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The epilepsy bioinformatics study for anti-epileptogenic therapy (EpiBioS4Rx) clinical biomarker: Study design and protocol
- 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
Published Web Location
https://doi.org/10.1016/j.nbd.2018.07.025Abstract
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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