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

RecruitingNA

Sponsor: The University of Texas at Dallas

Conditions: Post Traumatic Stress Disorder

Interventions: Active rTMS, Sham rTMS, Cognitive Processing Therapy

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (3)

Tallahassee, Florida, United States
Addison, Texas, United States
Dallas, Texas, United States