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

Description

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.

Conditions

Post Traumatic Stress Disorder

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Post Traumatic Stress Disorder
Intervention / Treatment

-

Contacts and Locations

Tallahassee

Florida State University College of Medicine, Tallahassee, Florida, United States, 32308

Addison

Metrocare Services of Dallas, Addison, Texas, United States, 75001

Dallas

The University of Texas at Dallas, Dallas, Texas, United States, 75235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas at Dallas,

John Hart, Jr., MD, PRINCIPAL_INVESTIGATOR, The University of Texas at Dallas

F. Andrew Kozel, MD, PRINCIPAL_INVESTIGATOR, Florida State University, College of Medicine

John Burruss, MD, PRINCIPAL_INVESTIGATOR, Metrocare Services of Dallas

Study Record Dates

2025-07-31