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NCT06820138 · ClinicalTrials.gov registry record · Phase 2
Focused Ultrasound for PTSD in Veterans
A Phase 2 study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT06820138: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.
NCT06820138 is a Phase 2 study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06820138, a Phase 2 study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The goal of this study is to develop a new, non-invasive brain stimulation modality called low intensity focused ultrasound (FUS) as a psychiatric rehabilitation treatment for posttraumatic stress disorder (PTSD). FUS delivers energy comparable to that involved in diagnostic ultrasound but in a millimeter-sized envelope. Unlike currently available methods, the maximal FUS energy is delivered at a distance from a transducer on the scalp. Therefore, its promise is that it can deliver focal and reversible modulation to deeper brain regions involved in PTSD. The investigator team has previously conducted first-in-human research in FUS, and this study builds upon that work to conduct a phase II, dose-finding study. This study will pursue two Aims; the first is whether FUS to the amygdala can improve symptoms, and the second will evaluate whether FUS improves function by reduced disability, over a 1-month period. Short and longer-term effects of FUS will be measured and all FUS parameters are within FDA-defined safety thresholds for diagnostic ultrasound.
Primary Outcome
The PTSD Checklist for Diagnostic and Statistical Manual-5 (PCL-5) is a gold standard self reported scale of PTSD symptoms. Scores range from 0-80, where higher scores indicate greater symptom severity. The Week 5 visit value is the primary outcome measure of the study.
Interventions
- DEVICE Brainsonix Ultrasound Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-08-03 |
| Est. Completion | 2030-03-29 |
| Phase | Phase 2 |
What is known before NCT06820138 opens enrollment
NCT06820138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Brainsonix Ultrasound Device is the first listed.
NCT06820138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06820138 about?
NCT06820138 is a clinical study titled "Focused Ultrasound for PTSD in Veterans". The goal of this study is to develop a new, non-invasive brain stimulation modality called low intensity focused ultrasound (FUS) as a psychiatric rehabilitation treatment for posttraumatic stress disorder (PTSD). FUS delivers energy comparable to that involved in diagnostic ultrasound but in a mill...
What is the current status of trial NCT06820138?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-08-03. Estimated completion is 2030-03-29.
What interventions are being tested in trial NCT06820138?
The interventions under investigation include: Brainsonix Ultrasound Device (DEVICE).
Who is sponsoring clinical trial NCT06820138?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06820138's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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