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Идёт набор NCT06434766

Multicenter iTBS Neuromodulation for PTSD Treatment

Без фазы С лечением Posttraumatic 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: sham stimulation, intermittent theta-burst stimulation (iTBS).
Кому может быть актуально
Состояния в реестре: Posttraumatic Stress Disorder. Базовые параметры: 18 лет — 65 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
Китай
Следующий шаг
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Официальное название

A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment

Обзор

The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. The primary outcome measure includes changes in PTSD symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social/occupation functioning and functional connectivity of the brain.

Подробное описание

The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex as adjunct treatment for PTSD patients.

Compared to traditional repetitive transcranial magnetic stimulation (rTMS), iTBS strategy usually delivers large amounts of pulses in a shorter time period, and its equal efficiency has been demonstrated in several psychiatric disorders such as major depressive disorder (MDD). Through this adequately randomized and sham-controlled study of iTBS for PTSD, this work will provide an alternative and potentially more potent stimulation target for clinical PTSD treatment. This study will also provide a comprehensive assessment of this treatment strategy towards improvements in symptoms, quality of life and brain functioning in PTSD.

The ultimate goal of this study is to develop a non-invasive brain stimulation approach targeting a novel site for alleviating symptoms and improving life quality for PTSD patients.

Вмешательства

  • Устройство sham stimulation
    sham theta-burst transcranial magnetic stimulation
  • Устройство intermittent theta-burst stimulation (iTBS)
    intermittent theta-burst transcranial magnetic stimulation

Первичные конечные точки

  • Change in PTSD Symptom Severity [Срок оценки: Baseline and 4 weeks after finishing treatment]
Вторичные конечные точки (6)
  • Change in PTSD Symptom Severity [Срок оценки: Baseline, 10 times treatment, 20 times treatment, 2 weeks after finishing treatment and 8 weeks after finishing treatment]
  • Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score [Срок оценки: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment]
  • Change in The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) Score [Срок оценки: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment]
  • Change in The Personal Social Performance (PSP) scale [Срок оценки: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment]
  • change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) [Срок оценки: Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment]
  • Change in neural activity pattern and functional connectivity of the brain based on fMRI [Срок оценки: Baseline, 20 times treatment, 4 weeks after finishing treatment]

Критерии участия

Критерии включения

  • Aged between 18 to 65 years old
  • Right handedness
  • Have a diagnosis of PTSD meeting DSM-5 criteria
  • CAPS-5 score>35
  • Under stable medication for at least four weeks
  • Capable of independently reading and understanding study materials and providing informed consent.

Критерии исключения

  • Current (or past if appropriate) significant neurological or medical disorder, or lifetime history of 1) seizure disorder; 2) primary or secondary CNS tumors; 3) stroke; or 4) cerebral aneurysm.
  • Primary psychotic disorder, bipolar I disorder, major depressive disorder, or personality disorders
  • Lifetime history of attempted suicide or HAMD-17 suicide item (item 3) ≥ 3 points
  • Implanted device (deep brain stimulation) or metal in the brain; a pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos if choose to do fMRI
  • Previous experience of rTMS
  • Pregnancy/lactation, or planning to become pregnant during the study
  • Current under psychological or other physical treatments

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 5 центров
  • Shanghai Mental Health Center — Шанхай
  • First Affiliated Hospital of Anhui Medical University — Ханчжоу
  • Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу
  • The Affiliated Kangning Hospital of Ningbo University — Ningbo
  • Tongji Hospital of Tongji University — Шанхай

Идентификаторы

NCT: NCT06434766 · yan2024-0108

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗