TMS Early Intervention After Trauma to Boost Resilience

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests Transcranial Magnetic Stimulation (TMS) as an early intervention after a traumatic event. Participants are adults who recently experienced trauma and have higher PTSD symptoms but no prior full PTSD from earlier traumas. They are randomly assigned to active TMS or a sham procedure to see if brain stimulation changes neural reactivity related to threat and reduces the chance of chronic PTSD. The approach focuses on the weeks following trauma, a critical window where early treatment may improve outcomes. The study is conducted at Grady Memorial Hospital and Emory Brain Health Center in Atlanta, with Emory University as the lead sponsor and NIMH collaboration.

Why it matters

Who can join: the full rules

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)

Where it's running

• Grady Memorial Hospital
  Atlanta, Georgia, United States Recruiting
• Emory Brain Health Center
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Sanne van Rooij, PhD — Emory University
• Study coordinator: Sanne van Rooij, PhD
• Email: sanne.van.rooij@emory.edu
• Phone: 404-251-8926

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.