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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low intensity focused ultrasound (LIFU) | Experimental | LIFU of the ventral anterior cingulate cortex |
|
| Sham | Sham Comparator | Sham neuromodulation (Sorbothane membrane over ultrasound probe) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity focused ultrasound | Device | Low intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex |
|
| Measure | Description | Time Frame |
|---|---|---|
| LIFU target engagement | Percent BOLD signal change in vACC and amygdala regions of interest | Study day 1 to day 7 (plus or minus 3 days) |
| Behavioral changes | Change in reaction time (ms) and error rate (percentage of correct answers) on emotional conflict task; difference between optimal and observed flight initiation distance. | Day 0 to Day 7 (plus or minus 3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| LIFU effects on physiology | Change in heart rate variability (ms), change in resting heart rate (beats per minute), change in %REM sleep (minutes), change in %deep sleep (minutes) as measured by Oura Ring | Day 0 to day 14 (plus or minus 6 days) |
| LIFU effects on PTSD symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrienne Taren, MD, PhD | Contact | 918-340-4116 | ataren@laureateinstitute.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laureate Institute for Brain Research | Recruiting | Tulsa | Oklahoma | 74136 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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|
| Sham modulation | Device | Low intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission |
|
Change in PCL-5 score |
| Dy 0 to day 14 (plus or minus 6) |
| fMRI-heart rate variability correlation | Correlations between vACC/amygdala BOLD signal extracted beta-weights and heart rate variability (ms) as measured by Oura Ring | Day 0 to day 14 (plus or minus 6) |
| fMRI-resting heart rate correlation | Correlations between vACC/amygdala BOLD signal extracted beta-weights and resting heart rate (beats per minute) as measured by Oura ring | Day 0 to day 14 (plus or minus 6) |
| fMRI-REM sleep correlation | Correlations between vACC/amygdala BOLD signal extracted beta-weights and %REM sleep (minutes) as measured by Oura ring | Day 0 to day 14 (plus or minus 6) |
| fMRI-deep sleep correlation | Correlations between vACC/amygdala BOLD signal extracted beta-weights and %deep sleep (minutes) as measured by Oura ring | Day 0 to day 14 (plus or minus 6) |
| fMRI-PTSD Symptom Correlation | Correlations between vACC/amygdala BOLD signal extracted beta-weights and PCL-5 score. | Day 0 to day 14 (plus or minus 6) |
| fMRI-Emotion Regulation Correlation | Correlations between vACC/amygdala BOLD signal extracted beta-weights and Cognitive-Emotion Regulation Questionnaire Score. | Day 0 to day 14 (plus or minus 6) |