Asia Coma Electrical Stimulation (the ACES Trial) (ACES)
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|ClinicalTrials.gov Identifier: NCT02645578|
Recruitment Status : Unknown
Verified December 2015 by Guoyi Gao, RenJi Hospital.
Recruitment status was: Not yet recruiting
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|TBI (Traumatic Brain Injury)||Device: Right median nerve stimulation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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 Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: RMNS group
Focus intervention: right median nerve stimulation plus standard management
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.
Other Name: RMNS
No Intervention: Control group
- Proportion of patients returning consciousness [ Time Frame: Within six months after injury ]The term "consciousness" is defined when the patient shows objective ability to respond to verbal commands.
- Duration of unconsciousness [ Time Frame: Within six months after injury ]This outcome is defined as the time between trauma and objective recovery of the ability to respond to verbal commands
- Adverse events [ Time Frame: Within six months post injury ]The potential adverse events include but not limited to seizures, intracranial bleeding, increased sympathetic activity and so on.
- Glasgow Coma Scale (GCS) [ Time Frame: 28 days post injury ]
- Coma Recovery Scale-Revised (CRS-R) [ Time Frame: six months post injury ]
- Disability Rating Scale (DRS) [ Time Frame: six months post injury ]
- Full Outline of UnResponsiveness scale(FOUR) [ Time Frame: 28 days post injury ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645578
|Contact: Guoyi Gaoemail@example.com|
|Contact: Jin Leifirstname.lastname@example.org|
|Study Chair:||Jiyao Jiang||RenJi Hospital|
|Study Director:||Junfeng Feng||RenJi Hospital|
|Principal Investigator:||Guoyi Gao||RenJi Hospital|