Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
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: Chronic transcranial direct current stimulation.
- Кому может быть актуально
- Состояния в реестре: Myopathy. 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
- Бразилия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Systemic autoimmune myopathies are rheumatic diseases that affect the striatum skeletal muscles. The transcranial direct current stimulation technique has been frequent, for example, in patients with ischemic stroke or for the optimization of muscular performance in athletes. However, to date, there are no studies evaluating this technique in patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of chronic transcranial direct current stimulation sessions - associated with aerobic exercises - in the patients with systemic autoimmune myopathies.
Подробное описание
Systemic autoimmune myopathies are rheumatic diseases that affect the striatum skeletal muscles. Depending on the clinical, pathophysiological and laboratory characteristics, they may be subdivided into polymyositis, dermatomyositis, antissintetase syndrome, immune-mediated necrotizing myopathy, and among others. Recently, the literature has been presenting better pharmacological treatment options to control these diseases. Despite these advances, this group of diseases still continues to be associated with high morbidity and functional disability, mainly due to the proximal muscular weakness of the scapular and pelvic girdles that may prevent the total recovery of these patients. On the other hand, the association of the transcranial current stimulation technique with motor recovery has been frequent, for example, in patients with ischemic stroke or for the optimization of muscular performance in athletes. However, to date, there are no studies evaluating this technique in patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of chronic transcranial current stimulation session - associated with aerobic exercises - in patients with systemic autoimmune myopathies.
Вмешательства
- Другое Chronic transcranial direct current stimulation
Chronic transcranial direct current stimulation
Первичные конечные точки
- Frequency of treatment-emergent advser events [Срок оценки: After 30 minutes of intervention]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Срок оценки: Before stimulation]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Срок оценки: Immediately after all stimulation section]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Срок оценки: After 30 days after last stimulation section]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Срок оценки: After 60 days after last stimulation section]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Срок оценки: After 90 days after last stimulation section]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Срок оценки: After 300 days after last stimulation section]
Вторичные конечные точки (10)
- Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT) [Срок оценки: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Serum levels of Muscle enzymes [Срок оценки: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Health Assessment Questionnaire (HAQ) [Срок оценки: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Manual Muscle Testing (MMT) [Срок оценки: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Patient Global Activity [Срок оценки: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Physician Global Activity [Срок оценки: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Fatigue Severity Scale [Срок оценки: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Short Form McGill Pain Questionnaire 2 (SF-MPQ-2) [Срок оценки: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Short Physical Performance Battery (SPPB) [Срок оценки: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Timed up and go test [Срок оценки: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
Критерии участия
Критерии включения
- Classification criteria - EULAR/ACR 2017
- Classification critera - Connors et al.
Критерии исключения
- Neoplasia
- Using heart pacemarker
- Using visceral metalic clips
- Infections (HIV, HTLV-1, Hepatitis, etc)
- Pregnance
- Previous historical of convulsions or epilepsies
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
- Двойное слепое
- Основная цель
- Другое
Центры проведения
Бразилия · 1 центр
- Samuel K Shinjo — São Paulo
Публикации
- Misse RG, Dos Santos AM, Borges IBP, Grecco MV, Faria MSMS, da Silva LRS, Correia BL, Kim AWS, Tanaka C, Greve JMD, Baptista AF, Shinjo SK. Impact of Transcranial Direct Current Stimulation in Pain, Fatigue, and Health Quality of Life of Patients with Idiopathic Inflammatory Myopathies: A Randomized, Double-Blind, Sham-Controlled Crossover Clinical Trial. Int J Rheumatol. 2024 Feb 1;2024:1583506. PMID 38332984
Идентификаторы
NCT: NCT04678635 · MYO-HCFMUSP-08