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Идёт набор NCT07401225

TMS for PTSD in Youth

Без фазы С лечением Post Traumatic Stress Disorder (PTSD)

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: MagPro R30 with robotic arm.
Кому может быть актуально
Состояния в реестре: Post Traumatic Stress Disorder (PTSD). Базовые параметры: 12 лет — 20 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

Transcranial Magnetic Stimulation as Treatment for Persistent PTSD in Texas Youth

Обзор

The purpose of this study is to test whether transcranial magnetic stimulation, or TMS, is an acceptable and helpful treatment for ongoing symptoms of posttraumatic stress syndrome disorder (PTSD) in 12-20 year olds. Ongoing PTSD refers to symptoms that continue after completing trauma-focused psychotherapy. About 1 in 4 patients need additional help to overcome PTSD after completing psychotherapy. Currently, scientists do not know the best way to help adolescents with persistent PTSD, and this study will test TMS as a possible treatment, and hopefully lead to future studies including more people.

Подробное описание

Trauma is a common occurrence among youth. Almost 60% of American youths experience a traumatic event before age 18, such as physical or sexual abuse, sudden loss of caregivers, or witnessing violence in the community or the home. Distress after a significantly traumatic event is to be expected, but for some youths, symptoms of posttraumatic stress disorder (PTSD) linger for months or years, and can become chronic if left untreated. Symptoms of PTSD can include upsetting memories, avoidance of reminders, and emotional numbing, and other symptoms. These symptoms can create difficulties for family relationships, friendships, and schoolwork. Currently, the most effective treatment for PTSD is talk therapy (trauma-focused psychotherapy). However, sometimes young people continue to have symptoms of PTSD after completing talk therapy, and it is currently not known the best way to help with these persistent symptoms.

In this study, the total length of time participants will be involved in the study is about 16-weeks. During that time, participants will be asked to attend approximately 6 research visits and 10 treatment visits, for a total of 16 visits. The 6 research visits include a screening visit, an interview visit, 2 MRI visits, and 2 follow-up visits. The screening, interview, and follow-up visits can be completed virtually, over zoom. The study will include 2 MRI visits and 10 treatment visits. Virtual follow-up visits will be conducted 1 and 3 months after completion of treatment and will include interviews and questionnaires about participants symptoms.

Вмешательства

  • Устройство MagPro R30 with robotic arm
    TMS will be delivered to the right anterior dorsolateral frontal cortex. The accelerated protocol consists of 1,800 TMS pulses per session, delivered at intensity ranges designed to deliver depth-corrected E-fields of 80-95 volts/meter. The exact intensity will be determined when the participant's treatment plan is developed. Once a patient's TMS treatment plan has been created, it will be used for every treatment session for that participant.

Первичные конечные точки

  • Side Effects of TMS treatment [Срок оценки: Day 1 of treatment through Day 30]
  • Number of Adverse Events [Срок оценки: Day 1 of treatment through Day 30]
  • Completion rate of Treatment [Срок оценки: Day 1 of treatment through Day 30]
Вторичные конечные точки (2)
  • Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)(CAPS-5) [Срок оценки: Baseline to 90 days]
  • Assessment of Depression using Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline to Day 30]

Критерии участия

Критерии включения

  • Males and females; Age 12-20
  • Have previously completed at least 9 sessions of trauma-focused therapy in our clinical trial or in the community
  • Have current self-reported symptom score of 20 or greater on the UCLA PTSD Reaction index
  • Willing to attend 10 TMS treatment sessions within a 30-day period
  • Fluent in English

Критерии исключения

  • History of seizures
  • History of head injury with loss of consciousness and concussive sequelae
  • Brain abnormality such as tumor or other observable abnormality
  • Currently receiving psychotherapy or TMS treatment
  • Currently pregnant
  • MRI contraindications (metal in body, orthodontic braces)
  • Diagnosis of bipolar 1 or a psychotic disorder

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UT Health Department of Psychiatry — San Antonio

Идентификаторы

NCT: NCT07401225 · STUDY00002052 · NECMHR02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗