Asia Coma Electrical Stimulation (the ACES Trial)

TBI (Traumatic Brain Injury) Clinical Trial

— ACES  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02645578
• Other study ID #: Renjineuro
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 23, 2015
• Last updated: December 31, 2015
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2015
• Source: RenJi Hospital
• Contact: Guoyi Gao
• Email: guoyigao[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• TBI (Traumatic Brain Injury)

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
RenJi Hospital	All India Institute of Medical Sciences, New Delhi, College of Medical Sciences, Bharatpur, Chitwan, Nepal, JSC National Center for Neurosurgery, Republic of Kazakhstan

References & Publications (5)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Duration of unconsciousness	This outcome is defined as the time between trauma and objective recovery of the ability to respond to verbal commands	Within six months after injury	No
Secondary	Adverse events	The potential adverse events include but not limited to seizures, intracranial bleeding, increased sympathetic activity and so on.	Within six months post injury	Yes
Secondary	Glasgow Coma Scale (GCS)		28 days post injury	No
Secondary	Coma Recovery Scale-Revised (CRS-R)		six months post injury	No
Secondary	Disability Rating Scale (DRS)		six months post injury	No
Secondary	Full Outline of UnResponsiveness scale(FOUR)		28 days post injury	No