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NOT YET RECRUITING
NCT06820138
PHASE2

Focused Ultrasound for PTSD in Veterans

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Low Intensity Focused Ultrasound for Posttraumatic Stress Disorder

Key Details

Gender

All

Age Range

22 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-08-03

Completion Date

2030-03-29

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DEVICE

Brainsonix 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