LIFU Mechanisms for PTSD in Healthcare Workers

NCT07164105 | Recruiting

• 1 other identifier: 20252812
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

PTSD and Trauma-related Symptoms

Outcome Measures

Primary Outcomes (2)

• LIFU target engagement

  Percent BOLD signal change in vACC and amygdala regions of interest

  Study day 1 to day 7 (plus or minus 3 days)

• Behavioral changes

  Change in reaction time (ms) and error rate (percentage of correct answers) on emotional conflict task; difference between optimal and observed flight initiation distance.

  Day 0 to Day 7 (plus or minus 3 days)

Secondary Outcomes (8)

• LIFU effects on physiology

  Day 0 to day 14 (plus or minus 6 days)

• LIFU effects on PTSD symptoms

  Dy 0 to day 14 (plus or minus 6)

• fMRI-heart rate variability correlation

  Day 0 to day 14 (plus or minus 6)

• fMRI-resting heart rate correlation

  Day 0 to day 14 (plus or minus 6)

• fMRI-REM sleep correlation

  Day 0 to day 14 (plus or minus 6)

Study Arms (2)

Low intensity focused ultrasound (LIFU)

EXPERIMENTAL

LIFU of the ventral anterior cingulate cortex

Device: Low intensity focused ultrasound

Sham

SHAM COMPARATOR

Sham neuromodulation (Sorbothane membrane over ultrasound probe)

Device: Sham modulation

Interventions

Sham modulation DEVICE

Low intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission

Sham

Low intensity focused ultrasound DEVICE

Low intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex

Also known as: LIFU

Low intensity focused ultrasound (LIFU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Adrienne Taren, MD, PhD

CONTACT

918-340-4116; ataren@laureateinstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 9, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)