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Studies

Interventional Recruiting Phase 2

NCT06820138 on ClinicalTrials.gov

Focused Ultrasound for PTSD in Veterans

Official title: Low Intensity Focused Ultrasound for Posttraumatic Stress Disorder

  • Sponsor: VA Office of Research and Development
  • Enrollment: 60 (Estimated)
  • Study start: 2026-09-09 (Actual)
  • Primary completion: 2029-12-31 (Estimated)
  • Study completion: 2030-03-29 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Double-blind delivery of low intensity focused ultrasound (i.e., active low intensity focused ultrasound versus a sham (placebo) administration of low intensity focused ultrasound). Sessions are approximately three times a week for four weeks.
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Posttraumatic Stress Disorder

Intervention / Treatment

  • Device: Brainsonix Ultrasound Device

Primary Outcome Measures

  • Post-traumatic stress disorder (PTSD) Checklist for DSM5 (Up to 3 months)
    The PTSD Checklist for Diagnostic and Statistical Manual-5 (PCL-5) is a gold standard self reported scale of PTSD symptoms. Scores range from 0-80, where higher scores indicate greater symptom severity. The Week 5 visit value is the primary outcome measure of the study.

Countries

United States

Locations and Investigators

  • Providence VA Medical Center, Providence, RI, Providence, United States (Recruiting)

Study Officials