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Focused Ultrasound for PTSD in Veterans

Study acronym: PTSD FUS
StatusRecruiting
PhasePhase 2
Started2026-09-09
View on ClinicalTrials.gov ↗
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.

Amendment history 3 changes detected by DataLookout

2026-09-16
notable
Recruitment opened
2026-09-16
minor
Trial started: 2026-09-09 (last estimated 2026-09-08)
2026-09-09
critical
Primary endpoint(s) modified
WasPTSD Checklist for DSM5
NowPost-traumatic stress disorder (PTSD) Checklist for DSM5
Trial Details
NCT Number NCT06820138
Lead Sponsor VA Office of Research and Development
Conditions Posttraumatic Stress Disorder
Enrollment 60 participants
Start Date 2026-09-09
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-03-29 (estimated)
Updated on ClinicalTrials.gov 2026-09-15