Recruiting

PTSD

Sponsor:

The University of Texas at Dallas

Code:

NCT03932773

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Active rTMS

Sham rTMS

Cognitive Processing Therapy

Study Details

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.

Conditions

Post Traumatic Stress Disorder

Study ID

NCT03932773

Start date

May 1, 2019

Status verified date

Aug, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham rTMS + CPT

30 minutes of sham repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) prior to each Cognitive Processing Therapy (CPT) session

active comparator: Active rTMS + CPT

30 minutes of 1 Hz rTMS to rDLPFC prior to each CPT session

active comparator: Active rTMS Alone

30 minutes of 1 Hz rTMS to rDLPFC at 1 session per week over 12 weeks

Interventions

Active rTMS

A Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be used to deliver 1 hertz (Hz) stimulation to right dorsolateral prefrontal cortex (rDLPFC) at 110% of a participant's rTMS motor threshold. The device passes electric current through a coil generating an alternating magnetic field. When positioned over the skull, the changing magnetic field causes electromagnetic inducted current flow in brain regions subjacent to the coil. Magnetic pulses (1.5-2.0 Tesla) lasting 100-300 microseconds at 1 Hz will be used.

Motor threshold will be defined by the TMS intensity to right motor region required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time.

Sham rTMS

A Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be paired with sham coil. The sham coil will induce electrical current flow in the tissue above the skull but will not induce current flow in brain tissue. The sham coil will be placed over the right prefrontal scalp region to target current flow in rDLPFC. Magnetic pulses lasting for 100-300 microseconds at 1 Hz will be used.

For consistency across the rTMS conditions, motor threshold in the sham condition also will be determined by positioning the active rTMS coil over the right motor region and identifying the stimulation intensity required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time.

Cognitive Processing Therapy

Cognitive Processing Therapy (CPT) is an evidenced based, trauma-focused treatment for Posttraumatic Stress Disorder (PTSD). CPT is a recommended form of treatment in the Veterans Administration - Department of Defense Clinical Practice Guideline for PTSD. The CPT manual delineates the agenda for each of 12 sessions (60 minutes per session): 1) Introduction to CPT and Patient Education regarding PTSD, 2) Meaning of the Trauma, 3) Identification of Thoughts and Feelings related to the Trauma, 4) Remembering the Trauma, 5) Identification of Stuck points, 6) Challenging Questions about the Trauma, 7) Dysfunctional/Maladaptive Thinking patterns related to the Trauma, 8) Safety Issues, 9) Trust Issues, 10) Power and Control Issues, 11) Self-Esteem Issues, and 12) Intimacy Issues.

Primary outcome measure

  • Treatment group differences in change from baseline to 6-months post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score [ Time Frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment ]

Central Contacts and Locations

Central contacts

Elizabeth "Ellen" Morris, PhD

214-883-3171neurolab@utdallas.edu

Jill Ritter, BS

972-883-3171neurolab@utdallas.edu

Locations

Florida State University College of Medicine

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

FSU Neuromodulation

850-644-2824FSUN@med.fsu.edu

Metrocare Services of Dallas

Recruiting

Addison, Texas, United States, 75001

Contacts

Steven A Cohen Military Family Clinic at Metrocare

469-680-3500MFC@MetrocareServices.org

The University of Texas at Dallas

Recruiting

Dallas, Texas, United States, 75235

Contacts

Celia Higginbotham

972-883-3171neurolab@utdallas.edu

Crista Thyvelikakath, MA

972-883-3171neurolab@utdallas.edu

More Information

Sponsor

The University of Texas at Dallas

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • PTSD
  • post-traumatic stress disorder
  • military-related PTSD
  • CPT
  • cognitive processing therapy
  • rTMS
  • repetitive transcranial magnetic stimulation
  • combat
  • combat-related PTSD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas at Dallas on 2026-08-20.