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Asia Coma Electrical Stimulation (the ACES Trial)

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02645578
Acronym
ACES
Enrollment
360
Registered
2016-01-01
Start date
2016-01-31
Completion date
2017-12-31
Last updated
2016-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI (Traumatic Brain Injury)

Keywords

Coma, traumatic brain injury, median nerve stimulation

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.

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.

Interventions

DEVICERight 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.

Sponsors

All India Institute of Medical Sciences
CollaboratorOTHER
JSC National Center for Neurosurgery, Republic of Kazakhstan
CollaboratorUNKNOWN
College of Medical Sciences Teaching Hospital. Nepal
CollaboratorOTHER
RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients returning consciousnessWithin six months after injuryThe term consciousness is defined when the patient shows objective ability to respond to verbal commands.

Secondary

MeasureTime frameDescription
Adverse eventsWithin six months post injuryThe potential adverse events include but not limited to seizures, intracranial bleeding, increased sympathetic activity and so on.
Glasgow Coma Scale (GCS)28 days post injury
Duration of unconsciousnessWithin six months after injuryThis outcome is defined as the time between trauma and objective recovery of the ability to respond to verbal commands
Disability Rating Scale (DRS)six months post injury
Full Outline of UnResponsiveness scale(FOUR)28 days post injury
Coma Recovery Scale-Revised (CRS-R)six months post injury

Contacts

Primary ContactGuoyi Gao
guoyigao@gmail.com
Backup ContactJin Lei
smiles1949@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026