Neurobiology of Disease (Mar 2019)

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

  • Paul M. Vespa,
  • Vikesh Shrestha,
  • Nicholas Abend,
  • Denes Agoston,
  • Alicia Au,
  • Michael J. Bell,
  • Thomas P. Bleck,
  • Manuel Buitrago Blanco,
  • Jan Claassen,
  • Ramon Diaz-Arrastia,
  • Dominique Duncan,
  • Ben Ellingson,
  • Brandon Foreman,
  • Emily J. Gilmore,
  • Lawrence Hirsch,
  • Martin Hunn,
  • Alaa Kamnaksh,
  • David McArthur,
  • Andrew Morokoff,
  • Terrence O'Brien,
  • Kristine O'Phelan,
  • Courtney L. Robertson,
  • Eric Rosenthal,
  • Richard Staba,
  • Arthur Toga,
  • Frederick A. Willyerd,
  • Lara Zimmermann,
  • Elisa Yam,
  • Susana Martinez,
  • Courtney Real,
  • Jerome Engel, Jr

Journal volume & issue
Vol. 123
pp. 110 – 114

Abstract

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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.