Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Study Overview
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Brief Summary
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The study aims to investigate cognitive impairment associated with Deep Brain Stimulation (DBS) in Parkinson's Disease patients, with a focus on identifying neurophysiology biomarkers of DBS associated cognitive changes. Using neurophysiology data recorded during DBS surgeries and post-implantation, the research intends to identify biomarkers in order to optimize electrode placement, enhance programming, and ultimately minimize DBS-related cognitive side effects.

Official Title
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Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Neural recordings and stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center (Arm 1) Active deep brain stimulation system with implantable pulse generator capable of recording local field potentials (Arm 2) Diagnosis of Parkinson's disease as determined by a movement disorders specialist neurologist Age at least 18 Able to participate in intraoperative testing English speaking Exclusion Criteria: Age less than 18 Not able to participate in intraoperative testing (ex unable to comprehend instructions or follow directions)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment<br>Neurophysiology recordings will be performed from dorsolateral prefrontal cortex (DLPFC) during deep brain stimulation surgery, with and without STN or GPI stimulation, at rest and during a working memory task. | Device: Neural recordings and stimulation<br>* Neural activities from the dorsolateral prefrontal cortex and implanted DBS generator will be recorded, during resting and working memory tasks, and with the DBS target turned on and off.<br>|
| Experimental: Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation<br>Neurophysiology recordings will be performed from subthalamic nucleus (STN) or globus pallidus internus (GPI) with stimulation on and off, at rest and during a working memory task, in patients who have previously been implanted with DBS and have implantable pulse generators capable of recording local field potentials. | Device: Neural recordings and stimulation<br>* Neural activities from the dorsolateral prefrontal cortex and implanted DBS generator will be recorded, during resting and working memory tasks, and with the DBS target turned on and off.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting | Working memory tasked will be conducted during surgery, and local field potentials (LFPs) will be recorded from the DLPFC both at rest and during task execution, under two conditions: with and without stimulation. | Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours | 
| Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation | Local field potentials will be recorded from subthalamic nucleus or globus pallidus internus in patients with an existing DBS system with implantable pulse generator capable of recording local field potentials. Recordings will be performed at rest and during a working memory task, with DBS on and off. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive impairment, Movement Disorders, Brain Diseases, Deep Brain Stimulation, Parkinson Disease