Long-term Effect of 20 Sessions of Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Double Blind Sham Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in the CRS-R total score
研究概览
简要总结
In this multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected.
This research will 1) determine whether long-term behavioral recovery can be promoted with tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe brain injury and its potential application in rehabilitation.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CNS medication stable for at least a week
- •Stable diagnosis (no diagnosis change based on 2 CRS-R performed within 1 week).
- •Between 3 and 24 months post injury
- •Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC)
排除标准
- •Craniotomies encompassing the frontal region (electrodes location)
- •VPS under the stimulated area (prefrontal cortex)
- •Pacemaker
- •Metallic cerebral implant
- •Severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).
结局指标
主要结局
Change in the CRS-R total score
时间窗: 4 weeks
Improvement of the CRS-R total score after the end of the anodal session.
次要结局
未报告次要终点
研究者
Aurore Thibaut
Principal Investigator
University of Liege