Status:
RECRUITING
Imaging Biomarkers of FOG Response to DBS
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Freezing of Gait Symptoms in Parkinson's Disease
Deep Brain Stimulation
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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 stud...
Detailed Description
The long-term goal of this research is to develop an individualized approach for the treatment of Freezing of Gait (FOG) with Deep Brain Stimulation (DBS). In pursuit of this goal, the investigators h...
Eligibility Criteria
Inclusion
- \>40 years of age.
- diagnosis of PD based on UK Brain Bank diagnostic criteria.
- presence of FOG, defined as a score of 1 on part 1 of the nFOGQ and confirmed by objective evaluation (a score of 1 represents a positive response of having experienced such an episode over the last month).
- clinically selected at the MUSC DBS Conference to undergo STN-DBS surgery.
Exclusion
- a history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities).
- inability to complete gait assessments (timed-up-and-go task) in the OFF state without assistance or assist devices.
- contraindications to MRI, including inability to lie supine in the scanner environment, pregnancy, and non-MRI compatible metal implants.
- implantation of non-3 T MRI-compatible DBS devices.
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06951906
Start Date
November 11 2024
End Date
January 1 2030
Last Update
August 6 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425