Psychological TraumaNCT07568145
The PREVENT Resilience Study
A study testing Transcranial Magnetic Stimulation (TMS) in people with Psychological Trauma, run by Emory University at 2 sites in United States.
Trial summary
PTSD is one of the most universal and severe psychiatric disorders whose incidence continues to rise due to the common exposure to severe trauma in the United States and worldwide. After trauma, a proportion of individuals maintains high symptoms of PTSD and depression, which can persist for years. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Trauma
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
- Recruiting
Emory Brain Health Center
Atlanta, Georgia, 30329
About this study
Official title: PREVENT Study: Promoting Resilience Via Early Neurostimulation After Trauma
PTSD is one of the most universal and severe psychiatric disorders whose incidence continues to rise due to the common exposure to severe trauma in the United States and worldwide. After trauma, a proportion of individuals maintains high symptoms of PTSD and depression, which can persist for years. The early weeks following trauma present a unique opportunity to deliver early interventions that can prevent chronic PTSD and depression from occurring, and the researchers propose a brain-based intervention that will reduce reactivity to threat, an early risk mechanism for chronic PTSD. This 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 (PTSD).
Read the detailed description
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.
- Conditions
- Psychological Trauma
- Being tested
- Transcranial Magnetic Stimulation (TMS), TMS Sham
- Keywords
- Post-Traumatic Stress Disorder, Transcranial Magnetic Stimulation (TMS), Resilience
- Medical subject headings
- Psychological Trauma, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
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.
TMS ShamOther
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
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | 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. Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| Control Application | Sham comparator | All participants will experience multiple single-blind sham control TMS sessions (30-minute sessions) and post-sham MRI scan. Receives: Other: TMS Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amygdala Reactivity During Fear Processing Pre- to Post TMS
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
Measured: Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention
Secondary outcomes (1)
Response assessment of amygdala threat reactivity for different doses
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.
Measured: Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start18 Jun 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sanne van Rooij, Emory University
- Investigators
- Sanne van Rooij, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568145
- Sponsor's protocol ID
- 2025P011175
- Other IDs
- 1R61MH138733-01A1
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The research team will share Individual Participant data that has been deidentified with the National Institute of Mental Health (NIMH) Data Archive (DA) as per the terms of the grant
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENT Study: Promoting Resilience Via Early Neurostimulation After Trauma
- ClinicalTrials.gov ID
- NCT07568145
- Acronym / sponsor ID
- 2025P011175
- Conditions
- Psychological Trauma
- Keywords
- Post-Traumatic Stress Disorder, Transcranial Magnetic Stimulation (TMS), Resilience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PTSD is one of the most universal and severe psychiatric disorders whose incidence continues to rise due to the common exposure to severe trauma in the United States and worldwide. After trauma, a proportion of individuals maintains high symptoms of PTSD and depression, which can persist for years. The early weeks following trauma present a unique opportunity to deliver early interventions that can prevent chronic PTSD and depression from occurring, and the researchers propose a brain-based intervention that will reduce reactivity to threat, an early risk mechanism for chronic PTSD. This 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 (PTSD).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | Device: 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. |
| Control Application | Sham comparator | Other: TMS ShamAll participants will experience multiple single-blind sham control TMS sessions (30-minute sessions) and post-sham MRI scan. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)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. | Device | Transcranial Magnetic Stimulation (TMS) |
| TMS ShamTMS 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 | Other | Control Application |
Primary outcome
Amygdala Reactivity During Fear Processing Pre- to Post TMS
Time frame: Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention
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
1 secondary outcome
Response assessment of amygdala threat reactivity for different doses
Time frame: Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. The research team will share Individual Participant data that has been deidentified with the National Institute of Mental Health (NIMH) Data Archive (DA) as per the terms of the grant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanne van Rooij, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Psychological Trauma, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanne van Rooij, PhD (404-251-8926, sanne.van.rooij@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amygdala Reactivity During Fear Processing Pre- to Post TMS (time frame: Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.