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Focused Ultrasound for PTSD in Veterans

RecruitingPhase 2Ages 22 Years - 70 YearsAllVA Office of Research and Development
NCT06820138 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, ov

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📋 Eligibility rules (as published)
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
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What it tests

  • Brainsonix Ultrasound Device
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Where

1 site
Providence VA Medical Center, Providence, RI
Providence, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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