- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07568145
The PREVENT Resilience Study
PREVENT Study: Promoting Resilience Via Early Neurostimulation After Trauma
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Sanne van Rooij, PhD
- Telefonní číslo: 404-251-8926
- E-mail: sanne.van.rooij@emory.edu
Studijní místa
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Georgia
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Atlanta, Georgia, Spojené státy, 30303
- Grady Memorial Hospital
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Atlanta, Georgia, Spojené státy, 30329
- Emory Brain Health Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Falešný srovnávač: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Amygdala Reactivity During Fear Processing Pre- to Post TMS
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Response assessment of amygdala threat reactivity for different doses
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Sanne van Rooij, PhD, Emory University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025P011175
- 1R61MH138733-01A1 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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