Focused Ultrasound for PTSD in Veterans

NCT06820138 | Not Yet Recruiting Phase 2 DMC FDA Device

• 1 other identifier: N5299-R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Low intensity focused ultrasound

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist for DSM5

  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.

  Up to 3 months

Secondary Outcomes (5)

• Sheehan Disability Scale

  Up to 3 months

• Social and Occupational Function Scale

  Up to 3 months

• Inventory of Depressive Symptoms Self Report

  Up to 3 months

• Clinician Administered PTSD Scale

  Up to 3 months

• Clinician Global Impression

  Up to 3 months

Other Outcomes (2)

• Visual Analog Scale

  Three times per week for up to five weeks

• Arterial Spin Labeling/fMRI

  Five weeks

Study Arms (2)

Verum low intensity focused ultrasound

ACTIVE COMPARATOR

Verum (active) low intensity focused ultrasound, applied up to three times per week.

Device: Brainsonix Ultrasound Device

Sham low intensity focused ultrasound

SHAM COMPARATOR

Sham (inactive) low intensity focused ultrasound, applied up to three times per week.

Device: Brainsonix Ultrasound Device

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.

Also known as: Brainsonix Pulsar

Sham low intensity focused ultrasound; Verum low intensity focused ultrasound

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans ages 22-70 (inclusive) who meet DSM-5 criteria for chronic 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 may not qualify 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Noah S. Philip, MD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah S Philip, MD

CONTACT

(401) 273-7100; noah.philip@va.gov

Alison Gorbatov

CONTACT

(401) 271-7100; Alison.Gorbatov@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical active and sham transducer pads are used; these are pads used to couple the ultrasound device to the participant. Sham pads have material that does not permit ultrasound energy to pass through
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 11, 2025
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 29, 2030
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)