RECRUITING Phase 2 ClinicalTrials.gov

Focused Ultrasound for PTSD in Veterans

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT06820138

Registry updated: 2026-09-15

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Description

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.

Interventions

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

Eligibility criteria

Inclusion Criteria: -Veterans ages who meet DSM-5 criteria for chronic Post-traumatic stress disorder (PTSD) using the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and currently symptomatic. If applicable, Veterans will be required to be on stable psychiatric treatment(s) prior to baseline assessments Exclusion Criteria: * contraindications to focused ultrasound and/or neuroimaging: * i) history of seizure disorder or serious neurologic illness including dementia or serious cognitive impairment, * ii) structural or neurologic abnormalities present or in close proximity to sonication site * iii) prior brain surgery * iv) pacemaker or implanted central nervous system device * v) greater than mild traumatic brain injury, or any head injury within sixty days of ultrasound * vi) greater than moderate alcohol or substance use disorders or active use or withdrawal from alcohol or substances * vii) metal in the head * viii) physical impediment likely to interfere with assessments, or * ix) unable to follow protocols * x) Veterans with significant white matter findings or those with findings in the beam of the ultrasound may also be excluded at discretion of study staff * Veterans with acute suicidality are also excluded

Conditions

Posttraumatic Stress Disorder

Locations

Providence VA Medical Center, Providence, RI — Providence, Rhode Island, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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