The PREVENT Resilience Study
PREVENT Study: Promoting Resilience Via Early Neurostimulation After Trauma
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Sanne van Rooij, PhD
- Puhelinnumero: 404-251-8926
- Sähköposti: sanne.van.rooij@emory.edu
Opiskelupaikat
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30303
- Rekrytointi
- Grady Memorial Hospital
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Atlanta, Georgia, Yhdysvallat, 30329
- Rekrytointi
- Emory Brain Health Center
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Huijausvertailija: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Amygdala Reactivity During Fear Processing Pre- to Post TMS
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Response assessment of amygdala threat reactivity for different doses
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Sanne van Rooij, PhD, Emory University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2025P011175
- 1R61MH138733-01A1 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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