Modulation of Post-COVID-19 Fatigue Using Transcranial Direct Current Stimulation. Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change in Fatigue
研究概览
简要总结
Fatigue is common and disabling in patients with post-COVID syndrome. There is no treatment available at this moment, and fatigue has important consequences. The main aim of this study is to evaluate the changes in the severity of fatigue using non-invasive neuromodulation in patients with post-COVID condition. This is a randomized, parallel, double-blind, placebo-controlled clinical trial using transcranial direct current stimulation. Secondary aims include changes in cognition, depression, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COVID-19 with PCR-confirmation.
- •Fatigue linked to COVID-19
- •No diagnosis of neurological, psychiatric or medical disorder with potential impact on fatigue.
排除标准
- •Stroke before COVID-19
- •History of traumatic brain lesion or central nervous system infection previous to COVID-19
- •Radiotherapy or chemotherapy for cancer
- •Severe sensorial deficits
- •Drugs or uncontrolled medical disorder with potential impact on fatigue.
- •History of abuse of alcohol or other toxics.
- •Any contraindication for tDCS (metallic implants, brain devices, pacemakers, head injuries).
研究组 & 干预措施
Active tDCS
Transcranial current direct stimulation. 8 days.
干预措施: Active tDCS (Device)
Sham tDCS
Sham transcranial current direct stimulation. 8 days.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Change in Fatigue
时间窗: 2 weeks
Modified Fatigue Impact Scale (MFIS)
次要结局
- Change in cognition(2 weeks)
- Change in depressive symptoms(2 weeks)
- Change in quality of life(2 weeks)
研究者
Jordi A Matias-Guiu
PhD MD
Hospital San Carlos, Madrid