학술논문
The epilepsy bioinformatics study for anti-epileptogenic therapy (EpiBioS4Rx) clinical biomarker: Study design and protocol
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article
Author
Vespa, Paul M; Shrestha, Vikesh; Abend, Nicholas; Agoston, Denes; Au, Alicia; Bell, Michael J; Bleck, Thomas P; Blanco, Manuel Buitrago; Claassen, Jan; Diaz-Arrastia, Ramon; Duncan, Dominique; Ellingson, Ben; Foreman, Brandon; Gilmore, Emily J; Hirsch, Lawrence; Hunn, Martin; Kamnaksh, Alaa; McArthur, David; Morokoff, Andrew; O'Brien, Terrence; O'Phelan, Kristine; Robertson, Courtney L; Rosenthal, Eric; Staba, Richard; Toga, Arthur; Willyerd, Frederick A; Zimmermann, Lara; Yam, Elisa; Martinez, Susana; Real, Courtney; Engel, Jerome
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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.