Recruiting

LIFU

Sponsor:

Laureate Institute for Brain Research, Inc.

Code:

NCT07164105

Conditions

PTSD and Trauma-related Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Low intensity focused ultrasound

Sham modulation

Study Details

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

Study ID

NCT07164105

Start date

Dec 29, 2025

Status verified date

Apr, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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, OR at least partial PTSD as measured by the MINI
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

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Low intensity focused ultrasound (LIFU)

LIFU of the ventral anterior cingulate cortex

sham comparator: Sham

Sham neuromodulation (Sorbothane membrane over ultrasound probe)

Interventions

Low intensity focused ultrasound

Low intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex

Sham modulation

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

Primary outcome measure

  • LIFU target engagement [ Time Frame: Study day 1 to day 7 (plus or minus 3 days) ]
  • Behavioral changes [ Time Frame: Day 0 to Day 7 (plus or minus 3 days) ]

Central Contacts and Locations

Central contacts

Locations

Laureate Institute for Brain Research

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Principal Investigator:

Adrienne Taren, MD, PhD

More Information

Sponsor

Laureate Institute for Brain Research, Inc.

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laureate Institute for Brain Research, Inc. on 2026-04-20.