LIFU Mechanisms for PTSD in Healthcare Workers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low intensity focused ultrasound, Sham modulation.
- Who it may be relevant to
- Registry conditions: PTSD and Trauma-related Symptoms. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mechanisms of Low Intensity Focused Ultrasound of the Ventral Anterior Cingulate Cortex for Post-Traumatic Stress Disorder in Frontline Healthcare Workers
Overview
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
Detailed description
The study employs a double-blind, randomized, sham-controlled design to evaluate whether low-intensity focused ultrasound (LIFU) targeting the ventral anterior cingulate cortex (vACC) can normalize fronto-limbic circuitry and reduce post-traumatic stress symptomatology in frontline healthcare workers. Sixty-six frontline healthcare professionals aged 18-65 (PCL-5 ≥ 33 or at least partial PTSD on the MINI) will complete baseline assessments that include structural MRI, resting-state fMRI, and two task-based scans. Concurrently, participants initiate continuous Oura Ring wearable monitoring and daily ecological momentary assessment (EMA) surveys. Subjects will return for active or sham LIFU neuromodulation of the vACC. Before and after LIFU, identical MRI and questionnaire batteries quantify acute neural and behavioral change.
Interventions
- Device Low intensity focused ultrasound
Low intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex - Device Sham modulation
Low intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission
Primary outcome measures
- 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)]
Secondary outcome measures (8)
- LIFU effects on physiology [Time frame: Day 0 to day 14 (plus or minus 6 days)]
- LIFU effects on PTSD symptoms [Time frame: Dy 0 to day 14 (plus or minus 6)]
- fMRI-heart rate variability correlation [Time frame: Day 0 to day 14 (plus or minus 6)]
- fMRI-resting heart rate correlation [Time frame: Day 0 to day 14 (plus or minus 6)]
- fMRI-REM sleep correlation [Time frame: Day 0 to day 14 (plus or minus 6)]
- fMRI-deep sleep correlation [Time frame: Day 0 to day 14 (plus or minus 6)]
- fMRI-PTSD Symptom Correlation [Time frame: Day 0 to day 14 (plus or minus 6)]
- fMRI-Emotion Regulation Correlation [Time frame: Day 0 to day 14 (plus or minus 6)]
Eligibility criteria
Inclusion criteria
- Adults in a frontline healthcare position (e.g. emergency medical services)
- Ages 18-65 years
- PTSD Checklist for DSM-5 (PCL-5) score ≥ 33 and < 65, OR at least partial PTSD as measured by the MINI
- English proficiency as evaluated by language ability during screening
Exclusion criteria
- Neurological disorders
- 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
- 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.
- History of severe traumatic brain injury (as indicated by score ≥ 3 on the Tulsa Head Injury Screen) or of skull fractures
- Contraindications to MRI as determined by the MR Environment Screening
- Pregnancy, determined by urine pregnancy test administered prior to every MRI scanning procedure
- Evidence of inability to comply with study procedures based on experimenter judgement.
- 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.
- Non-correctable vision or hearing problems
- Unstable medical diagnoses
- Any structural abnormalities in the LIFU target region on screening brain MRI.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Laureate Institute for Brain Research — Tulsa
Identifiers
NCT: NCT07164105 · 20252812