Clinical trial NCT02645578: Asia Coma Electrical Stimulation (the ACES Trial)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: TBI (Traumatic Brain Injury)
Keywords: Coma
traumatic brain injury
median nerve stimulation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
name: JSC National Center for Neurosurgery, Republic of Kazakhstan
name: College of Medical Sciences Teaching Hospital. Nepal
First posted: 2016-01-01
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Proportion of patients returning consciousness
timeFrame: Within six months after injury
Secondary outcomes:
measure: Duration of unconsciousness
timeFrame: Within six months after injury
measure: Adverse events
timeFrame: Within six months post injury
measure: Glasgow Coma Scale (GCS)
timeFrame: 28 days post injury
measure: Coma Recovery Scale-Revised (CRS-R)
timeFrame: six months post injury
measure: Disability Rating Scale (DRS)
timeFrame: six months post injury
measure: Full Outline of UnResponsiveness scale(FOUR)
timeFrame: 28 days post injury
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Jiyao Jiang
role: STUDY_CHAIR
affiliation: RenJi Hospital
name: Junfeng Feng
role: STUDY_DIRECTOR
affiliation: RenJi Hospital
name: Guoyi Gao
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.