Neurophysiology Biomarkers of Cognitive Impairment Associated with Deep Brain Stimulation

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Neural recordings and stimulation

• 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
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

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

Arm && Interventions

Group	Intervention	Description
Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment	Neural recordings and stimulation	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.
Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation	Neural recordings and 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.

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