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The Epilepsy Bioinformatics Study for Anti-epileptogenic Therapy (EpiBioS4Rx) Clinical Biomarker: Study Design and Protocol

Abstract

The Epilepsy Bioinformatics Study for Anti-epileptogenic Therapy (EpiBioS4Rx) is a longitudinal prospective observational study funded by the National Institute of Health (NIH) to discover and validate observational biomarkers of epileptogenesis after traumatic brain injury (TBI). A multidisciplinary approach has been incorporated to investigate acute electrical, neuroanatomical, and blood biomarkers after TBI that may predict the development of post-traumatic epilepsy (PTE). We plan to enroll 300 moderate-severe TBI patients with a frontal and/or temporal lobe hemorrhagic contusion. Acute evaluation with blood, imaging and electroencephalographic monitoring will be performed and then patients will be tracked for 2 years to determine the incidence of PTE. Validation of selected biomarkers that are discovered in planned animal models will be a principal feature of this work. Specific hypotheses regarding the discovery of biomarkers have been set forth in this study. An international cohort of 13 centers spanning 2 continents will be developed to facilitate this study, and for future interventional studies.

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References
1.
Immonen R, Kharatishvili I, Grohn O, Pitkanen A . MRI biomarkers for post-traumatic epileptogenesis. J Neurotrauma. 2013; 30(14):1305-9. PMC: 3713441. DOI: 10.1089/neu.2012.2815. View

2.
Englander J, Bushnik T, Duong T, Cifu D, Zafonte R, Wright J . Analyzing risk factors for late posttraumatic seizures: a prospective, multicenter investigation. Arch Phys Med Rehabil. 2003; 84(3):365-73. DOI: 10.1053/apmr.2003.50022. View

3.
Chen W, Li M, Wang G, Yang X, Liu L, Meng F . Risk of post-traumatic epilepsy after severe head injury in patients with at least one seizure. Neuropsychiatr Dis Treat. 2017; 13:2301-2306. PMC: 5587192. DOI: 10.2147/NDT.S141486. View

4.
Gershon R, Wagster M, Hendrie H, Fox N, Cook K, Nowinski C . NIH toolbox for assessment of neurological and behavioral function. Neurology. 2013; 80(11 Suppl 3):S2-6. PMC: 3662335. DOI: 10.1212/WNL.0b013e3182872e5f. View

5.
Bragin A, Li L, Almajano J, Alvarado-Rojas C, Reid A, Staba R . Pathologic electrographic changes after experimental traumatic brain injury. Epilepsia. 2016; 57(5):735-45. PMC: 5081251. DOI: 10.1111/epi.13359. View