Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neural recordings and stimulation

Device

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.

Primary outcomes

Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting

Time frame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours

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.
Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation

Time frame: 1 hour

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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

United States Department of Defense

Registry information

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2027
First posted: Jul 6, 2023
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting