The epilepsy bioinformatics study for anti-epileptogenic therapy (EpiBioS4Rx) clinical biomarker: Study design and protocol

• Published in: Neurobiology of disease Vol. 123; pp. 110 - 114
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2019; Elsevier
• Subjects: Biomarkers - blood; Brain - physiopathology; Brain Injuries, Traumatic - blood; Brain Injuries, Traumatic - complications; Brain Injuries, Traumatic - diagnosis; Brain Injuries, Traumatic - physiopathology; Computational Biology; Epilepsy, Post-Traumatic - blood; Epilepsy, Post-Traumatic - diagnosis; Epilepsy, Post-Traumatic - etiology; Epilepsy, Post-Traumatic - physiopathology; Humans; Longitudinal Studies; Observational Studies as Topic; Prospective Studies; CDE; HFF; HIF-1α; p-tau; LFF; INF-γ; CK-BB; TBI; NSE; UCLA; PROMIS; IL-1β; IL-8; IL-6; eCRFs; ADAPT; Hz; SAE; DTI; BioSEND; GRE; FPI; pHFOs; rHFOSs; PTE; DSMB; MRI; cEEG; rs-BOLD; SD; 2D; T; NF-H; FLAIR; MBP; T1; T2; SWI; NIH; S100B; DAI; GOS-E; GFAP; CT; 3D; EpiBioS4Rx; TNF-α; GCS; LONI IDA; REDCap; ICU; USC LONI
• ISSN: 0969-9961; 1095-953X; 1095-953X
• DOI: 10.1016/j.nbd.2018.07.025

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.