Recruiting

aTMS

Sponsor:

Brigham and Women's Hospital

Code:

NCT07245641

Conditions

Post Traumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Study Details

Brief summary:

Post-traumatic stress disorder (PTSD) is a highly prevalent and debilitating condition among veterans and active-duty military personnel, with rates as high as 30% in certain combat-exposed populations. Conventional treatments such as prolonged exposure therapy and pharmacotherapy have limited efficacy and high dropout rates, highlighting the need for novel, rapidly effective interventions.

Transcranial magnetic stimulation (TMS) has been well established for treatment-resistant depression (TRD). Traditional TMS, which involves 6 to 7 weeks of daily, weekday scalp-targeted treatment, shows open-label response and remission rates of 58.1% and 30%, respectively. However, such protocols may be impractical for military personnel with limited medical leave. A new form of accelerated TMS (aTMS) that involves 10 imaging-guided treatments per day for 5 consecutive days has demonstrated substantial antidepressant benefits within days and response rates of 69% at 1-month follow-up. This protocol has not been tested for PTSD, in part because there was no causally informed brain circuit target. In this study, the investigators will test aTMS for PTSD using a novel PTSD circuit that the investigators have derived.

Conditions

Post Traumatic Stress Disorder (PTSD)

Study ID

NCT07245641

Start date

Dec 15, 2025

Status verified date

Jan, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Age 18-65
  • DSM-5 diagnosis of PTSD per PTSD Checklist for DSM-5 (CAPS-5)
  • At least moderate symptoms of PTSD per PCL-5 (≥21)
  • English proficiency sufficient to understand risks/benefits
  • No new medications or medication increases before, during, or after aTMS
  • Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial
  • Agreement to lifestyle considerations:
  • Abstain from becoming pregnant from screening to one-month after treatment (the MRI visit)
  • Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment
  • No changes to routine intake of alcohol, tobacco, and recreational drugs if patients are using them at baseline for at least 24 hours before the start of each MRI and TMS session

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active aiTBS

Participants in this group will receive active aiTBS with neuronavigation to a treatment target identified with individualized resting state functional connectivity.

sham comparator: Sham aiTBS

Participants in this group will receive sham aiTBS with neuronavigation to a treatment target identified with individualized resting state functional connectivity. Participants in the sham group who continue to present with moderate PTSD symptoms (greater than or equal to 33 cutoff on PCL-5) at the post-treatment month 1 visit will be offered the opportunity to opt in and receive another course of active aTMS.

Interventions

Transcranial Magnetic Stimulation

Transcranial magnetic stimulation (TMS) is a focal, non-invasive form of brain stimulation that has FDA clearance for depression. In this study, a form of TMS called accelerated intermittent theta burst stimulation (aiTBS) will be administered under the supervision of a physician with TMS expertise.

Primary outcome measure

  • PTSD Checklist with Criterion A for DSM-5 (PCL-5) [ Time Frame: Before treatment to 1-month post treatment ]

Central Contacts and Locations

Central contacts

Interventional Psychiatry Research Group

6175253526bwhtap@mgb.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 13, 2026

Last verified

Jan, 2026

Keywords

  • Accelerated Transcranial Magnetic Stimulation
  • Post traumatic stress disorder
  • PTSD
  • TMS
  • Neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-08-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.