Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Parkinson Disease Clinical Trial

Official title:

Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933681
• Other study ID #: 230539
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Vanderbilt University Medical Center
• Contact: Sarah Bick, MD
• Phone: 615-322-1883
• Email: Sarah.Bick[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Parkinson Disease

Intervention

Device:
• Neural recordings and stimulation
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting	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.	Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Primary	Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation	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.	1 hour