Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- DBS combined with fMRI
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Medical University of South Carolina
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov