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

• ClinicalTrials.gov Identifier: NCT02645578
• Recruitment Status: Unknown
• First Posted: January 1, 2016
• Last Update Posted: January 1, 2016
• Sponsor: RenJi Hospital
• Collaborators: All India Institute of Medical Sciences, New Delhi; JSC National Center for Neurosurgery, Republic of Kazakhstan; College of Medical Sciences Teaching Hospital. Nepal
• Information provided by (Responsible Party): Guoyi Gao, RenJi Hospital

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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 Teaching Hospital. Nepal

Investigators

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

More Information

Publications:

Lei J, Wang L, Gao G, Cooper E, Jiang J. Right Median Nerve Electrical Stimulation for Acute Traumatic Coma Patients. J Neurotrauma. 2015 Oct 15;32(20):1584-9. doi: 10.1089/neu.2014.3768. Epub 2015 May 7.

Cooper EB, Scherder EJ, Cooper JB. Electrical treatment of reduced consciousness: experience with coma and Alzheimer's disease. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):389-405.

Liu JT, Wang CH, Chou IC, Sun SS, Koa CH, Cooper E. Regaining consciousness for prolonged comatose patients with right median nerve stimulation. Acta Neurochir Suppl. 2003;87:11-4.

Cooper EB, Cooper JB. Electrical treatment of coma via the median nerve. Acta Neurochir Suppl. 2003;87:7-10.

Peri CV, Shaffrey ME, Farace E, Cooper E, Alves WM, Cooper JB, Young JS, Jane JA. Pilot study of electrical stimulation on median nerve in comatose severe brain injured patients: 3-month outcome. Brain Inj. 2001 Oct;15(10):903-10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wu X, Zhang C, Feng J, Mao Q, Gao G, Jiang J. Right median nerve electrical stimulation for acute traumatic coma (the Asia Coma Electrical Stimulation trial): study protocol for a randomised controlled trial. Trials. 2017 Jul 10;18(1):311. doi: 10.1186/s13063-017-2045-x.

• Responsible Party: Guoyi Gao, Associate professor, RenJi Hospital
• ClinicalTrials.gov Identifier: NCT02645578
• Other Study ID Numbers: Renjineuro
• First Posted: January 1, 2016
• 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:

Brain Injuries; Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries