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| Name | Class |
|---|---|
| All India Institute of Medical Sciences | OTHER |
| JSC National Center for Neurosurgery, Republic of Kazakhstan | UNKNOWN |
| College of Medical Sciences Teaching Hospital. Nepal | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RMNS group | Experimental | Focus intervention: right median nerve stimulation plus standard management |
|
| Control group | No Intervention | Standard management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Right median nerve stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoyi Gao | Contact | guoyigao@gmail.com | ||
| Jin Lei | Contact | smiles1949@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiyao Jiang | RenJi Hospital | Study Chair |
| Junfeng Feng | RenJi Hospital | Study Director |
| Guoyi Gao | RenJi Hospital |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25664378 | Background | 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. | |
| 16350980 | Background | 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. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D003128 | Coma |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The potential adverse events include but not limited to seizures, intracranial bleeding, increased sympathetic activity and so on.
| Within six months post injury |
| Glasgow Coma Scale (GCS) | 28 days post injury |
| Coma Recovery Scale-Revised (CRS-R) | six months post injury |
| Disability Rating Scale (DRS) | six months post injury |
| Full Outline of UnResponsiveness scale(FOUR) | 28 days post injury |
| Principal Investigator |
| 14518515 | Background | 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. |
| 14518514 | Background | 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. |
| 11595086 | Background | 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. |
| 37178149 | Derived | 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. |
| 28693604 | Derived | 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. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |