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TBI (Traumatic Brain Injury)Phase 3ACESNCT02645578

Asia Coma Electrical Stimulation (the ACES Trial)

A Phase 3 study testing Right median nerve stimulation in people with TBI (Traumatic Brain Injury), run by RenJi Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
TBI (Traumatic Brain Injury)
What is being tested?
Right median nerve stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
No sites listed yet
Study dates
Jan 2016to Dec 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Guoyi Gao contact

guoyigao@gmail.com

Jin Lei contact

smiles1949@163.com

About this study

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

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.

Read the 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.

Being tested
Right median nerve stimulation
Keywords
Coma, traumatic brain injury, median nerve stimulation
Medical subject headings
Brain Injuries, Traumatic, Coma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Right median nerve stimulationDevice

    Also called RMNS

    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.

Study groups in NCT02645578
Study groupRoleWhat they receive
RMNS groupExperimentalFocus intervention: right median nerve stimulation plus standard management
Receives: Device: Right median nerve stimulation
Control groupNo interventionStandard management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients returning consciousness

    The term "consciousness" is defined when the patient shows objective ability to respond to verbal commands.

    Measured: Within six months after injury

Secondary outcomes (6)

  1. Duration of unconsciousness

    This outcome is defined as the time between trauma and objective recovery of the ability to respond to verbal commands

    Measured: Within six months after injury

  2. Adverse events

    The potential adverse events include but not limited to seizures, intracranial bleeding, increased sympathetic activity and so on.

    Measured: Within six months post injury

  3. Glasgow Coma Scale (GCS)

    Measured: 28 days post injury

  4. Coma Recovery Scale-Revised (CRS-R)

    Measured: six months post injury

  5. Disability Rating Scale (DRS)

    Measured: six months post injury

  6. Full Outline of UnResponsiveness scale(FOUR)

    Measured: 28 days post injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02645578
Sponsor's protocol ID
Renjineuro
Acronym
ACES
Status last verified
Dec 2015
First submitted
23 Dec 2015
Last updated
1 Jan 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

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.

    PubMed 25664378

  • 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.

    PubMed 16350980

  • 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.

    PubMed 14518515

  • 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.

    PubMed 14518514

  • 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.

    PubMed 11595086

  • 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.

    PubMed 37178149

  • 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.

    PubMed 28693604

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Right median nerve stimulation in people with TBI (Traumatic Brain Injury), run by RenJi Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guoyi Gao (guoyigao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients returning consciousness (time frame: Within six months after injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02645578, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.

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