Asia Coma Electrical Stimulation (the ACES Trial)

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 3

Conditions: TBI (Traumatic Brain Injury)

Treatments: Device: Right median nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02645578

Renjineuro

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups

RMNS group

Experimental group

Description:

Focus intervention: right median nerve stimulation plus standard management

Treatment:

Device: Right median nerve stimulation

Control group

No Intervention group

Description:

Standard management