Recruiting

Brain Stimulation

Sponsor:

Emory University

Code:

NCT07568145

Conditions

Psychological Trauma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Transcranial Magnetic Stimulation (TMS)

TMS Sham

Study Details

Brief 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. 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).

Conditions

Psychological Trauma

Study ID

NCT07568145

Start date

Jun 18, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: Control Application

All participants will experience multiple single-blind sham control TMS sessions (30-minute sessions) and post-sham MRI scan.

Interventions

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.

TMS Sham

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

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 ]

Central Contacts and Locations

Central contacts

Sanne van Rooij, PhD

404-251-8926sanne.van.rooij@emory.edu

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Emory Brain Health Center

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Post-Traumatic Stress Disorder
  • Transcranial Magnetic Stimulation (TMS)
  • Resilience

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-09-08.