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

Last updated: October 23, 2024
Sponsor: The University of Texas at Dallas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

Cognitive Processing Therapy

Active rTMS

Sham rTMS

Clinical Study ID

NCT03932773
18-123
CDMRP-BA160594
  • Ages 18-60
  • All Genders

Study 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

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

Exclusion Criteria:

  • current enrollment in an acute experimental treatment for PTSD or trauma-focusedpsychotherapy treatment

  • PTSD-inducing trauma exposure occurring within the last 3 months prior topre-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 thatputs 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 seizurethreshold

  • pregnant or nursing

  • metal fragments in the head, or any metal objects in or near the head that cannot besafely removed

  • We will screen for a history of traumatic brain injury and exclude potentialparticipants from the study if they have a history of severe TBI or are at high riskfor seizures.

  • history of seizures

  • non-English speakers because not all of the screening forms, questionnaires, andtests are available in any language except for English

  • cardiac pacemaker, implanted medication pumps of any sort that would increase therisk of rTMS

  • any current medical condition that could preclude being able to safely participatein TMS treatment,

  • use of prescription medication or illegal substances that lower the seizurethreshold

  • previous rTMS

Study Design

Total Participants: 330
Treatment Group(s): 3
Primary Treatment: Cognitive Processing Therapy
Phase:
Study Start date:
May 01, 2019
Estimated Completion Date:
July 31, 2025

Study Description

Using three treatment arms, the study will examine Posttraumatic Stress Disorder (PTSD) symptom reduction when (1) 1 Hz (hertz) repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) is administered prior to each of 12 Cognitive Processing Therapy (CPT) sessions compared to when (2) sham rTMS is administered to the rDLPFC is administered prior to each of 12 CPT sessions and to when (3) 1 Hz rTMS is delivered to rDLPFC alone over 12 sessions.

Veterans with combat-related PTSD will be randomly assigned to one of the three treatment arms. Primary outcome PTSD symptom severity measures, secondary neuropsychological, electroencephalography (EEG), and magnetic resonance imaging (MRI) outcome measures, and prescreening assessments for study contraindicators will be collected prior to being assigned to a treatment arm (i.e., baseline).

Primary outcome PTSD symptom severity measures and secondary neuropsychological outcome measures will be collected twice within the span of the treatment sessions (i.e., sessions 5 and 9) and at three times following treatment competition (i.e., 1-month, 6-months, and 12-months). EEG also will be collected at the 1-month, 6-month, and 12-month assessments, and MRI will be collected at the 6-month and 12-month assessments.

Connect with a study center

  • Florida State University College of Medicine

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

  • James A. Haley Veterans' Hospital

    Tampa, Florida 33612
    United States

    Site Not Available

  • Metrocare Services of Dallas

    Addison, Texas 75001
    United States

    Active - Recruiting

  • The University of Texas at Dallas

    Dallas, Texas 75235
    United States

    Active - Recruiting

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