Common Data Elements for Meaningful and Generalized Integration of PTE Research

University Of Pennsylvania, Philadelphia PA

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Linked publications & trials

Abstract

Project Summary: Epilepsy impacts approximately 1% of the global population, affecting 50-70 million people worldwide. Post- traumatic epilepsy (PTE) is the leading cause of acquired epilepsy cases and accounts for over 5% of all epilepsy cases. Alarmingly, about 35% of epilepsy patients fail to respond to treatment, resulting in devastating consequences, such as increased mortality, psychiatric disorders, cognitive decline, and physical injuries. PTE disproportionately impacts young males, especially those transitioning into adulthood, often resulting in lifelong seizure burden. Patients with TBI present to medical care within hours, but PTE can develop months to years later, offering a critical window for intervention. Yet, no preventive treatments currently exist, and despite the potential of drugs approved for other conditions to prevent epileptogenesis, there is a shocking scarcity of clinical studies. Since 1990, only two Phase 3 studies have been conducted, and just two Phase 2 studies since 2000. Several factors hinder research progress: 1) Only a subset of TBI victims develop PTE, requiring large sample sizes that make trials both costly and logistically complex, and 2) The long duration of studies, typically 2 years, is dictated by the delayed onset of PTE, leading to prohibitively lengthy and expensive trials. In the past 15 years, three NIH- and DOD-funded prospective biomarker studies have focused on PTE (EpiBioS4Rx, TAPTE, and TRACK-TBI), but their differing study designs and endpoints limit our ability to cross- validate data across the studies. The lack of standardized, harmonized data across these studies makes it difficult to compare findings or combine data in bigger and more powered datasets. Although data collection standards have been developed within some of these multicenter studies to facilitate collaboration and data collection, at present there are no clinical PTE CDE sets that have been vetted, optimized and proposed for wider use among clinical PTE researchers that would enable data sharing and comparison across studies. This gap hinders progress in both TBI and epilepsy research. This effort will standardize PTE CDEs and ensure that these are readily available to the PTE research community through the Epilepsy.Science Portal and NLM.