What this study is
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's being tested
- Brainsonix Ultrasound Device
Intervention · DEVICE
This device delivers low intensity focused ultrasound and delivers either active or sham sonication depending upon the transducer pad used.
Study details
- Official title
- Low Intensity Focused Ultrasound for Posttraumatic Stress Disorder
- Sponsor
- VA Office of Research and Development
- Conditions
- Posttraumatic Stress Disorder
- Enrolling
- 60 people
- Starts
- 2026-09-09
- Est. completion
- 2030-03-29
- Design
- Triple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openProvidence VA Medical Center, Providence, RI
Providence, Rhode Island, United States
- Kate J Barnabe, MHA · Contact(401) 273-7100 ext. 16272Kate.Barnabe@va.gov
- Amy Mochel · ContactAmy.Mochel@va.gov
- Noah S. Philip, MD · Principal investigator
Recruiting
Study team
Sponsor
VA Office of Research and Development
Study ID N5299-R
Principal investigator
Noah S. Philip, MD
Providence VA Medical Center, Providence, RI
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.