Vanderbilt Clinical Trials

Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Purpose

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.

Condition

Parkinson Disease

Eligibility

Eligible Ages: Over 40 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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)

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Basic Science
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment	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 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.
Experimental Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation	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 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.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Contact:
Sarah Bick, MD
615-322-1883
Sarah.Bick@vumc.org

More Details

Status: Recruiting
Sponsor: Vanderbilt University Medical Center

Study Contact

Sarah Bick, MD
615-322-1883
Sarah.Bick@vumc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.