Imaging Biomarkers of FOG Response to DBS

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06951906
Phase
PHASE4
Status
Recruiting
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Conditions

  • Deep Brain Stimulation
  • Freezing of Gait Symptoms in Parkinson's Disease

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • fMRI — DIAGNOSTIC_TEST
    Baseline imaging will utilize advanced diffusion MRI metrics to determine which brain areas are structurally connected to the stimulation target and their structural integrity. Post-operative assessments will include behavioral measures of FOG response and imaging measures of neural response to stimulation. Pre- and post-operative data will be used to evaluate the association between structural integrity, connectivity and behavioral response.

Study Details

For this study, the investigators are recruiting 54 individuals with Parkinson's Disease and Freezing of Gait (FOG) who are planning to undergo Deep Brain Stimulation (DBS). The objective of this study is to better understand the FOG response to DBS. Prior to DBS, participants will undergo an MRI scan, behavioral assessment related to walking, a cognitive evaluation, and assessment of other Parkinson's disease symptoms. Following DBS, participants will repeat these assessments at multiple timepoints over the period of one year. Overall, participants will complete a total of 7 visits over a period of approximately 1 year.

Key Dates

Start date
Nov 11, 2024
Status verified
Aug 2025
Primary completion
Nov 30, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: PD Patients with FOG undergoing DBS

Primary Outcome Measure

Turn Duration [ Time Frame: Assessed at Baseline (Visit 3) and at 12 months post-activation (Visit 7) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Niloufar Malakouti, M.D.
[email protected]
843-792-0235
Mahdi Sowlat, M.D.
[email protected]
8438766410
Gonzalo J. Revuelta, MS, DO, FANA (PRINCIPAL_INVESTIGATOR)

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By research site
Medical University of South Carolina· Charleston, SC

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