Asia Coma Electrical Stimulation (the ACES Trial)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Device: Right median nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unstable vital signs Have a history of severe cardiac arrhythmias, implanted pacemaker, as well as seizures Pregnancy No informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RMNS group<br>Focus intervention: right median nerve stimulation plus standard management | Device: Right median nerve stimulation<br>* Right median nerve electrical stimulation (RMNS) is administered via a pair of lubricated one-inch square rubber surface electrodes pasted on the volar aspect of the right distal forearm over the median nerve. An electrical neuromuscular stimulator supplied trains of asymmetric biphasic pluses at an amplitude of 20 milliamps with a pulse width of 300 microseconds at 40 Hz for 20 sec/min. The RMNS treatment continues 8 hours per day for two weeks.<br>* Other names: RMNS;|
| No Intervention: Control group<br>Standard management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients returning consciousness | The term consciousness is defined when the patient shows objective ability to respond to verbal commands. | Within six months after injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of unconsciousness | This outcome is defined as the time between trauma and objective recovery of the ability to respond to verbal commands | Within six months after injury | 
| Adverse events | The potential adverse events include but not limited to seizures, intracranial bleeding, increased sympathetic activity and so on. | Within six months post injury | 
| Glasgow Coma Scale (GCS) |  | 28 days post injury | 
| Coma Recovery Scale-Revised (CRS-R) |  | six months post injury | 
| Disability Rating Scale (DRS) |  | six months post injury | 
| Full Outline of UnResponsiveness scale(FOUR) |  | 28 days post injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coma, traumatic brain injury, median nerve stimulation