Enhancing Sudden Unexpected Death in Epilepsy (SUDEP) research through development of pre-clinical common data elements

CURE Epilepsy research staff have published two papers on pre-clinical data standardization in SUDEP! Thank you to the SUDEP Data Standardization Project Steering Committee and Working Group as well as the BAND Foundation.

SUDEP is a fatal complication for individuals living with epilepsy. While certain neurotransmitters and neuronal pathways have been associated with SUDEP, the exact biological mechanisms are unknown. Preclinical research has been instrumental in providing clues to the underlying pathology but is limited by a lack of standardized methodologies for describing and collecting data. A key outcome of the Basic Science working group of the 2020 SUDEP Coalition Summit was the recognition that the development of standardized tools would greatly enhance SUDEP research. Such a research infrastructure would increase experimental rigor, repeatability, reproducibility, and transparency and finally, increase the chances that preclinical SUDEP research can be translated into real benefits for people.

Building on standardized methodology, CURE Epilepsy researchers assembled a Steering Committee and Working Groups consisting of experts in preclinical and clinical SUDEP research to develop Common Data Elements (CDEs) and Case Report Forms (CRFs) to enable standardization and translation of preclinical SUDEP data.

The most important CRF for SUDEP preclinical studies is the Core and Death-Related Information CRF. This CRF gives researchers CDEs to note details of animal models used, experiment-related information, and details about triggered and spontaneous seizures. The seizure-related death information consists of CDEs related to observations at the time of death, characteristics of fatal seizures, the posture of the animal at the time of death, diet, medications, and any adverse health conditions. Recording these pieces of information is vital so researchers everywhere can be consistent in how they collect and study SUDEP data.

Systematic use of CDEs and CRFs in SUDEP preclinical research has the potential to increase the rigor and transparency of research. Core CDEs along with supplemental CDEs described in a companion paper can aid researchers working together toward a common goal of preventing SUDEP.

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