Study of rTMS and CPT for Combat-Related PTSD

This study is looking at new ways to treat combat-related Posttraumatic Stress Disorder (PTSD) in veterans. It's testing if combining repetitive Transcranial Magnetic Stimulation (rTMS), a device that uses magnetic pulses, with Cognitive Processing Therapy (CPT), a type of talk therapy, can better reduce PTSD symptoms. You might receive rTMS before CPT, sham rTMS (a placebo version of rTMS) before CPT, or rTMS alone. The study aims to enroll 330 participants, aged 18-60, who are Post-9/11 military veterans with a PTSD diagnosis related to combat. Success will be measured by changes in your PTSD symptom severity six months after treatment, using a standard assessment called CAPS-5. The current status of this study is unclear.

Study design
This interventional study will randomly assign 330 participants to one of three treatment groups. It compares active rTMS plus CPT, sham rTMS plus CPT, and active rTMS alone.
What's involved
You would undergo 12 sessions of treatment, which may include rTMS and/or CPT. You will also have assessments before, during, and after treatment, including neuropsychological tests, EEG, and MRI scans.
Compensation
Not stated in the trial record.
Follow-up
Your PTSD symptoms and other measures will be checked at 1-month, 6-months, and 12-months after treatment completion.

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NCT03932773

Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD

Recruiting
NAAges 18–60InterventionalTreatment
The University of Texas at Dallas
~330 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Active rTMSSham rTMSCognitive Processing Therapy

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment group differences in change from baseline to 6-months post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score
Measured over Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Post Traumatic Stress Disorder
3 sites across 2 states
Texas2
Florida1
  • John Hart, Jr., MD · PRINCIPAL_INVESTIGATOR · The University of Texas at Dallas
  • F. Andrew Kozel, MD · PRINCIPAL_INVESTIGATOR · Florida State University
  • John Burruss, MD · PRINCIPAL_INVESTIGATOR · Metrocare Services of Dallas

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Veterans of Post-9/11 military conflicts
with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat

Exclusion

current enrollment in an acute experimental treatment for PTSD or trauma-focused psychotherapy treatment
PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation
history of epilepsy or seizure disorder, a history of major head trauma,
any neurologic condition likely to increase risk of seizures,
brain tumors,
moderate to severe substance use disorder in last 3 months or any substance use that puts the participant at increased risk or significant impairment
stroke, and blood vessel abnormalities in the brain,
dementia,
Parkinson's disease, Huntington's chorea, or multiple sclerosis
a high suicide risk
a lifetime history of psychotic disorder or bipolar disorder
inability to stop taking any medication that significantly lowers the seizure threshold
pregnant or nursing
metal fragments in the head, or any metal objects in or near the head that cannot be safely removed
We will screen for a history of traumatic brain injury and exclude potential participants from the study if they have a history of severe TBI or are at high risk for seizures.
history of seizures
non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except for English
cardiac pacemaker, implanted medication pumps of any sort that would increase the risk of rTMS
any current medical condition that could preclude being able to safely participate in TMS treatment,
use of prescription medication or illegal substances that lower the seizure threshold
previous rTMS
  • Treatment group differences in change from baseline to 6-months post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity ScoreOutcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment

    Evaluation of treatment group differences on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 6 months after the 12-week interventions. Weathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, \& Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013.