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Набор скоро начнётся NCT07715799

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

Без фазы С лечением Post Traumatic Stress Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcranial Direct Current Stimulator, Written Exposure Therapy.
Кому может быть актуально
Состояния в реестре: Post Traumatic Stress Disorder. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A Randomized Clinical Trial Using Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство 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.
  • Другое 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.

Первичные конечные точки

  • Clinician Administered PTSD Scale (CAPS-5) [Срок оценки: Baseline to 6 months]
  • Neurobehavioral Symptom Inventory (NSI) [Срок оценки: Baseline to 6 months]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The University of Texas Health Science Center at San Antonio — San Antonio

Идентификаторы

NCT: NCT07715799 · STUDY00002715 · HT9425-25-1-0730

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗