RecruitingPhase 4NCT06951906

Imaging Biomarkers of FOG Response to DBS

Imaging Biomarkers of Freezing of Gait Response to Deep Brain Stimulation


Sponsor

Medical University of South Carolina

Enrollment

54 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is using advanced brain imaging to understand why some people with Parkinson's disease experience "freezing of gait" (FOG) — a sudden inability to move the feet while walking — and whether deep brain stimulation (DBS) surgery can reduce this symptom. The goal is to identify brain imaging markers that predict how well DBS will help with FOG. **You may be eligible if...** - You are over 40 years old - You have been diagnosed with Parkinson's disease - You experience freezing of gait episodes and this has been confirmed by testing - You have been selected to undergo deep brain stimulation (DBS) surgery at MUSC **You may NOT be eligible if...** - You have significant walking difficulties caused by something other than Parkinson's (such as a joint problem) - You cannot complete walking tests on your own (without assistance or walking aids) - You cannot undergo an MRI scan (due to metal implants, pregnancy, or inability to lie still) - You will be receiving a type of DBS device that is not compatible with 3T MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTfMRI

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.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06951906


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