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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05933681
Other study ID # 230539
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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