Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Not Applicable

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT05933681
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study Start: 2023-07-06
• Study First Posted: 2023-07-06
• Primary Completion: 2025-07-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-22
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States