Effects of Transcranial Direct Current Stimulation on the Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- the JFK Coma Recovery Scale-Revised (CRS-R) scale
研究概览
简要总结
To date, several studies have focused on the use of transcranial direct current stimulation(tDCS) in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of tDCS.
详细描述
Background:tDCS was supposed as an experimental approach to disorders of consciousness treatment. Its therapeutic effects have been variously documented.
Objective
The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of highfrequency tDCS in DOC.
Method:In this double-blind, randomized controlled trial,real or sham tDCS were applied to the left dorsolateral prefrontal (DLPF) cortex of participants with disorders of consciousness for two weeeks. Evaluations were blindly performed at baseline, immediately after the end of the 14-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of DOC
- •Ages 14 to 65 years old
- •No centrally acting drugs
- •No neuromuscular function blockers and no sedation within the prior 24 hours;
排除标准
- •History with nervous or spirit disorders, or some other serious diseases
- •A contraindication for tDCS
结局指标
主要结局
the JFK Coma Recovery Scale-Revised (CRS-R) scale
时间窗: at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).Investigators observed the changes from baseline to the end of stimulation.
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
次要结局
- EEG data ( electrophysiological parameters)(at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).)