Status:
RECRUITING
LIFU Mechanisms for PTSD in Healthcare Workers
Lead Sponsor:
Laureate Institute for Brain Research, Inc.
Conditions:
PTSD and Trauma-related Symptoms
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- English proficiency as evaluated by language ability during screening
Exclusion
- 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
- 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.
- Non-correctable vision or hearing problems
- Unstable medical diagnoses
- Any structural abnormalities in the LIFU target region on screening brain MRI.
Key Trial Info
Start Date :
December 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT07164105
Start Date
December 29 2025
End Date
August 1 2028
Last Update
December 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136