RecruitingNCT05822388

Cognitive Decline Following Deep Brain Stimulation

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation

Sponsor

Medical University of South Carolina

Enrollment

80 participants

Start Date

Apr 1, 2023

Study Type

OBSERVATIONAL

Conditions

Movement Disorders Parkinson Disease

Summary

This research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo four visits, including a 1-hour screening visit, a 1.5-hour pre-DBS MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study follows people with Parkinson's disease who are having deep brain stimulation (DBS) surgery — where electrodes are placed in the brain to improve movement — to see how the procedure affects thinking and memory over time. Some people with Parkinson's notice cognitive changes after DBS, and this study aims to better understand who is most at risk and why. **You may be eligible if...** - You have Parkinson's disease - You are scheduled to have DBS surgery as part of your regular clinical care - You are 18 or older - OR you are a person without Parkinson's willing to serve as a healthy comparison participant **You may NOT be eligible if...** - You have uncorrected vision or hearing problems - You are pregnant or planning to become pregnant during the study - You have claustrophobia or cannot lie still in an MRI scanner - You have non-MRI-compatible metal implants (pacemakers, certain clips) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDeep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care

Participants in this study will already be undergoing a DBS intervention, however, this is part of their standard clinical care. Pre-surgical DBS candidates that enroll in this study will consent to participate in 1) pre-operative neuroimaging including a high-resolution MRI scan, 2) collection of pre-operative neurocognitive data via chart review and 3) a 1-year postoperative neurocognitive assessment.

Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT05822388

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