NCT06960096 Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study
| NCT ID | NCT06960096 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Deep Brain Stimulation |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2025-08-21 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2025-08-21 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.)
Contact & Investigator
Daniel Lench, PhD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06960096 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Deep Brain Stimulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06960096 currently recruiting?
Yes, NCT06960096 is actively recruiting participants. Contact the research team at malakout@musc.edu for enrollment information.
Where is the NCT06960096 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06960096 clinical trial?
NCT06960096 is sponsored by Medical University of South Carolina. The principal investigator is Daniel Lench, PhD at Medical University of South Carolina. The trial plans to enroll 55 participants.