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Clinical Trials/NCT05933681
NCT05933681
Active, Not Recruiting
N/A

Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Vanderbilt University Medical Center1 site in 1 country160 target enrollmentJuly 6, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Vanderbilt University Medical Center
Enrollment
160
Locations
1
Primary Endpoint
Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting
Status
Active, Not Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 6, 2023
End Date
May 30, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Bick

Assistant Professor of Neurosurgery

Vanderbilt University Medical Center

Eligibility Criteria

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)

Outcomes

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.

Study Sites (1)

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