LIFU Mechanisms for PTSD in Healthcare Workers

Not Applicable

Not yet recruiting

• Conditions: PTSD and Trauma-related Symptoms

• Registration Number: NCT07164105
• Lead Sponsor: Laureate Institute for Brain Research, Inc.

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 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-22
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-02
• Study First Posted: 2025-09-09
• Last Update Submitted: 2025-09-24
• Last Update Posted: 2025-09-29
• Study Start: 2025-10-15
• Primary Completion: 2028-08
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
LIFU target engagement	Study day 1 to day 7 (plus or minus 3 days)	Percent BOLD signal change in vACC and amygdala regions of interest
Behavioral changes	Day 0 to Day 7 (plus or minus 3 days)	Change in reaction time (ms) and error rate (percentage of correct answers) on emotional conflict task; difference between optimal and observed flight initiation distance.

Secondary Outcome Measures

Name	Time	Method
fMRI-heart rate variability correlation	Day 0 to day 14 (plus or minus 6)	Correlations between vACC/amygdala BOLD signal extracted beta-weights and heart rate variability (ms) as measured by WHOOP® band.
fMRI-deep sleep correlation	Day 0 to day 14 (plus or minus 6)	Correlations between vACC/amygdala BOLD signal extracted beta-weights and %deep sleep (minutes) as measured by WHOOP® band
fMRI-PTSD Symptom Correlation	Day 0 to day 14 (plus or minus 6)	Correlations between vACC/amygdala BOLD signal extracted beta-weights and PCL-5 score.
fMRI-Emotion Regulation Correlation	Day 0 to day 14 (plus or minus 6)	Correlations between vACC/amygdala BOLD signal extracted beta-weights and Cognitive-Emotion Regulation Questionnaire Score.
LIFU effects on physiology	Day 0 to day 14 (plus or minus 6 days)	Change in heart rate variability (ms), change in resting heart rate (beats per minute), change in %REM sleep (minutes), change in %deep sleep (minutes) as measured by WHOOP® band
LIFU effects on PTSD symptoms	Dy 0 to day 14 (plus or minus 6)	Change in PCL-5 score
fMRI-resting heart rate correlation	Day 0 to day 14 (plus or minus 6)	Correlations between vACC/amygdala BOLD signal extracted beta-weights and resting heart rate (beats per minute) as measured by WHOOP® band.
fMRI-REM sleep correlation	Day 0 to day 14 (plus or minus 6)	Correlations between vACC/amygdala BOLD signal extracted beta-weights and %REM sleep (minutes) as measured by WHOOP® band.

Trial Locations

Locations (1)

Laureate Institute for Brain Research; 🇺🇸 Tulsa, Oklahoma, United States