Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Vanderbilt University Medical Center

Status: Active, not recruiting

Conditions: Parkinson Disease

Treatments: Device: Neural recordings and stimulation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05933681

230539

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment

Experimental group

Description:

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.

Treatment:

Device: Neural recordings and stimulation

Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation

Experimental group

Description:

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.

Treatment:

Device: Neural recordings and stimulation