[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07715799":3,"trial-entities:NCT07715799":94,"trial-summary:NCT07715799":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":47,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":76,"overall_officials":86,"references":89,"see_also_links":90},"NCT07715799","STUDY00002715","Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI","A Randomized Clinical Trial Using Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI","NOT_YET_RECRUITING","2030-09-01","2026-06","2026-07-20","2026-09-30","The University of Texas Health Science Center at San Antonio","OTHER",true,"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).\n\nAfter 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\u002Fplacebo. 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\u002Fplacebo 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.","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.\n\nAim 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).\n\nAim 2: To evaluate physiological outcomes during the writing exposure portion of WET as potential mechanisms of change in the treatment of PTSD.",[19],"Post Traumatic Stress Disorder",[21,22,23],"PTSD","Transcranial Direct Current Stimulation (tDCS)","Written Exposure Therapy (WET)","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},150,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"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.",[37],"tDCS plus WET treatment",[39],"tDCS",{"type":14,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"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\u002FDoD Clinical Practice Guidelines for PTSD that is brief and effective.",[44,37],"Sham plus WET",[46],"WET",[48,52],{"measure":49,"description":50,"timeFrame":51},"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\u002Fincapacitating) 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",{"measure":53,"description":54,"timeFrame":51},"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\u002Fher using a five-point scale. Scores range from 0-88 with a higher score indicating more neurobehavioral symptoms",[],"ALL","18 Years","70 Years",false,{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"Inclusion Criteria:\n\n1. U.S military service member or veteran (18-70 years old)\n2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5-R)\n3. History of mild to moderate Traumatic Brain Injury (TBI)\n4. Able to speak, read, and write in English (due to assessment measures and writing intervention)\n\nExclusion Criteria:\n\n1. TBI that occurred within the past three months prior to the baseline assessment\n2. History of significant intracranial pathology (e.g., severe TBI)\n3. History of major neurological disorder (e.g., epilepsy, dementia)\n4. Metallic objects other than dental appliances\u002Ffillings above the shoulders.\n5. Electronic implants that could be susceptible to electrical current (e.g., cardiac pacemaker)\n6. History of skin condition at site of stimulation (e.g., psoriasis)\n7. Current suicidal ideation severe enough to warrant immediate attention\n8. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization\n9. Current substance use requiring stabilization or hospitalization\n10. Change in anti-convulsive or benzodiazepine medication regimen in past month.\n11. History of adverse effects to previous noninvasive brain stimulation.\n12. Concurrent engagement in another noninvasive brain stimulation or trauma focused psychotherapy.\n13. Currently pregnant or breastfeeding.",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":13,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"San Antonio","Texas","78229","United States",{"lat":74,"lon":75},29.42412,-98.49363,[77,82],{"name":78,"role":79,"phone":80,"email":81},"Casey Straud, PsyD","CONTACT","210-562-6742","straud@uthscsa.edu",{"name":83,"role":79,"phone":84,"email":85},"Amanda Flores, BS","210-562-6726","floresa13@uthscsa.edu",[87],{"name":78,"affiliation":13,"role":88},"PRINCIPAL_INVESTIGATOR",[],[91],{"label":92,"url":93},"Please follow the link to learn more about this study and ongoing STRONG STAR trials","https:\u002F\u002Fwww.strongstar.org\u002Ftreatment\u002F",{"nct_id":4,"conditions":95,"biomarkers":98},[96,97],"Post-Traumatic Stress Disorder","Traumatic Encephalopathy",[],{"nct_id":4,"found":15,"summary":100,"prompt_version":110},{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is a randomized, double-blind, sham-controlled study with 150 participants. You would be randomly assigned to one of two groups.","completed","Noninvasive Brain Stimulation and Talk Therapy for PTSD in Military Personnel","This study is looking at whether combining transcranial direct current stimulation (tDCS), a type of noninvasive brain stimulation, with Written Exposure Therapy (WET), a standard talk therapy for PTSD, can better help military service members and veterans with Post Traumatic Stress Disorder (PTSD) and a history of Traumatic Brain Injury (TBI). You would be randomly assigned to receive either active tDCS or a sham (inactive) tDCS, along with 5 weekly sessions of WET. Researchers will measure your PTSD symptoms using the Clinician Administered PTSD Scale (CAPS-5) and other symptoms using the Neurobehavioral Symptom Inventory (NSI) to see if the treatment helps. To join, you must be a U.S. military service member or veteran between 18 and 70 years old, have a PTSD diagnosis and a history of mild to moderate TBI, and be able to speak, read, and write in English.","Your symptoms will be measured from when you start the study up to 6 months later.",141,"You would complete a baseline assessment, then receive 5 weekly, 30-minute tDCS sessions and 5 weekly WET sessions. Your symptoms will be measured from baseline up to 6 months.","Not stated in the trial record.",[41],"v2"]