# The Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx) Project 3: Biomarkers of Human Epileptogenesis After Traumatic Brain Injury

> **NIH NIH U54** · UNIVERSITY OF SOUTHERN CALIFORNIA · 2020 · $953,874

## Abstract

ABSTRACT / PROJECT SUMMARY – PROJECT 3 – BIOMARKERS OF HUMAN EPILEPTOGENESIS
AFTER TRAUMATIC BRAIN INJURY
The mechanisms underlying human acquired epileptogenesis remain poorly understood and a novel
multimodal approach to study the process from inception to manifest clinical epilepsy is needed. We have
selected Post-Traumatic Epilepsy (PTE) as a model to pursue this understanding because the timing of the
potential epileptogenic insult is known and the period of epileptogenesis can be determined. The EpiBioS4Rx
Scientific Premise is Epileptogenesis after TBI can be prevented with specific treatments; the
identification of relevant biomarkers and performance or rigorous preclinical trials will permit the
future design and performance of economically feasible full-scale clinical trials of antiepileptogenic
therapies. In Project 3, we plan to perform a multicenter, multidisciplinary observational study of early
epileptogenesis after moderate-severe TBI in 300 subjects with the specific injury phenotype of temporal
and/or frontal lobe hemorrhagic contusional injury that matches the experimental injury models in animal
Projects 1 and 2. We plan four specific aims that feature determining measuring the presence of early
electroencephalographic, MRI and blood biomarkers of epileptogenesis. In aim 4, we plan to create the ideal
clinical trial network and trial design informed by our animal Project 2 as well as shared data from large
biomarkers trials in both adults (TRACK, CENTER) and children (ADAPT) with TBI. In the Public Engagement
Core, we have recruited an outstanding multidisciplinary team of consumers, consumer advocates and key
opinion leaders in TBI, PTE, and Epilepsy Clinical Trials to work in this project. We plan a highly integrated and
adaptive study design across all 3 Projects and 3 Cores of EpiBioS4Rx to enable a rigorous experimental
design for robust and unbiased results. Integration is demonstrated by injury type, methodology, mechanistic
investigation, shared analysis and methods, shared public engagement core, and shared DSMB The ultimate
goal is to develop a personalized medicine approach for a future definitive clinical trial for an antiepileptogenic
drug for PTE.

## Key facts

- **NIH application ID:** 9849341
- **Project number:** 5U54NS100064-04
- **Recipient organization:** UNIVERSITY OF SOUTHERN CALIFORNIA
- **Principal Investigator:** Paul M Vespa
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $953,874
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9849341

## Citation

> US National Institutes of Health, RePORTER application 9849341, The Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx) Project 3: Biomarkers of Human Epileptogenesis After Traumatic Brain Injury (5U54NS100064-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9849341. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*