The PREVENT Resilience Study
PREVENT Study: Promoting Resilience Via Early Neurostimulation After Trauma
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sanne van Rooij, PhD
- 電話番号：404-251-8926
- メール：sanne.van.rooij@emory.edu
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30303
- 募集
- Grady Memorial Hospital
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Atlanta、Georgia、アメリカ、30329
- 募集
- Emory Brain Health Center
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Amygdala Reactivity During Fear Processing Pre- to Post TMS
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Response assessment of amygdala threat reactivity for different doses
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Sanne van Rooij, PhD、Emory University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2025P011175
- 1R61MH138733-01A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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