GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise Zur Medbo (Transcranial Direct Current Stimulation and Depression: Home Treatment)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Usability for the handlers/clinicians
研究概览
简要总结
In this one-armed study the feasibility and effectiveness of a home treatment with transcranial direct currect stimulation in depression will be investigated.
详细描述
In this one-armed study at least 10 patients with depression will be included who will get treatment with transcranial direct currect stimulation at home. One visit in the hospital before and one visit after the treatment are necessary. The correct application of the device by the patients will be ensured by video counseling and monitoring. Treatment will last six weeks with 2 mA applied every working day for 20min with prefrontal montage.
Aim of the study is the evaluation of the feasibility of this home treatment (usability of the device, compliance of patients, usability of the video contacts), the effectiveness (clinical ratings) and the tolerability of this treatment.
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
- •depressive episode according to ICD-10
- •moderate depression according to clinical impression or Hamilton depression rating scale
- •gender: all sexes
- •age: 18-70 years
- •stable medication if possible
- •no or stable treatment of depression
- •residence in Germany and mother language German
- •written informed consent
排除标准
- •contraindications for transcranial direct current stimulation
- •neurological conditions
- •participiation in another study
- •pregnancy and lactation period
结局指标
主要结局
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 \[1-7, 26 items, the higher the better\] and open feedback
Compliance 1 (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
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 \[1-7, 26 items, the higher the better\] and open feedback
Compliance 2 (Number of patients who completed the treatment regulary)
时间窗: 6 weeks
Number of patients who completed the treatment regulary
Efficiancy 1 (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
Stability of effects 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items))
时间窗: 18 weeks
Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)
Efficiancy 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items))
时间窗: 6 weeks
Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)
Stability of effects 1 (Number of responders according the the clinical global impression change score)
时间窗: 18 weeks
Number of responders according the the clinical global impression change score
次要结局
- Pittsburgh sleep quality index(18 weeks)
- Depression anxiety stress scale (DASS)(18 weeks)
- Hamilton depression rating scale(18 weeks)
- Major Depression Inventory(18 weeks)
- WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)(18 weeks)
- Personality styles and disorder inventory(18 weeks)
- Clincial Global Impression change(18 weeks)
研究者
Berthold Langguth, MD, Ph.D.
Clinical Professor, MD, Ph.D.
University of Regensburg