Asia Coma Electrical Stimulation (the ACES Trial)
- Conditions
- TBI (Traumatic Brain Injury)
- Interventions
- Device: Right median nerve stimulation
- Registration Number
- NCT02645578
- Lead Sponsor
- RenJi Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 360
- 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
- Unstable vital signs
- Have a history of severe cardiac arrhythmias, implanted pacemaker, as well as seizures
- Pregnancy
- No informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RMNS group Right median nerve stimulation Focus intervention: right median nerve stimulation plus standard management
- Primary Outcome Measures
Name Time Method Proportion of patients returning consciousness Within six months after injury The term "consciousness" is defined when the patient shows objective ability to respond to verbal commands.
- Secondary Outcome Measures
Name Time Method Adverse events Within six months post injury The potential adverse events include but not limited to seizures, intracranial bleeding, increased sympathetic activity and so on.
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 This outcome is defined as the time between trauma and objective recovery of the ability to respond to verbal commands
Glasgow Coma Scale (GCS) 28 days post injury Disability Rating Scale (DRS) six months post injury