Development of Low-Intensity Focused Ultrasound for Post Traumatic Brain Injury Depression

Conditions

• Post-traumatic Brain Injury Depression
• Veteran Health

Eligibility Criteria

Sex

ALL

Age

22 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Active Low-Intensity Focused Ultrasound (LIFU) — DEVICE
  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).
• Sham Low-Intensity Focused Ultrasound (LIFU) — OTHER
  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).

Study Details

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.

Key Dates

First listed

Sep 18, 2026

Start date

Nov 1, 2026

Status verified

Sep 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

25 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Active Low-Intensity Focused Ultrasound (LIFU)
  Participants receive active LIFU over 5 consecutive treatment days, with 5 sessions per day and 20 minutes per session
• Sham Comparator: Sham Low-Intensity Focused Ultrasound (LIFU)
  Participants receive sham LIFU over 5 consecutive treatment days, with 5 sessions per day and 20 minutes per session

Primary Outcome Measure

To evaluate the safety and tolerability of repeated sgACC-targeted LIFU stimulation in adult Veterans with PTD. [ Time Frame: Baseline, Treatment Days 1 through 5, 1-Week, 1-2:4-week follow up visits. ]

Central Contacts

• Masataka Wada, MD
  650-434-7844
  [email protected]
• John P Coetzee, PhD
  [email protected]

Locations (1)

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