LIFU Mechanisms for PTSD in Healthcare Workers

Recruiting now · Not applicable · Has a placebo group

Conditions studied: PTSD and Trauma-related Symptoms

In brief

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

Key facts

Study ID

NCT07164105

Run by

Laureate Institute for Brain Research, Inc.

People needed

66

Starts

2025-12-29

Expected to finish

2028-08-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Laureate Institute for Brain Research — Tulsa, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

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