Mechanisms of Low Intensity Focused Ultrasound of the Ventral Anterior Cingulate Cortex for Post-Traumatic Stress Disorder in Frontline Healthcare Workers

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Oklahoma
Laureate Institute for Brain Research
RECRUITING
Tulsa
Contact Information
Primary
Adrienne Taren, MD, PhD
ataren@laureateinstitute.org
918-340-4116
Time Frame
Start Date: 2025-12-29
Estimated Completion Date: 2028-08
Participants
Target number of participants: 66
Treatments
Experimental: Low intensity focused ultrasound (LIFU)
LIFU of the ventral anterior cingulate cortex
Sham_comparator: Sham
Sham neuromodulation (Sorbothane membrane over ultrasound probe)
Related Therapeutic Areas
Sponsors
Leads: Laureate Institute for Brain Research, Inc.

This content was sourced from clinicaltrials.gov