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

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ClinicalTrials.gov Identifier: NCT02645578
Recruitment Status : Unknown
Verified December 2015 by Guoyi Gao, RenJi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Collaborators:
All India Institute of Medical Sciences, New Delhi
JSC National Center for Neurosurgery, Republic of Kazakhstan
College of Medical Sciences, Bharatpur, Chitwan, Nepal
Information provided by (Responsible Party):
Guoyi Gao, 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.

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Device: Right median nerve stimulation Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: RMNS

No Intervention: Control group
Standard management



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Glasgow Coma Scale (GCS) [ Time Frame: 28 days post injury ]
  4. Coma Recovery Scale-Revised (CRS-R) [ Time Frame: six months post injury ]
  5. Disability Rating Scale (DRS) [ Time Frame: six months post injury ]
  6. Full Outline of UnResponsiveness scale(FOUR) [ Time Frame: 28 days post injury ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645578


Contacts
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Contact: Guoyi Gao guoyigao@gmail.com
Contact: Jin Lei smiles1949@163.com

Sponsors and Collaborators
RenJi Hospital
All India Institute of Medical Sciences, New Delhi
JSC National Center for Neurosurgery, Republic of Kazakhstan
College of Medical Sciences, Bharatpur, Chitwan, Nepal
Investigators
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Study Chair: Jiyao Jiang RenJi Hospital
Study Director: Junfeng Feng RenJi Hospital
Principal Investigator: Guoyi Gao RenJi Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guoyi Gao, Associate professor, RenJi Hospital
ClinicalTrials.gov Identifier: NCT02645578     History of Changes
Other Study ID Numbers: Renjineuro
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Guoyi Gao, RenJi Hospital:
Coma
traumatic brain injury
median nerve stimulation

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries