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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low intensity focused ultrasound (LIFU) 		LIFU of the ventral anterior cingulate cortex
  • Device: Low intensity focused ultrasound
    Low intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex
    Other names:
    • LIFU
Sham Comparator
Sham 		Sham neuromodulation (Sorbothane membrane over ultrasound probe)
  • Device: Sham modulation
    Low intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission

Recruiting Locations

Laureate Institute for Brain Research
Tulsa 4553433, Oklahoma 4544379 74136
Contact:
Adrienne Taren, MD, PhD
918-340-4116
ataren@laureateinstitute.org

More Details

Status
Recruiting
Sponsor
Laureate Institute for Brain Research, Inc.

Study Contact

Adrienne Taren, MD, PhD
918-340-4116
ataren@laureateinstitute.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.