Focused ultrasound to help veterans with PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, dose-finding study testing low intensity focused ultrasound (FUS) delivered to the amygdala for PTSD in veterans. The trial aims to determine whether FUS can improve symptom severity and functional disability over one month, with attention to safety and short- and longer-term effects. Participants are Veterans with chronic PTSD who are stable on psychiatric treatment if applicable. The intervention uses a Brainsonix ultrasound device to target deep brain regions non-invasively, contrasting with high-intensity approaches that cause tissue ablation. Eligibility excludes individuals with certain neurologic conditions, recent brain injury, active substance use issues, metal in the head, or implants that contraindicate ultrasound or neuroimaging.

Why it matters

Who can join: the full rules

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

Where it's running

• Providence VA Medical Center, Providence, RI
  Providence, Rhode Island, United States Recruiting

Study contacts

• Principal investigator: Noah S. Philip, MD — Providence VA Medical Center, Providence, RI
• Study coordinator: Noah S Philip, MD
• Email: noah.philip@va.gov
• Phone: (401) 273-7100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.