RecruitingPhase 2NCT06820138

Focused Ultrasound for PTSD in Veterans

Low Intensity Focused Ultrasound for Posttraumatic Stress Disorder


Sponsor

VA Office of Research and Development

Enrollment

60 participants

Start Date

Sep 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Brainsonix Ultrasound Device for people with posttraumatic stress disorder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 22 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBrainsonix Ultrasound Device

This device delivers low intensity focused ultrasound and delivers either active or sham sonication depending upon the transducer pad used.


Locations(1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

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NCT06820138


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