Low-intensity focused ultrasound targeting the ventral anterior cingulate for PTSD in frontline healthcare workers
Official title: Mechanisms of Low Intensity Focused Ultrasound of the Ventral Anterior Cingulate Cortex for Post-Traumatic Stress Disorder in Frontline Healthcare Workers
Run by Laureate Institute for Brain Research, Inc. · NCT07164105 · Data updated 2026-11-12
This trial tests whether a single session of low-intensity focused ultrasound (LIFU) to a brain region called the ventral anterior cingulate can change brain activity and reduce PTSD symptoms in frontline healthcare workers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Laureate Institute for Brain Research, Inc. Academic / other |
| Locations | 1 site (Tulsa, Oklahoma) |
| Status | Recruiting |
| Started | December 29, 2025 |
| Main results expected | August 2028 |
| Study ends | August 2028 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT07164105 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Frontline healthcare workers aged 18–65 with a PCL-5 score ≥33 (or partial PTSD on the MINI), fluent in English, and able to undergo MRI and LIFU procedures are ideal candidates.
✕Probably not a fit
Individuals with neurological disorders, psychotic disorders, recent moderate-to-severe substance use, bipolar disorder, recent suicide risk or attempt, severe traumatic brain injury, skull fractures, or other listed exclusions are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This double-blind, randomized, sham-controlled trial enrolls 66 frontline healthcare workers aged 18–65 with clinically significant PTSD symptoms. Participants complete baseline structural and functional MRI, two task-based scans, and begin continuous wearable monitoring plus daily symptom surveys. Subjects are randomized to a single session of active or sham LIFU targeting the ventral anterior cingulate cortex, with identical MRI and questionnaire batteries repeated immediately before and after the intervention. The study compares changes in vACC–amygdala activity and connectivity, threat sensitivity, emotion regulation, sleep, and physiological metrics to determine acute neural and behavioral effects.
Why it matters
Potential benefit: If successful, this approach could offer a noninvasive way to normalize fronto-limbic brain circuitry and reduce PTSD symptoms in frontline healthcare workers.
How similar studies have gone: Low-intensity transcranial ultrasound is an emerging neuromodulation method with promising early human and preclinical data for modulating brain circuits, but clinical evidence specifically for PTSD remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults in a frontline healthcare position (e.g. emergency medical services) 2. Ages 18-65 years 3. PTSD Checklist for DSM-5 (PCL-5) score ≥ 33 and \< 65, OR at least partial PTSD as measured by the MINI 4. English proficiency as evaluated by language ability during screening Exclusion Criteria: 1. Neurological disorders 2. 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 3. 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. 4. History of severe traumatic brain injury (as indicated by score ≥ 3 on the Tulsa Head Injury Screen) or of skull fractures 5. Contraindications to MRI as determined by the MR Environment Screening 6. Pregnancy, determined by urine pregnancy test administered prior to every MRI scanning procedure 7. Evidence of inability to comply with study procedures based on experimenter judgement. 8. 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. 9. Non-correctable vision or hearing problems 10. Unstable medical diagnoses 11. Any structural abnormalities in the LIFU target region on screening brain MRI.
Where it's running
-
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States Recruiting
Study contacts
- Study coordinator: Adrienne Taren, MD, PhD
- Email: ataren@laureateinstitute.org
- Phone: 918-340-4116
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.