NCT03932773 · The University of Texas at Dallas
Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
What this study is about
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.
View original scientific 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.
Interventions
DEVICE
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.
DEVICE
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.
BEHAVIORAL
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 measures
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
Evaluation of treatment group differences on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 6 months after the 12-week interventions. Weathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, \& Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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,
- 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
Where
- Tallahassee, Florida
- Addison, Texas
- Dallas, Texas
Collaborators
University of Texas Southwestern Medical Center, Johns Hopkins University, Metrocare Services of Dallas, Florida State University
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 22, 2025 · Source of record for eligibility and locations