of a neuropsychiatric disorder and/or treatment with psychotropic medications
non-English speaker

Interventions

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.

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.