The goal of this clinical trial is to learn about evaluate the safety, tolerability, and feasibility of MRI-guided LIFU targeting the sgACC in Veterans with post-traumatic brain injury depression. The main questions it aims to answer are: 1. the safety, tolerability, and feasibility of MRI-guided LIFU. 2. Evaluate preliminary antidepressant efficacy. 3. Characterize target engagement using multimodal neuroimaging and electrophysiology. 4. Identify imaging and electrophysiological biomarkers that predict treatment response. 5. Generate preliminary effect size estimates to support future multicenter clinical trials.
The study is a single-site, randomized (3:2 to active LIFU or sham), rater- and participant-blinded mechanistic study of MRI-guided low-intensity focused ultrasound (LI-FUS) targeting the subgenual anterior cingulate cortex (sgACC) in adult Veterans with post traumatic brain injury depression (PTD). The purpose of this study is to evaluate the safety and tolerability of repeated sgACC-targeted LI-FUS stimulation in adult Veterans with PTD. To evaluate the preliminary antidepressant efficacy of repeated sgACC-targeted LI-FUS in adult Veterans with PTD. To characterize the relationship between delivered LI-FUS dose and clinical response in adult Veterans with PTD. To characterize changes in neuroimaging and electrophysiologic measures associated with LI-FUS, including fMRI- and EEG-based indices of target engagement and network modulation, in adult Veterans with PTD. (b) To evaluate whether baseline fMRI and EEG features predict clinical response to LI-FUS in adult Veterans with PTD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
MRI-guided Low-Intensity Focused Ultrasound (LIFU) neuromodulation targeting the sgACC delivered over a brief, intensive course (20-minute sessions; 5 sessions/day for 5 consecutive days).
Non-active MRI-guided Low-Intensity Focused Ultrasound (LIFU) neuromodulation targeting the sgACC delivered over a brief, intensive course (20-minute sessions; 5 sessions/day for 5 consecutive days).
Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
Stanford, California, United States
To evaluate the safety and tolerability of repeated sgACC-targeted LIFU stimulation in adult Veterans with PTD.
Cumulative incidence of treatment-emergent adverse events and serious adverse events.
Time frame: Baseline, Treatment Days 1 through 5, 1-Week, 1-2:4-week follow up visits.
To evaluate the preliminary antidepressant efficacy of repeated sgACC-targeted LIFU in adult Veterans with PTD.
Absolute change from baseline in the MADRS total score.
Time frame: Baseline, 1-week follow up, 4-week follow up
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