Cognitive Decline Following Deep Brain Stimulation

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05822388
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care — PROCEDURE
    Participants 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.

Study Details

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.

Key Dates

Start date
Apr 1, 2023
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Parkinson's Disease undergoing DBS
    This study will recruit 55 patients with Parkinson's disease (PD) participants who will undergo DBS surgery and and are scheduled for a pre-DBS neuropsychological evaluation at MUSC.
  • Arm: Healthy Control participants without Parkinson's Disease
    This study will recruit 25 healthy controls (age-matched) to serve as a comparison of baseline cognitive and neuroimaging measures.

Primary Outcome Measure

Change in Cognition [ Time Frame: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Daniel H Lench, PhD
[email protected]
843-792-9115

Find similar trials in Charleston, SC

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Medical University of South Carolina· Charleston, SC

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