- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07568145
The PREVENT Resilience Study
PREVENT Study: Promoting Resilience Via Early Neurostimulation After Trauma
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sanne van Rooij, PhD
- 전화번호: 404-251-8926
- 이메일: sanne.van.rooij@emory.edu
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30303
- Grady Memorial Hospital
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Atlanta, Georgia, 미국, 30329
- Emory Brain Health Center
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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 - PTSD Checklist for Diagnostic and Statistical Manual( DSM)-5 (PCL-5) >30 with 2+ hyperarousal symptoms
- Low symptoms of PTSD related to a previous lifetime trauma - PCL-5<31
- 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, intra-cranial 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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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가짜 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Amygdala Reactivity During Fear Processing Pre- to Post TMS
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Response assessment of amygdala threat reactivity for different doses
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Sanne van Rooij, PhD, Emory University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025P011175
- 1R61MH138733-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Riverside University Health System Medical Center알려지지 않은
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Transcranial Magnetic Stimulation (TMS)에 대한 임상 시험
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Hospital Center Guillaume Régnier모병
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The Mind Research NetworkUniversity of New Mexico모집하지 않고 적극적으로
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Mayo ClinicNational Institute of Mental Health (NIMH)모병
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Boston Children's HospitalEncoded Therapeutics모병
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Centre for Addiction and Mental Health모집하지 않고 적극적으로
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Boston Children's Hospital알려지지 않은
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Boston Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of South Florida 그리고 다른 협력자들모병