LIFU Mechanisms for PTSD in Healthcare Workers (NCT07164105) | Clinical Trial Compass
RecruitingNot Applicable
LIFU Mechanisms for PTSD in Healthcare Workers
United States66 participantsStarted 2025-12-29
Plain-language summary
The goal of this clinical trial is to evaluate whether low-intensity focused ultrasound (LIFU) of the ventral anterior cingulate cortex (vACC) can normalize dysfunctional brain activation patterns and behaviors in frontline healthcare workers with post-traumatic stress disorder. The main questions it aims to answer are:
* Does LIFU of the vACC effect activity and connectivity of the vACC and amygdala?
* Does LIFU of the vACC reduce post-traumatic stress symptoms? Researchers will compare LIFU to sham modulation to see if LIFU modulates activity of vACC-amygdala circuitry and affects threat sensitivity and emotion regulation.
Participants will:
* Complete two fMRI sessions (before and after LIFU)
* Receive a single session of LIFU or sham modulation of the vACC
* Wear a wearable device that tracks sleep and heart rate metrics
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Adults in a frontline healthcare position (e.g. emergency medical services)
✓. Ages 18-65 years
✓. PTSD Checklist for DSM-5 (PCL-5) score ≥ 33 and \< 65, OR at least partial PTSD as measured by the MINI
✓. English proficiency as evaluated by language ability during screening
Exclusion criteria
✕. Neurological disorders
✕. DSM-5 diagnosis of psychotic disorders, eating disorder, obsessive-compulsive disorder, moderate to severe alcohol or substance use disorder within the past year, bipolar disorder, or major depressive disorder with psychosis
✕. Suicidal intent or plan (as measured by Suicide-Risk-Assessment-C-SSRS "Yes" answers to items 3, 4 or 5 of Suicidal Ideation-Past 1 month section, or any "Yes" answer to any of the items of Suicidal Behavior-Past 3 months section), or any suicide attempt in the last 3 months.
✕. History of severe traumatic brain injury (as indicated by score ≥ 3 on the Tulsa Head Injury Screen) or of skull fractures
What they're measuring
1
LIFU target engagement
Timeframe: Study day 1 to day 7 (plus or minus 3 days)
2
Behavioral changes
Timeframe: Day 0 to Day 7 (plus or minus 3 days)
Trial details
NCT IDNCT07164105
SponsorLaureate Institute for Brain Research, Inc.
✕. Contraindications to MRI as determined by the MR Environment Screening
✕. Pregnancy, determined by urine pregnancy test administered prior to every MRI scanning procedure
✕. Evidence of inability to comply with study procedures based on experimenter judgement.
✕. Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning, e.g., anxiolytics, antipsychotics, antidepressants, benzodiazepines, or mood stabilizers.