drugset / Trial / NCT03475693
A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents
RandomizedParallel-groupSingle-blindTreatment
Summary
The objective of this study is to evaluate the efficacy of magnesium in symptomatic reduction of mild traumatic brain injury in the adolescent population in the acute setting of injury.
Timeline
- Start
- 2017-09-01
- Primary completion
- 2019-11-30
- Completion
- 2019-12-30
Publications
- Background Miller JW, D'Ambrosio R. When basic research doesn't translate to the bedside--lessons from the magnesium brain trauma study. Epilepsy Curr. 2007 Sep-Oct;7(5):133-5. doi: 10.1111/j.1535-7511.2007.00201.x. No abstract available.
- Background Arango MF, Bainbridge D. Magnesium for acute traumatic brain injury. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD005400. doi: 10.1002/14651858.CD005400.pub3.
- Background Sen AP, Gulati A. Use of magnesium in traumatic brain injury. Neurotherapeutics. 2010 Jan;7(1):91-9. doi: 10.1016/j.nurt.2009.10.014.
- Background Heath DL, Vink R. Concentration of brain free magnesium following severe brain injury correlates with neurologic motor outcome. J Clin Neurosci. 1999 Nov;6(6):505-9. doi: 10.1016/s0967-5868(99)90011-5.
- Background Temkin NR, Anderson GD, Winn HR, Ellenbogen RG, Britz GW, Schuster J, Lucas T, Newell DW, Mansfield PN, Machamer JE, Barber J, Dikmen SS. Magnesium sulfate for neuroprotection after traumatic brain injury: a randomised controlled trial. Lancet Neurol. 2007 Jan;6(1):29-38. doi: 10.1016/S1474-4422(06)70630-5.
- Background Zhao L, Wang W, Zhong J, Li Y, Cheng Y, Su Z, Zheng W, Guan XD. The effects of magnesium sulfate therapy after severe diffuse axonal injury. Ther Clin Risk Manag. 2016 Sep 27;12:1481-1486. doi: 10.2147/TCRM.S109482. eCollection 2016.
- Background Heath DL, Vink R. Traumatic brain axonal injury produces sustained decline in intracellular free magnesium concentration. Brain Res. 1996 Oct 28;738(1):150-3. doi: 10.1016/0006-8993(96)00957-2.
- Background Giza CC, Hovda DA. The new neurometabolic cascade of concussion. Neurosurgery. 2014 Oct;75 Suppl 4(0 4):S24-33. doi: 10.1227/NEU.0000000000000505.
- Background McIntosh TK, Faden AI, Yamakami I, Vink R. Magnesium deficiency exacerbates and pretreatment improves outcome following traumatic brain injury in rats: 31P magnetic resonance spectroscopy and behavioral studies. J Neurotrauma. 1988;5(1):17-31. doi: 10.1089/neu.1988.5.17.
- Background Hoane MR. Assessment of cognitive function following magnesium therapy in the traumatically injured brain. Magnes Res. 2007 Dec;20(4):229-36.
- Background Busingye DS, Turner RJ, Vink R. Combined Magnesium/Polyethylene Glycol Facilitates the Neuroprotective Effects of Magnesium in Traumatic Brain Injury at a Reduced Magnesium Dose. CNS Neurosci Ther. 2016 Oct;22(10):854-9. doi: 10.1111/cns.12591. Epub 2016 Jul 15.
- Background Cernak I, Vink R, Zapple DN, Cruz MI, Ahmed F, Chang T, Fricke ST, Faden AI. The pathobiology of moderate diffuse traumatic brain injury as identified using a new experimental model of injury in rats. Neurobiol Dis. 2004 Oct;17(1):29-43. doi: 10.1016/j.nbd.2004.05.011.
- Background McKee JA, Brewer RP, Macy GE, Borel CO, Reynolds JD, Warner DS. Magnesium neuroprotection is limited in humans with acute brain injury. Neurocrit Care. 2005;2(3):342-51. doi: 10.1385/NCC:2:3:342.
- Background Vollmer BL, Kirkwood MW, Comstock RD, Currie D, Grubenhoff JA. Assessing the Clinical Utility of the Question, "Is Your Child/Are You Back to Normal?" in Pediatric Concussion Symptom Resolution. Clin Pediatr (Phila). 2018 Feb;57(2):146-151. doi: 10.1177/0009922817693300. Epub 2017 Feb 15.
- Background Randolph C, Millis S, Barr WB, McCrea M, Guskiewicz KM, Hammeke TA, Kelly JP. Concussion symptom inventory: an empirically derived scale for monitoring resolution of symptoms following sport-related concussion. Arch Clin Neuropsychol. 2009 May;24(3):219-29. doi: 10.1093/arclin/acp025. Epub 2009 Jun 23.
- Results Li W, Bai YA, Li YJ, Liu KG, Wang MD, Xu GZ, Shang HL, Li YF. Magnesium sulfate for acute traumatic brain injury. J Craniofac Surg. 2015 Mar;26(2):393-8. doi: 10.1097/SCS.0000000000001339.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Magnesium Oxide | Small molecule | 400 mg | Oral |
| Background | Acetaminophen | Small molecule | 500 mg | — |
| Background | Ondansetron | Other / unclassified | 4 mg | Oral |