Cognitive Decline Following Deep Brain Stimulation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
This research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo four visits, including a 1-hour screening visit, a 1.5-hour pre-DBS MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects above 18 years of age
Subjects who will undergo DBS surgery as part of their clinical care for PD
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 with claustrophobia, or the inability to lie supine position in the MRI scanner
COPD with oxygen dependence
Trial population
Patients with Parkinson's disease (PD) participants who will undergo DBS surgery and healthy controls.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care
Procedure/SurgeryParticipants in this study will already be undergoing a DBS intervention, however, this is part of their standard clinical care. Pre-surgical DBS candidates that enroll in this study will consent to participate in 1) pre-operative neuroimaging including a high-resolution MRI scan, 2) collection of pre-operative neurocognitive data via chart review and 3) a 1-year postoperative neurocognitive assessment.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Parkinson's Disease undergoing DBS1 intervention
Group B: Healthy Control participants without Parkinson's Disease0 interventions
Trial outcomes
Primary outcomes
1
Change in Cognition
Change in cognitive performance using a comprehensive neuropsychological battery (e.g., language, executive control, memory, and attention)
Time frame
From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery2
Brain Microstructure (DKI)
Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion kurtosis imaging (mean kurtosis; MK)
Time frame
Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))Secondary outcomes
1
Brain Functional Connectivity
Functional connectivity in cognitive networks including the Nucleus Basalis of Meynert (NBM) and the striatum
Time frame
Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))2
Brain Microstructure (DTI)
Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion tensor imaging (mean diffusivity; MD)
Time frame
Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))Sponsors and contacts
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Source ClinicalTrials.gov