LIFU Mechanisms for PTSD in Healthcare Workers

Официальное название

Mechanisms of Low Intensity Focused Ultrasound of the Ventral Anterior Cingulate Cortex for Post-Traumatic Stress Disorder in Frontline Healthcare Workers

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Low intensity focused ultrasound
  Low intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex
• Устройство Sham modulation
  Low intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission

Первичные конечные точки

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

Вторичные конечные точки (8)

• LIFU effects on physiology [Срок оценки: Day 0 to day 14 (plus or minus 6 days)]
• LIFU effects on PTSD symptoms [Срок оценки: Dy 0 to day 14 (plus or minus 6)]
• fMRI-heart rate variability correlation [Срок оценки: Day 0 to day 14 (plus or minus 6)]
• fMRI-resting heart rate correlation [Срок оценки: Day 0 to day 14 (plus or minus 6)]
• fMRI-REM sleep correlation [Срок оценки: Day 0 to day 14 (plus or minus 6)]
• fMRI-deep sleep correlation [Срок оценки: Day 0 to day 14 (plus or minus 6)]
• fMRI-PTSD Symptom Correlation [Срок оценки: Day 0 to day 14 (plus or minus 6)]
• fMRI-Emotion Regulation Correlation [Срок оценки: Day 0 to day 14 (plus or minus 6)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Laureate Institute for Brain Research — Tulsa

Идентификаторы

NCT: NCT07164105 · 20252812

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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