Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Direct Current Stimulator, Written Exposure Therapy.
- Who it may be relevant to
- Registry conditions: Post Traumatic Stress Disorder. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Clinical Trial Using Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI
Overview
In this study, the investigators are evaluating whether transcranial direct current stimulation (tDCS), a brain stimulation technique, can be combined with Written Exposure Therapy (WET), a standard talk therapy for posttraumatic stress disorder (PTSD) to improve treatment response and improve symptom of traumatic brain injury (TBI). After consenting to be in the study, participants will be asked to complete a baseline assessment of your psychological and physical health that will determine whether you are able to participate in the study. Following the baseline, you will be randomly assigned to receive tDCS or a sham/placebo. Everyone will also participate in 5 weekly WET psychotherapy sessions for 5 consecutive weeks. The first appointment will be 90 minutes and the subsequent appointments will be 60 minutes. tDCS or sham/placebo will occur during the writing portion of the session. All participants will also be asked to complete 1-, 3-, and 6-month posttreatment follow-up assessments.
Detailed description
The primary objective of this study is to build upon a previously conducted pilot study and formally test the synergistic effects of tDCS with WET for PTSD in military service members and veterans with TBI. Secondary objectives are to evaluate improvements in persistent PCS of TBI, examine tDCS effects on physiological outcomes of extinction learning, and explore the dynamic timing of PTSD and PCS improvements to better understand how tDCS treatment influences these comorbid conditions.
Aim 1: To conduct a 2-arm, double-blind, sham-controlled randomized clinical trial of active tDCS with WET vs. sham tDCS with WET for PTSD in military service members and veterans with TBI (N = 150).
Aim 2: To evaluate physiological outcomes during the writing exposure portion of WET as potential mechanisms of change in the treatment of PTSD.
Interventions
- Device Transcranial Direct Current Stimulator
tDCS will be administered using a Soterix 1x1 Transcranial Direct Current Stimulator. The intervention for this study will compare five, 30 minute sessions of active tDCS (2.0mA) targeting the dorsolateral prefrontal cortex (DLPFC) vs. a sham condition (0.0mA) for the treatment of PTSD in a sample of military personnel with mild to moderate TBI. - Other Written Exposure Therapy
Participants in both treatment conditions will receive 5 weekly sessions of WET delivered as standard of care for PTSD. WET is an evidence-based, trauma-focused therapy for PTSD that is recommended by the VA/DoD Clinical Practice Guidelines for PTSD that is brief and effective.
Primary outcome measures
- Clinician Administered PTSD Scale (CAPS-5) [Time frame: Baseline to 6 months]
- Neurobehavioral Symptom Inventory (NSI) [Time frame: Baseline to 6 months]
Eligibility criteria
Inclusion criteria
- U.S military service member or veteran (18-70 years old)
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5-R)
- History of mild to moderate Traumatic Brain Injury (TBI)
- Able to speak, read, and write in English (due to assessment measures and writing intervention)
Exclusion criteria
- TBI that occurred within the past three months prior to the baseline assessment
- History of significant intracranial pathology (e.g., severe TBI)
- History of major neurological disorder (e.g., epilepsy, dementia)
- Metallic objects other than dental appliances/fillings above the shoulders.
- Electronic implants that could be susceptible to electrical current (e.g., cardiac pacemaker)
- History of skin condition at site of stimulation (e.g., psoriasis)
- Current suicidal ideation severe enough to warrant immediate attention
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization
- Current substance use requiring stabilization or hospitalization
- Change in anti-convulsive or benzodiazepine medication regimen in past month.
- History of adverse effects to previous noninvasive brain stimulation.
- Concurrent engagement in another noninvasive brain stimulation or trauma focused psychotherapy.
- Currently pregnant or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center at San Antonio — San Antonio
Identifiers
NCT: NCT07715799 · STUDY00002715 · HT9425-25-1-0730