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RecruitingNCT07164105

LIFU Mechanisms for PTSD in Healthcare Workers

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
66 (estimated)
Sponsor
Laureate Institute for Brain Research, Inc. · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICELow intensity focused ultrasoundLow intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex
DEVICESham modulationLow intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission

Timeline

Start date
2025-12-29
Primary completion
2028-08-01
Completion
2028-08-01
First posted
2025-09-09
Last updated
2026-03-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07164105. Inclusion in this directory is not an endorsement.