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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06960096
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • DBS combined with fMRI — OTHER
    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.

Study Details

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.

Key Dates

Start date
Aug 21, 2025
Status verified
Oct 2025
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
55 participants (estimated)

Arms

  • Arm: Patients with Parkinson's Disease undergoing DBS

Primary Outcome Measure

Change in executive function performance [ Time Frame: Baseline and approximately 1 year (10-14 months) following deep brain stimulation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Daniel H. Lench, Phd
[email protected]
843-792-9115

Find similar trials in Charleston, SC

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Medical University of South Carolina· Charleston, SC

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