The PREVENT Resilience Study
PREVENT Study: Promoting Resilience Via Early Neurostimulation After Trauma
研究概览
详细说明
After experiencing a traumatic event, there is a risk of developing Post-Traumatic Stress Disorder, which can disrupt everyday life and functioning. It is now well-recognized that many individuals experience initial psychological symptoms acutely following a traumatic event, but many recover naturally within the first 3 months post-trauma. However, about 20% of individuals continue to maintain high levels of debilitating symptoms that can persist for years following the trauma in the absence of treatment. Initial hyperarousal is a predictor of subsequent re-experiencing and avoidance symptoms. Such chronic symptoms present the greatest burden to individuals, associated with increasingly ingrained behavioral responses such as avoidance, decreasing quality of life, and the physiological consequences of chronic allostatic load, including cardiovascular and metabolic disorders. The burden to society is similarly tremendous, and annual costs associated with chronic post-trauma psychopathology are estimated to exceed $230 billion.
Interventions in the early post-trauma period could therefore provide an immense benefit to society by enhancing mechanisms that lead to recovery and resilience, thereby reducing chronic trauma-related psychopathology. This study is being done to test Transcranial Magnetic Stimulation (TMS) for early intervention for Post-Traumatic Stress Disorder. Researchers will test TMS in the weeks following a psychological trauma among individuals experiencing symptoms associated with acute stress. This usage of TMS is experimental. The study is being done to learn more about whether brain stimulation in the weeks after a trauma can change brain activity that is linked to Post-Traumatic Stress Disorder.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Sanne van Rooij, PhD
- 电话号码：404-251-8926
- 邮箱：sanne.van.rooij@emory.edu
学习地点
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Georgia
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Atlanta、Georgia、美国、30303
- 招聘中
- Grady Memorial Hospital
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Atlanta、Georgia、美国、30329
- 招聘中
- Emory Brain Health Center
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Men and women 18-65 years of age. (Assessed via self-reported and medical record-based Date of Birth)
- Trauma-exposed within the last 2 weeks (Endorsement of having experienced an event that could have caused death, serious injury, or sexual violence)
- High initial symptoms of PTSD related to the index trauma - PCL-5 >30 AND at least 2 symptoms of hyperarousal.
- Low symptoms of PTSD related to a previous lifetime trauma - PCL-5<31AND does not meet for all four DSM-5 clusters.
- Participants may be on psychotropic medication, including antidepressants, antipsychotics, benzodiazepines and anticonvulsants, but the dosage of the medication must be stable for at least 6 weeks and not change during the course of the study (Assessed via self-report during the screening phone call).
- Capable and willing to provide informed consent.
Exclusion Criteria:
- Having active suicidal intent or plan, or in the clinician's opinion, is likely to attempt suicide within the next six months. (Assessed via the Patient Health Questionnaire-9 (PHQ-9) during the screening phone call)
- Lifetime diagnosis of psychotic disorder or bipolar disorder per psychiatric screener. (Assessed via self-report during the screening phone call)
- Diagnosed with the following conditions: a neurological disorder, including a history of seizures, cerebrovascular disease, primary or secondary tumors in the central nervous system (CNS), stroke, cerebral aneurysm or movement disorder or any lifetime history of loss of consciousness for more than 5 minutes due to head injury (Assessed via self-report during the screening phone call)
- History of cranial surgery, metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes), or implanted medical pumps. (Assessed via self-report during the screening phone call)
- For women, being pregnant. (Assessed via self-report during the screening phone call, the medical record, and cycling females will undergo a pregnancy test at TMS Day 1)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Transcranial Magnetic Stimulation (TMS)
All participants will complete two days that will contain both neuroimaging and TMS components and will take approximately 4 hours.
Some TMS components will consist of active TMS, and other TMS components will consist of sham (placebo) TMS.
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Transcranial Magnetic Stimulation (TMS) is a non-invasive, FDA-approved procedure for pharmaco-resistant depression and is widely used in clinical and research settings.
It uses magnetic pulses to stimulate underactive nerve cells in the brain, primarily treating depression and obsessive-compulsive disorder (OCD) when other treatments fail.
It is a safe, outpatient treatment, usually involving a 20-40 minute session.
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假比较器：Control Application
All participants will experience multiple single-blind sham control TMS sessions (30-minute sessions) and post-sham MRI scan.
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TMS Sham is equivalent to a drug placebo.
The experience is the same with the noise and vibration of the TMS coil, however, no magnetic stimulation occurs.
Participants will be blinded to the condition during the TMS days to prevent bias in responding during the MRI tasks
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Amygdala Reactivity During Fear Processing Pre- to Post TMS
大体时间：Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention
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Amygdala reactivity during fear processing will be assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while amygdala reactivity was measured. The amygdala will be separated into the right and left hemispheres. The right amygdala is the primary outcome measure. fMRI measures the blood oxygen level-dependent response, a measure of how much more oxygenated blood there is in a certain brain region, which reflects activation of the brain region. For analysis of amygdala reactivity to threat cues, volume-averaged beta values for each condition (fearful faces, neutral faces) will be extracted. Right amygdala threat reactivity will be compared between receiving any versus no TMS |
Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Response assessment of amygdala threat reactivity for different doses
大体时间：Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention
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Change in amygdala threat reactivity, defined as blood oxygen level-dependent (BOLD) response to threat-related stimuli measured by functional magnetic resonance imaging (fMRI), comparing different doses of TMS.
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Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention
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合作者和调查者
调查人员
- 首席研究员：Sanne van Rooij, PhD、Emory University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2025P011175
- 1R61MH138733-01A1 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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