Effects of Repetitive Transcranial Magnetic Stimulation on the Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 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
Transcranial magnetic stimulation involves the use of alternating magnetic fields to stimulate neurons in the brain.To date, several studies have focused on the use of TMS in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of rTMS with cross-over design.
详细描述
Background:Repetitive transcranial magnetic stimulation (rTMS) 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 high-frequency rTMS in DOC.
Method:In this randomised,sham-controlled study,real or sham 20 Hz rTMS were applied to the left primary motor cortex (M1) of participants with disorders of consciousness for 5 consecutive days . Evaluations were blindly performed at baseline, immediately after the end of the 5-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG.
Hypothesis
Real rTMS can be an effective awakening method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ages 14 to 65 years old;
- •no centrally acting drugs;
- •no neuromuscular function blockers and no sedation within the prior 24 hours; 4.periods of eye opening (indicating preserved sleep-wake cycles);
- •5.DOC patients, including vegetative state and minimally consciousness state.
排除标准
- •History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
- •with a contraindication for rTMS
研究组 & 干预措施
real-sham
the group first received real rTMS,then sham one.
干预措施: rTMS (Other)
sham-real
the group first received sham rTMS,then real one.
干预措施: rTMS (Other)
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 5-day 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 5-day treatment (T1), 1 week later (T2))