Imaging Biomarkers of FOG Response to DBS
This study is looking for 54 people with Parkinson's disease and Freezing of Gait (FOG) who are planning to have Deep Brain Stimulation (DBS) surgery. The goal is to understand how DBS affects FOG by looking at brain images and walking ability. Before DBS, you will have an MRI scan, walking tests, and other evaluations. After DBS, these assessments will be repeated over one year. The researchers want to see if changes in brain connections and activity, measured by MRI, are linked to how well DBS helps with FOG. The study is currently recruiting participants.
- Study design
- This is an interventional study planning to enroll 54 participants. The study does not specify a phase.
- What's involved
- You will complete 7 visits over approximately one year, including MRI scans, walking tests, and other evaluations before and after DBS surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your FOG response will be assessed at 12 months post-activation, and brain imaging will be analyzed in relation to DBS response at 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Imaging Biomarkers of FOG Response to DBS
At a glance
Conditions
NCT06951906
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Medical University of South Carolina
Charleston, South Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Turn DurationAssessed at Baseline (Visit 3) and at 12 months post-activation (Visit 7)
Turn duration is measured during the timed up and go (TUG) task. Subjects are instrumented with inertial measurement units (IMUs), and turn duration is measured from the first step onto a marked box to the last toe off the box during the turn.
- Difference in BOLD Response to STN-DBSAssessed post-operatively at 6 months (Visit 5) and 12 months (Visit 6).
Whole-brain activation is assessed via BOLD signal changes associated with T2\*-relaxation rate during combined Deep Brain Stimulation and functional MRI (DBS-fMRI). This involves cycling the DBS device ON and OFF during resting-state scans
- Difference in Structural ConnectivityBased on baseline diffusion MRI data (Visit 4) and analyzed in relation to DBS response determined at 12 months post-activation.
Structural connectivity profiles are determined using individual structural connectivity data and the Volume of Tissue Activated (VTA) model, which accounts for stimulation settings and lead placement. The outcome is the comparison of VTA connectivity to specific brain regions (e.g., GPi, SMA, M1, GPe) between STN-DBS responsive and unresponsive participants.
- Difference in Structural IntegrityBased on baseline diffusion MRI data (Visit 4) and analyzed in relation to DBS response determined at 12 months post-activation.
Microstructural integrity of brain structures (e.g., STN, GPi, PPN) is assessed using advanced diffusion MRI metrics, specifically Diffusional Kurtosis Imaging (DKI). The outcome is the comparison of these metrics between STN-DBS responsive and unresponsive participants.