Combining rTMS and Cognitive Therapy for Combat-related PTSD
Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
This study is testing whether combining a brain treatment called rTMS with therapy can help veterans with combat-related PTSD feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The University of Texas at Dallas Academic / other |
| Locations | 3 sites (Tallahassee, Florida and 2 other locations) |
| Trial ID | NCT03932773 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining repetitive Transcranial Magnetic Stimulation (rTMS) with Cognitive Processing Therapy (CPT) to treat combat-related Posttraumatic Stress Disorder (PTSD) in veterans. Participants will be randomly assigned to one of three treatment arms: active rTMS followed by CPT, sham rTMS followed by CPT, or rTMS alone. The study will assess changes in PTSD symptoms, depression, psychosocial functioning, and neurophysiological measures through various assessments at multiple time points. The goal is to determine the most effective treatment approach for alleviating PTSD symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans of Post-9/11 military conflicts diagnosed with PTSD.
Not a fit: Patients currently enrolled in acute experimental treatments for PTSD or those with certain neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce PTSD symptoms in veterans, improving their overall quality of life.
How similar studies have performed: Previous studies have shown promise in using rTMS for PTSD, but this specific combination approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veterans of Post-9/11 military conflicts * with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat Exclusion Criteria: * 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 this trial is running
Tallahassee, Florida and 2 other locations
- Florida State University College of Medicine — Tallahassee, Florida, United States (Recruiting)
- Metrocare Services of Dallas — Addison, Texas, United States (Recruiting)
- The University of Texas at Dallas — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: John Hart, Jr., MD — The University of Texas at Dallas
- Study coordinator: Elizabeth "Ellen" Morris, PhD
- Email: neurolab@utdallas.edu
- Phone: 214-883-3171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.