Asia Coma Electrical Stimulation Trial: an Asian Multicenter Randomized Controlled Trial to Assess the Efficacy and Safety of Right Median Nerve Stimulation for Traumatic Coma
试验速览
- 阶段
- 3 期
- 入组人数
- 360
- 主要终点
- Proportion of patients returning consciousness
研究概览
简要总结
This study is a prospective multicenter randomized controlled trial from Asian countries to compare the effect and safety of right median nerve stimulation versus traditional treatment for comatose patients at the early stage following traumatic brain injury.
详细描述
Traumatic brain injury (TBI) is a leading cause of mortality and morbidity and one of the greatest unmet needs in public health. The most severe injury can lead to a poor outcome and prolonged coma of the victims. It is estimated that ten to fifteen percent of the severe TBI patients are discharged in a prolonged coma or a vegetative state. However, no treatment measure to data has been proven robustly to alter the pace of recovery or improve neurological outcome of the comatose patients following TBI.
Although right median nerve electrical stimulation (RMNS) has been used clinically for more than two decades, no strong evidence of efficacy was generated because of the limitations in the past trials including a small sample size or the inappropriate study design. In the present study, a multicenter research network with inclusion of neurotrauma centers from China, India, Nepal and Kazakhstan was established with the aim to validate the efficacy and safety of a promising intervention strategy for traumatic coma at early stage. Since RMNS is a simple, inexpensive, noninvasive technique with a good safety profile, our study will probably add more evidence to the treatment of traumatic coma in Asian countries.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed history of closed traumatic brain injury 10 days before enrollment
- •A Glasgow coma scale (GCS) score of 4-8 or the motor part less than 5 if the patient received tracheotomy.
- •18-65 years of age
排除标准
- •Unstable vital signs
- •Have a history of severe cardiac arrhythmias, implanted pacemaker, as well as seizures
- •Pregnancy
- •No informed consent
结局指标
主要结局
Proportion of patients returning consciousness
时间窗: Within six months after injury
The term "consciousness" is defined when the patient shows objective ability to respond to verbal commands.
次要结局
- Adverse events(Within six months post injury)
- Coma Recovery Scale-Revised (CRS-R)(six months post injury)
- Full Outline of UnResponsiveness scale(FOUR)(28 days post injury)
- Duration of unconsciousness(Within six months after injury)
- Glasgow Coma Scale (GCS)(28 days post injury)
- Disability Rating Scale (DRS)(six months post injury)