Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE - Heimanwendung Der Transkraniellen Gleichstromstimulation Zur Behandlung Der Chronischen Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Usability for the patients
研究概览
简要总结
It is a one-arm open-label interventional study with transcranial direct current stimulation in an remote home-based setting with the aims to evaluate the feasibility (usability of the device, compliance of patients, usability of the teletherapy), the effectiveness (clinical ratings) and the compatability of this intervention in 20 patients with myalgic encephalomyelitis/chronic fatigue syndrome.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ME/CFS diagnosis according to the Canadian Consensus Criteria
- •residence near Regensburg and mother language German
- •written informed consent
- •stable medication if possible
排除标准
- •contraindications for transcranial direct current stimulation
- •certain neurological conditions as assessed by study physician
- •participation in another study
- •pregnancy and lactation period
研究组 & 干预措施
active treatment
2mA of tDCS for 20 min every weekday for six weeks
干预措施: home-based transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
Usability for the patients
时间窗: 6 weeks
Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire \[1-7, 26 items, the higher the better\]
Usability for the handlers/clinicians
时间窗: 6 weeks
Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire \[1-7, 26 items, the higher the better\]
Number of days out of 30 the patients used the device
时间窗: 6 weeks
Number of days out of 30 the patients used the device
Number of patients who completed the treatment regularly
时间窗: 6 weeks
Number of patients who completed the treatment regularly
Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale
时间窗: 6 weeks
Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale (fatigue scale; 0-33; the lower the better)
Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score
时间窗: 6 weeks
Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score (fatigue scale; 0-100; the higher the better)
Number of responders according the the clinical global impression change score for patients in the per protocol analysis
时间窗: 6 weeks
Number of responders according the the clinical global impression change score for patients in the per protocol analysis (range: 1-7; the lower the better)
次要结局
- digital span(18 weeks)
- Major Depression Inventory(18 weeks)
- numeric analogue scale pain(18 weeks)
- Clinical Global Impression change(18 weeks)
- d2 test(18 weeks)
- Bell score(18 weeks)
- World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)(18 weeks)
- Pittsburgh sleep quality index(18 weeks)
- Chalder fatigue scale(18 weeks)
研究者
Berthold Langguth, MD, Ph.D.
Clinical Professor, MD, Ph.D.
University of Regensburg