RecruitingNCT06960096

Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study


Sponsor

Medical University of South Carolina

Enrollment

55 participants

Start Date

Aug 21, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of this research study is to understand how Deep Brain Stimulation (DBS) targeting the subthalamic nucleus (STN) affects cognitive networks in the brain, potentially leading to cognitive decline in patients with Parkinson's Disease (PD). A total of 55 participants with PD who have undergone DBS surgery will be recruited from MUSC's Clinical DBS Program. Participants will attend two post-DBS visits: a 3-hour visit for consent, demographic, and cognitive assessments, and a 3-hour DBS-MRI visit to evaluate brain network connectivity with stimulation ON and OFF. These findings will help improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how deep brain stimulation (DBS) surgery — a procedure that places a small device in the brain to help control movement — may affect memory and thinking in people with Parkinson's disease. Researchers will use brain scans (MRI) before and after the procedure to better understand these changes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with Parkinson's disease and have already been selected by your movement disorder team to undergo DBS surgery in the brain area called the STN - You have completed a neurological and thinking/memory assessment at the study center **You may NOT be eligible if...** - You have uncorrected vision or hearing problems - You are pregnant or plan to become pregnant during the study - You have another neurological condition (such as a prior stroke, epilepsy, or major head injury) besides Parkinson's - You have claustrophobia or cannot lie flat in an MRI scanner - You have severe lung disease requiring oxygen - You have metal implants or devices incompatible with MRI (such as a pacemaker) 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

OTHERDBS combined with fMRI

Participants will undergo fMRI scanning while their DBS device is either turned OFF or ON. BOLD (blood oxygen level dependent) changes in response to DBS will be evaluated across PD participants. These scans and DBS procedure will be used for research purposes only and are not for treatment or diagnostic purposes.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06960096


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