How deep brain stimulation affects thinking and memory in Parkinson's
A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study
Medical University of South Carolina · NCT06960096
This project will use MRI scans to see if subthalamic nucleus deep brain stimulation (DBS) changes brain networks and relates to thinking or memory declines in people with Parkinson's disease who already have DBS implants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06960096 on ClinicalTrials.gov |
What this trial studies
Researchers will recruit 55 people with Parkinson's disease who have undergone 3T‑compatible unilateral or bilateral STN‑DBS at the Medical University of South Carolina. Participants will complete one visit for consent, demographic and cognitive testing and a second visit with DBS‑compatible MRI scanning while stimulation is turned ON and OFF to measure brain network connectivity. The team will compare functional connectivity and microstructural features to participants' cognitive performance to identify patterns linked to post‑DBS cognitive decline. The goal is to use these findings to refine which patients and stimulation targets are least likely to cause unwanted cognitive side effects.
Who should consider this trial
Good fit: Adults with Parkinson's disease who previously received 3T‑compatible unilateral or bilateral STN‑DBS implants and completed a neurological and neuropsychological evaluation at MUSC are ideal candidates.
Not a fit: People without STN‑DBS, with non‑MRI‑compatible implants, severe claustrophobia, significant non‑PD neurological disease, or those who cannot safely undergo MRI are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help doctors choose patients and stimulation targets that lower the risk of cognitive decline after STN‑DBS.
How similar studies have performed: Prior work has shown that DBS can alter cognitive performance and functional connectivity and that fMRI can detect network changes, but using ON/OFF DBS‑fMRI to directly link those changes to long‑term cognitive decline is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects above 18 years of age * Individuals with a PD diagnosis as defined by the UK Brain Bank diagnostic criteria for Parkinson's disease (58) which have undergone a neurological and neuropsychological evaluation at MUSCs movement disorder center, and were selected to undergo 3T compatible unilateral or bilateral STN- DBS implants Exclusion Criteria: * Uncorrected visual or hearing impairments, as indicated by self-report * Individuals who are pregnant or expect to become pregnant during the course of the study * Individuals that have a history of neurological disease (other than PD) including previous stroke, major head trauma, and epilepsy or seizures. * Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner * COPD with oxygen dependence * Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel Lench, PhD — Medical University of South Carolina
- Study coordinator: Recruitment Coordinator
- Email: malakout@musc.edu
- Phone: 843-792-0235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Deep Brain Stimulation, Parkinson Disease, Brain, Parkinsons, deep brain stimulation, Cognitive