Transcranial Direct Current Stimulation in Post-Acute COVID-19 Patients With Systemic Autoimmune Rheumatic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 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
Some patients develop "Post-acute COVID-19 syndrome," in which they experience persistent symptoms after recovering from the acute phase of COVID-19 infection. This syndrome may be more significant in patients with systemic autoimmune rheumatic diseases (SARDs) who have been suffering from several symptoms associated to SARDs, such as myalgia, fatigue, and general pains.
The transcranial direct current stimulation (tDCS) technique has been frequent, for example, to relieve fatigue and general pains in general population. However, to date, there are no studies evaluating this technique in ARD patients with post-acute COVID-19; therefore, the main objective of the opened study is to evaluate the safety and efficacy of the application of acute tDCS in ARD patients with post-acute COVID-19.
详细描述
Currently, there are no studies evaluating the tDCS technique in ARD patients with post-acute COVID-19; therefore, the main objective of the present study is to evaluate the safety and efficacy of the application of acute tDCS in these specific patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with well-defined ARDs (rheumatoid arthritis, sclerosis systemic, Sjögren syndrome, spondyloarthritis, systemic lupus erythematosus, systemic vasculitis, and systemic autoimmune myopathies)
- •Fatigue or general pains.
排除标准
- •Neoplasia, using heart pacemarker, using visceral metalic clips, infections (HIV, HTLV-1, hepatitis), 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: [Time Frame: After 60 days of transcranial stimulation.]
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
次要结局
- Health Assessment Questionnaire (HAQ)([Time Frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) one and (c) two months after stimulation])
研究者
Samuel Katsuyuki Shinjo, PhD
Professor, PhD
University of Sao Paulo