Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment

Parkinson Disease Clinical Trial

Official title:

Corticostriatal Neurophysiology in Parkinson's Disease Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04715984
• Other study ID #: 201868
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: February 2026

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 goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• 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

• Planned clinical electrode trajectory that contacts caudate

• Age greater than or equal to 40

• Diagnosis of Parkinson's disease

• Able to participate in intraoperative testing

• English speaking

Exclusion criteria:

• Age less than 40

• Not able to participate in intraoperative testing (for example unable to comprehend instructions or follow directions)

• Movement disorder other than Parkinson's disease

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Parkinson Disease

Intervention

Other:
• Neurophysiology recordings
Neurophysiology recordings will be performed during deep brain stimulation surgery and their relationship to performance on a working memory task evaluated

Procedure:
• Neural stimulation
Neural stimulation will be delivered during a working memory task and its impact on task performance quantified

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	Changes in caudate DLPFC beta coherence	Caudate DLPFC coherence will be computed at rest and during the working memory task and correlated with cognitive metrics	Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Primary	Changes in working memory performance with neural stimulatoin	The working memory task will involve seeing a series of words presented on the screen and pressing a button to respond. Working memory task performance will be compared between stimulated and non stimulated blocks and between stimulation targets	Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Secondary	Change in beta power with neural stimulation	Beta power will be computed and compared between stimulation on and off conditions for different targets	Baseline to end of deep brain stimulation (DBS) surgery, approximately 3-4 hours