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Imaging Biomarkers of FOG Response to DBS

NCT06951906 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-08-06

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

fMRI

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2029-11-30
Completion
2030-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06951906 on ClinicalTrials.gov