Asia Coma Electrical Stimulation (the ACES Trial) (ACES)

December 31, 2015 updated by: Guoyi Gao, RenJi Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RMNS group
Focus intervention: right median nerve stimulation plus standard management
Device: Right median nerve stimulation
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.
Other Names:
  • RMNS
No Intervention: Control group
Standard management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients returning consciousness
Time Frame: Within six months after injury
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
Time Frame: 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
Within six months after injury
Adverse events
Time Frame: Within six months post injury
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)
Time Frame: 28 days post injury
28 days post injury
Coma Recovery Scale-Revised (CRS-R)
Time Frame: six months post injury
six months post injury
Disability Rating Scale (DRS)
Time Frame: six months post injury
six months post injury
Full Outline of UnResponsiveness scale(FOUR)
Time Frame: 28 days post injury
28 days post injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

All India Institute of Medical Sciences, New Delhi
College of Medical Sciences Teaching Hospital. Nepal
JSC National Center for Neurosurgery, Republic of Kazakhstan

Investigators

  • Study Chair: Jiyao Jiang, RenJi Hospital
  • Study Director: Junfeng Feng, RenJi Hospital
  • Principal Investigator: Guoyi Gao, RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 31, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Renjineuro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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