Understanding how Deep Brain Stimulation affects Freezing of Gait in Parkinson's Disease
Imaging Biomarkers of Freezing of Gait Response to Deep Brain Stimulation
This study is testing how Deep Brain Stimulation can help people with Parkinson's Disease who struggle with Freezing of Gait by looking at their brain and behavior before and after the treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06951906 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit 54 individuals with Parkinson's Disease who experience Freezing of Gait (FOG) and are scheduled for Deep Brain Stimulation (DBS). Participants will undergo a series of assessments, including MRI scans and behavioral evaluations, both before and after the DBS procedure over the course of one year. The goal is to develop a personalized treatment approach for FOG by examining the relationship between brain structure, stimulation parameters, and patient responses. This research will help clarify how DBS can be optimized for individuals suffering from FOG.
Who should consider this trial
Good fit: Ideal candidates are individuals over 40 years old with a confirmed diagnosis of Parkinson's Disease and experiencing Freezing of Gait.
Not a fit: Patients with significant gait impairments unrelated to Parkinson's Disease or those unable to undergo MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatments for patients with Freezing of Gait in Parkinson's Disease.
How similar studies have performed: While there have been studies on DBS for Parkinson's Disease, this specific approach focusing on FOG response and imaging biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. \>40 years of age. 2. diagnosis of PD based on UK Brain Bank diagnostic criteria. 3. 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). 4. clinically selected at the MUSC DBS Conference to undergo STN-DBS surgery. Exclusion Criteria: 1. a history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities). 2. inability to complete gait assessments (timed-up-and-go task) in the OFF state without assistance or assist devices. 3. contraindications to MRI, including inability to lie supine in the scanner environment, pregnancy, and non-MRI compatible metal implants. 4. implantation of non-3 T MRI-compatible DBS devices.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.