Asia Coma Electrical Stimulation (the ACES Trial)

NCT02645578 | Unknown Phase 3 DMC

• 1 other identifier: Renjineuro
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

Coma; traumatic brain injury; median nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of unconsciousness

  Within six months after injury

• Adverse events

  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

Study Arms (2)

RMNS group

EXPERIMENTAL

Focus intervention: right median nerve stimulation plus standard management

Device: Right median nerve stimulation

Control group

NO INTERVENTION

Standard management

Interventions

Right median nerve stimulation DEVICE

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.

Also known as: RMNS

RMNS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age

You may not qualify if:

• Unstable vital signs
• Have a history of severe cardiac arrhythmias, implanted pacemaker, as well as seizures
• Pregnancy
• No informed consent

Sponsors & Collaborators

• RenJi Hospital: lead
• All India Institute of Medical Sciences: collaborator
• JSC National Center for Neurosurgery, Republic of Kazakhstan: collaborator
• College of Medical Sciences Teaching Hospital. Nepal: collaborator

Related Publications (7)

• 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.

  PMID: 25664378 BACKGROUND

• 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. doi: 10.1080/09602010443000317.

  PMID: 16350980 BACKGROUND

• 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. doi: 10.1007/978-3-7091-6081-7_3.

  PMID: 14518515 BACKGROUND

• Cooper EB, Cooper JB. Electrical treatment of coma via the median nerve. Acta Neurochir Suppl. 2003;87:7-10. doi: 10.1007/978-3-7091-6081-7_2.

  PMID: 14518514 BACKGROUND

• 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. doi: 10.1080/02699050110065709.

  PMID: 11595086 BACKGROUND

• Wu X, Xie L, Lei J, Yao J, Li J, Ruan L, Hong J, Zheng G, Cheng Y, Long L, Wang J, Huang C, Xie Q, Zhang X, He J, Yu X, Lv S, Sun Z, Liu D, Li X, Zhu J, Yang X, Wang D, Bao Y, Maas AIR, Menon D, Xue Y, Jiang J, Feng J, Gao G; ACES Participants. Acute traumatic coma awakening by right median nerve electrical stimulation: a randomised controlled trial. Intensive Care Med. 2023 Jun;49(6):633-644. doi: 10.1007/s00134-023-07072-1. Epub 2023 May 13.

  PMID: 37178149 DERIVED

• 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.

  PMID: 28693604 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Coma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiyao Jiang

  RenJi Hospital

  STUDY CHAIR

• Junfeng Feng

  RenJi Hospital

  STUDY DIRECTOR

• Guoyi Gao

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoyi Gao

CONTACT

guoyigao@gmail.com

Jin Lei

CONTACT

smiles1949@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 1, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 1, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share