Actively Recruiting
A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study
Led by Medical University of South Carolina · Updated on 2025-10-14
55
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how Deep Brain Stimulation (DBS) targeting the subthalamic nucleus (STN) affects brain networks related to thinking and memory in people with Parkinson's Disease (PD). The study aims to understand why some patients experience cognitive decline after DBS surgery despite careful evaluation before the procedure. This research explores how changes in brain connectivity and structure caused by DBS might lead to these declines and hopes to improve patient selection and stimulation targeting to reduce unwanted cognitive effects. Participants in this observational study have all undergone DBS surgery for PD. They will attend two study visits after their surgery: one 3-hour visit for consent, demographic information, and cognitive testing, and another 3-hour visit involving MRI scans while their DBS device is switched ON and OFF. The scans will measure brain activity and network changes caused by DBS using functional MRI techniques. During the study, researchers will assess changes in executive function, language, and attention over about one year after DBS implantation. Participants will undergo cognitive tests and brain imaging to evaluate these changes. The study will monitor how brain stimulation impacts cognitive networks and will follow participants for about 10 to 14 months to understand the long-term effects. This information will help refine DBS treatment strategies for Parkinson's Disease.
CONDITIONS
Brief Title
Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with Parkinson's Disease according to UK Brain Bank criteria
- Have undergone neurological and neuropsychological evaluation at MUSC's movement disorder center
- Have received a 3T-compatible unilateral or bilateral STN-DBS implant
You will not qualify if you...
- Uncorrected visual or hearing impairments
- Pregnant or expecting to become pregnant during the study
- History of neurological diseases other than Parkinson's Disease, including stroke, major head trauma, epilepsy, or seizures
- Claustrophobia or inability to lie still in an MRI scanner
- COPD requiring oxygen
- Presence of non-MRI compatible metal implants such as surgical clips, staples, or pacemakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and approximately 1 year (10-14 months) following deep brain stimulation
Participants undergo fMRI scanning while their DBS device is either turned OFF or ON to evaluate brain activity related to deep brain stimulation.
2 visits (in-person) at baseline and follow-up
Duration - Approximately 1 year (10-14 months)
Participants are observed to assess changes in executive function, language, and attention following DBS implantation over approximately one year.
2 visits (in-person) at baseline and follow-up
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
R
Recruitment Coordinator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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