Mechanisms of Low Intensity Focused Ultrasound of the Ventral Anterior Cingulate Cortex for Post-Traumatic Stress Disorder in Frontline Healthcare Workers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- LIFU target engagement
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Low intensity focused ultrasound (LIFU)
LIFU of the ventral anterior cingulate cortex
干预措施: Low intensity focused ultrasound (Device)
Sham
Sham neuromodulation (Sorbothane membrane over ultrasound probe)
干预措施: Sham modulation (Device)
结局指标
主要结局
LIFU target engagement
时间窗: Study day 1 to day 7 (plus or minus 3 days)
Percent BOLD signal change in vACC and amygdala regions of interest
Behavioral changes
时间窗: Day 0 to Day 7 (plus or minus 3 days)
Change in reaction time (ms) and error rate (percentage of correct answers) on emotional conflict task; difference between optimal and observed flight initiation distance.
次要结局
- fMRI-PTSD Symptom Correlation(Day 0 to day 14 (plus or minus 6))
- fMRI-Emotion Regulation Correlation(Day 0 to day 14 (plus or minus 6))
- LIFU effects on PTSD symptoms(Dy 0 to day 14 (plus or minus 6))
- LIFU effects on physiology(Day 0 to day 14 (plus or minus 6 days))
- fMRI-heart rate variability correlation(Day 0 to day 14 (plus or minus 6))
- fMRI-resting heart rate correlation(Day 0 to day 14 (plus or minus 6))
- fMRI-REM sleep correlation(Day 0 to day 14 (plus or minus 6))
- fMRI-deep sleep correlation(Day 0 to day 14 (plus or minus 6))