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Focused Ultrasound for PTSD in Veterans

Low Intensity Focused Ultrasound for Posttraumatic Stress Disorder

Who can join

Ages 22 to 70 · All sexes

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

About the study

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.

What is being tested

• Brainsonix Ultrasound Device (device)

Sponsor: VA Office of Research and Development · Participants: 60 · Started: Sep 9, 2026

Contact the study team

• Noah S Philip, MD · Phone: (401) 273-7100
• Alison Gorbatov · Phone: (401) 271-7100

Official record on ClinicalTrials.gov — NCT06820138

Locations in the U.S.

Conditions

• Post-Traumatic Stress Disorder

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.