Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Frequency of treatment-emergent adverse events [safety and tolerability]
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind study to transcranial direct current stimulation
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Classification criteria - EULAR/ACR 2017
- •Classification critera - Connors et al.
排除标准
- •Neoplasia
- •Using heart pacemarker
- •Using visceral metalic clips
- •Infections (HIV, HTLV-1, Hepatitis, etc)
- •Pregnance
- •Previous historical of convulsions or epilepsies
结局指标
主要结局
Frequency of treatment-emergent adverse events [safety and tolerability]
时间窗: After 300 days after last stimulation section
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Frequency of treatment-emergent advser events
时间窗: After 30 minutes of intervention
Frequency of disease relapses (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
次要结局
- Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)(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(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(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)(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)(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(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(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)(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(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)(Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section)
研究者
Samuel Katsuyuki Shinjo, PhD
Professor, PhD
University of Sao Paulo