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NCT Number: NCT07245641

Targeted Accelerated TMS for Post-Traumatic Stress Disorder

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.

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Key information

Conditions

Post Traumatic Stress Disorder (PTSD) Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

About this study

In a recent study in Nature Neuroscience, the investigators analyzed three independent datasets to derive a brain circuit causally linked to PTSD in military veterans. Investigators found that brain lesions that reduce the probability of developing PTSD (n=193) were connected to the same brain circuit based on the functional connectivity profiles of individual patients with PTSD using fMRI (n=180). Finally, investigators demonstrated that scalp-targeted TMS to our circuit rapidly improved PTSD symptoms (n=20).

Separately, the investigators partnered with a private clinic to administer open-label, circuit-targeted aTMS to patients with PTSD (n=8). Investigators found that the treatment was safe and tolerable. Response and remission rates were 75% and 63%, respectively. Of note, these response and remission rates assess outcomes up to 4 weeks after the treatment ends. This approach captures individual variability in response trajectory and aligns with our own data from aTMS treatment of TRD.

The strength of these findings has inspired us to launch a pilot randomized controlled aTMS trial in which the investigators prospectively target our PTSD circuit using each patient's neuroimaging data in combination with the accelerated TMS treatment protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial magnetic stimulation

Procedure

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.

Other names: TMS, Accelerated intermittent theta burst stimulation, aiTBS

Primary outcomes

  1. PTSD Checklist with Criterion A for DSM-5 (PCL-5)

    Time frame: Before treatment to 1-month post treatment

    20 item PTSD scale, scored 0-80. Higher scores indicate worse symptoms. Investigators will use a repeated measures mixed model to examine the effect of treatment on PCL-5 scores over time as well as a group x time interaction not controlling for depression.

    Hypothesis: There will be a significant difference in PCL-5 score magnitude of change one month after treatment relative to baseline in the participants receiving active treatment vs. sham

Secondary outcomes

  1. PTSD Checklist with Criterion A for DSM-5 (PCL-5)

    Time frame: Before treatment to 1-month post treatment

    20 item PTSD scale, scored 0-80. Higher scores indicate worse symptoms. Investigators will determine between-group effect size based on the change in PCL-5 score one month after treatment.

    Hypothesis: Relative to sham aTMS, active aTMS will show a moderate-to-large effect size.

Other outcomes

  1. Clinician-Administered PTSD Scale for DSM-5 (CAP-5)

    Time frame: Before treatment and 1 month after treatment

    30-item clinical interview designed to assess PTSD based on DSM-5 criteria. Total scores from 0-80, with higher numbers indicating greater PTSD symptom severity.

  2. Clinically Useful Anxiety Outcome Scale (CUXOS)

    Time frame: Before treatment and daily for 5 treatment days

    20-item, self-report questionnaire that measures the severity of psychic and somatic anxiety symptoms. Scores range from 0-80, which higher scores indicating higher symptoms of anxiety.

  3. Beck Depression Inventory (BDI)

    Time frame: Before treatment, 1 week post treatment, and 1 month post treatment

    Depression severity rating scales (0-63, higher numbers indicate higher severity)

  4. Beck Anxiety Inventory (BAI)

    Time frame: Before treatment, 1 week post treatment, and 1 month post treatment

    Anxiety severity rating scale (0-63, higher numbers indicate higher severity)

  5. Young Mania Rating Scale (YMRS)

    Time frame: Before treatment, daily for 5 treatment days, and 1 month post treatment

    11 item scale evaluating mania. Scored 0-60. Higher score indicates worse outcome/higher mania

  6. Patient Global Impressions (PGI)

    Time frame: Before and 1 month after treatment

    A single question assessing a patient's perception of their health or condition. Scores range from 1-7, one being the participant believes they are not at all ill, seven being an extremely ill individual.

  7. Clinical Global Impression Scale (CGI)

    Time frame: Before and 1 month after treatment

    Clinician-rated tool to assess the global severity of a patient's illness. 7-point scale from 1 (very much improved) to 7 (very much worse).

  8. Adult Temperament Questionnaire

    Time frame: Before treatment and 1 month after treatment

    77-item self-report questionnaire assessing individuals temperament and personality. Scores range from 0-539, with scores in subsections of the questionnaire indicating various affects and temperaments.

  9. World Health Organization Disability Assessment Schedule II (WHODAS 2.0)

    Time frame: Before treatment and 1 month after treatment

    36-item functional assessment (each question rated 1-5) Minimum: 36 Maximum: 180 Can also be scored by percentiles Higher score indicates more disability

  10. World Health Organization Quality of Life (WHOQOL-BREF)

    Time frame: Before treatment and 1 month after treatment

    26-item questionnaire assessing an individual's perception of their quality of life (scores range from 0 to 100, where higher scores represent a better quality of life).

  11. Visual Analog Scale (Mood)

    Time frame: Before treatment and daily for 5 treatment days

    A single question asking participants to rate their current mood on a scale of 1-100 (higher scores indicate positive mood)

  12. Adult Attention Deficit/Hyperactivity Disorder Self-Report Scale (AARS)

    Time frame: Before treatment and 1 month after treatment

    ADHD rating scale (each question rated 1-5, higher scores indicate symptoms highly consistent with ADHD)

  13. Illness Intrusiveness Rating Scale (IIRS)

    Time frame: Before treatment and 1 month after treatment

    3 item scale measuring how illness affects function. Scored 13-91, higher score indicates higher illness intrusiveness severity

  14. McLean Screening Instrument for Borderline Personality Disorder (MS-BPD)

    Time frame: Before treatment and 1 month after treatment

    10-item questionnaire used to screen for BPD (scores range from 0 to 10; higher scores are associated with higher levels of/more severe BPD symptoms).

  15. Perceived Stress Scale (PSS)

    Time frame: Before treatment and 1 month after treatment

    Stress assessment scored 0-40, higher scores indicate higher stress

  16. Social Readjustment Rating Scale (SRRS)

    Time frame: Before and 1 month after treatment

    A tool used to assess the potential stress associated with different life events (scores range from 0 to 430, with higher scores indicating higher levels of stress).

  17. Pittsburgh sleep quality index (PSQI)

    Time frame: Before and 1 month after treatment

    Self-report questionnaire to assess sleep quality, scored from 0 to 21. Higher scores indicate poorer sleep quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Interventional Psychiatry Research Group

CONTACT

[email protected]

6175253526

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Mass General Home Base Program

Registry information

Acronym: TAP

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 24, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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