NCT03932773 Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
| NCT ID | NCT03932773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas at Dallas |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2019-05-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 330 participants in total. It began in 2019-05-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
John Hart, Jr., MD
PRINCIPAL INVESTIGATOR
The University of Texas at Dallas
Frequently Asked Questions
Who can join the NCT03932773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03932773 currently recruiting?
Yes, NCT03932773 is actively recruiting participants. Contact the research team at neurolab@utdallas.edu for enrollment information.
Where is the NCT03932773 trial being conducted?
This trial is being conducted at Tallahassee, United States, Addison, United States, Dallas, United States.
Who is sponsoring the NCT03932773 clinical trial?
NCT03932773 is sponsored by The University of Texas at Dallas. The principal investigator is John Hart, Jr., MD at The University of Texas at Dallas. The trial plans to enroll 330 participants.