LIFU Mechanisms for PTSD in Healthcare Workers

Part of paid clinical trials in Tulsa, Oklahoma.

Sponsor
Laureate Institute for Brain Research, Inc.
Study ID
NCT07164105
Status
Recruiting
Apply to this trial

Conditions

  • PTSD and Trauma-related Symptoms

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Low intensity focused ultrasound — DEVICE
    Low intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex
  • Sham modulation — DEVICE
    Low intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission

Study Details

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 Dates

Start date
Dec 29, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Low intensity focused ultrasound (LIFU)
    LIFU of the ventral anterior cingulate cortex
  • Sham Comparator: Sham
    Sham neuromodulation (Sorbothane membrane over ultrasound probe)

Primary Outcome Measure

LIFU target engagement [ Time Frame: Study day 1 to day 7 (plus or minus 3 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Laureate Institute for Brain ResearchTulsaOklahoma74136
Adrienne Taren, MD, PhD
[email protected]
918-340-4116
Courtney Kilpatrick
[email protected]
Adrienne Taren, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tulsa, OK

By research site
Laureate Institute for Brain Research· Tulsa, OK

Related Studies