Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Post Traumatic Stress Disorder
In brief
The purpose of this study is to examine the benefits of combining repetitive Transcranial Magnetic Stimulation (rTMS) coupled with Cognitive Processing Therapy (CPT) in treating combat-related Posttraumatic Stress Disorder (PTSD) symptoms. The study will also examine change in depression, psychosocial functioning, and neurophysiological (i.e., electroencephalography and magnetic resonance images) measures.
Key facts
- Study ID
- NCT03932773
- Run by
- The University of Texas at Dallas
- People needed
- 330
- Starts
- 2019-05-01
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Veterans of Post-9/11 military conflicts
- with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat
You may not qualify if…
- 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
Where it is running
- Florida State University College of Medicine — Tallahassee, Florida, United States (enrolling)
- Metrocare Services of Dallas — Addison, Texas, United States (enrolling)
- The University of Texas at Dallas — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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