Imaging Biomarkers of FOG Response to DBS (NCT06951906) | Clinical Trial Compass
RecruitingPhase 4
Imaging Biomarkers of FOG Response to DBS
United States54 participantsStarted 2024-11-11
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. \>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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Turn Duration
Timeframe: Assessed at Baseline (Visit 3) and at 12 months post-activation (Visit 7)
2
Difference in BOLD Response to STN-DBS
Timeframe: Assessed post-operatively at 6 months (Visit 5) and 12 months (Visit 6).
3
Difference in Structural Connectivity
Timeframe: Based on baseline diffusion MRI data (Visit 4) and analyzed in relation to DBS response determined at 12 months post-activation.
4
Difference in Structural Integrity
Timeframe: Based on baseline diffusion MRI data (Visit 4) and analyzed in relation to DBS response determined at 12 months post-activation.