Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI

NCT07715799 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: STUDY00002715HT9425-25-1-0730
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD; Transcranial Direct Current Stimulation (tDCS); Written Exposure Therapy (WET)

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale (CAPS-5)

  The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders v5 (DSM-5) criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Subscale scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of PTSD. Scores range from 0 to 80. Change in score will be reported.

  Baseline to 6 months

• Neurobehavioral Symptom Inventory (NSI)

  The NSI consists of 22 non-specific complaints commonly reported after concussion and is used by clinicians to quantify TBI symptom severity and select symptoms for treatment. The NSI asks the patient to rate each of the symptoms according to how much the symptom has disturbed him/her using a five-point scale. Scores range from 0-88 with a higher score indicating more neurobehavioral symptoms

  Baseline to 6 months

Study Arms (2)

tDCS plus WET treatment

EXPERIMENTAL

Combined use of transcranial direct current stimulation (tDCS) and Written Exposure Therapy (WET) once per week over 5 weeks

Device: Transcranial Direct Current Stimulator; Other: Written Exposure Therapy

Sham plus WET

SHAM COMPARATOR

Sham tDCS plus WET treatment once per week over 5 weeks

Other: Written Exposure Therapy

Interventions

Written Exposure Therapy OTHER

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.

Also known as: WET

Sham plus WET; tDCS plus WET treatment

Transcranial Direct Current Stimulator DEVICE

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.

Also known as: tDCS

tDCS plus WET treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• United States Department of Defense: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Links

• Please follow the link to learn more about this study and ongoing STRONG STAR trials

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Casey Straud, PsyD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey Straud, PsyD

CONTACT

210-562-6742; straud@uthscsa.edu

Amanda Flores, BS

CONTACT

210-562-6726; floresa13@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: tDCS dosing will be double-blind so that none of the participants, investigators, and study staff (including study coordinators, research assistants, assessors, clinicians, clinical supervisors) who interact with participants will know the randomized condition. Only team member(s) who manage randomization will know the randomized dose condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two arm, double-blind, randomized clinical trial

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): May 30, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: July 20, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the conclusion of the study (approximately 48 months).
• Access Criteria: Requests related to the access should be submitted to the STRONG STAR Repository.

Locations

US (1)