Acute 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 a heterogeneous group of rheumatic diseases that primarily affect the 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 acute transcranial current stimulation session in patients with systemic autoimmune myopathies.
详细描述
Currently, there are no studies evaluating the transcranial current stimulation 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 acute transcranial direct current stimulation session 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 current stimulation
入排标准
- 年龄范围
- 18 Years 至 80 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.
- •Objective muscle limb weakness
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
研究组 & 干预措施
Transcranial direct current stimulation
Transcranial direct current stimulation session: the energy of the anode (transcranial current stimulation) will have as its source a battery-powered DC generator and will be exerted by two electrodes measuring 5x7cm and attached to the head. The electrodes will be located of the primary motor cortex. The electrode with positive charge (anode) will be positioned at contralateral to the dominant limb and the negative charged electrode will be positioned in the supraorbital region ipsilateral to the dominant limb. The active current of direct transcranial stimulation will be applied with the intensity of electric current of 2mA and density of 0.057 mA/cm2 with duration of 20 minutes. During the session, patients will remain seated. Number of sessions: three times, once per day.
干预措施: Transcranial direct current stimulation session. (Other)
Placebo
This group will not receive a transcranial direct current stimulation session.
干预措施: Transcranial direct current stimulation session. (Other)
结局指标
主要结局
Frequency of treatment-emergent adverse events [safety and tolerability]
时间窗: After 8 weeks of transcranial stimulation.
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Frequency of treatment-emergent adverse events [safety and tolerability]
时间窗: After 30 minutes of transcranial stimulation.
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
次要结局
- Serum levels of Muscle enzymes(4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.)
- Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)(3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.)
- Health Assessment Questionnaire (HAQ)(3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation)
- Manual Muscle Testing (MMT)(4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.)
- Patient Global Activity(4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.)
- Physician Global Activity(4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.)
研究者
Samuel Katsuyuki Shinjo, PhD
Professor, PhD
University of Sao Paulo