LIFU Mechanisms for PTSD in Healthcare Workers

Laureate Institute for Brain Research (LIBR)

Status: Enrolling

Conditions: PTSD and Trauma-related Symptoms

Treatments: Device: Sham modulation; Device: Low intensity focused ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07164105

20252812

Details and patient eligibility

About

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

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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
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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups

Low intensity focused ultrasound (LIFU)

Experimental group

Description:

LIFU of the ventral anterior cingulate cortex

Treatment:

Device: Low intensity focused ultrasound

Sham

Sham Comparator group

Description:

Sham neuromodulation (Sorbothane membrane over ultrasound probe)

Treatment:

Device: Sham modulation