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
This trial accepts healthy volunteersQualifiers
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 population
This study will enroll individuals with Parkinson's disease who are undergoing clinically indicated subthalamic nucleus deep brain stimulation (STN-DBS). Participants will complete pre-operative neuroimaging using diffusion and structural MRI sequences, as well as standardized neurocognitive assessments. One year following DBS, participants will complete a follow-up cognitive evaluation. The goal is to identify brain microstructural features that predict cognitive decline after DBS.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
DBS combined with fMRI
Other interventionParticipants 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.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Patients with Parkinson's Disease undergoing DBS1 intervention
Trial outcomes
Primary outcomes
1
Change in executive function performance
Cognitive domains known to be affected by subthalamic deep brain stimulation (STN-DBS) will be evaluated using a standardized neuropsycholoical battery. A composite measure of tests within the executive function domain (task-switching, verbal fluency, and inhibitory control) will be assessed as the primary outcome measure for behavior.
Time frame
Baseline and approximately 1 year (10-14 months) following deep brain stimulationSecondary outcomes
1
Change in Language and Attention
Cognitive domains known to be affected by subthalamic deep brain stimulation (STN-DBS) will be evaluated using a standardized neuropsycholoical battery. A composite measure of tests within the language and attention domains will be assessed as secondary outcome measure for behavior.
Time frame
Baseline and approximately 1 year (10-14 months) following deep brain stimulationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov