Focused Ultrasound for PTSD in Veterans

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
VA Office of Research and Development
Study ID
NCT06820138
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Feb 11, 2025
Start date
Sep 9, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2029
Completion
Mar 29, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Verum low intensity focused ultrasound
    Verum (active) low intensity focused ultrasound, applied up to three times per week.
  • Sham Comparator: Sham low intensity focused ultrasound
    Sham (inactive) low intensity focused ultrasound, applied up to three times per week.

Primary Outcome Measure

Post-traumatic stress disorder (PTSD) Checklist for DSM5 [ Time Frame: Up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Providence VA Medical Center, Providence, RIProvidenceRhode Island02908-4734
Kate J Barnabe, MHA
[email protected]
(401) 273-7100
Amy Mochel
[email protected]
Noah S. Philip, MD (PRINCIPAL_INVESTIGATOR)

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PTSD (post-traumatic stress disorder)
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By research site
Providence VA Medical Center, Providence, RI· Providence, RI

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