Prognostic value of the 5-SENSE Score to predict focality of the seizure-onset zone as assessed by stereoelectroencephalography: a prospective international multicentre validation study.

Introduction: Epilepsy surgery is the only curative treatment for patients with drug-resistant focal epilepsy. Stereoelectroencephalography (SEEG) is the gold standard to delineate the seizure-onset zone (SOZ). However, up to 40% of patients are subsequently not operated as no focal non-eloquent SOZ can be identified. The 5-SENSE Score is a 5-point score to predict whether a focal SOZ is likely to be identified by SEEG. This study aims to validate the 5-SENSE Score, improve score performance by incorporating auxiliary diagnostic methods and evaluate its concordance with expert decisions.
Methods and Analysis: Non-interventional, observational, multicentre, prospective study including 200 patients with drug-resistant epilepsy aged ≥15 years undergoing SEEG for identification of a focal SOZ and 200 controls at 22 epilepsy surgery centres worldwide. The primary objective is to assess the diagnostic accuracy and generalisability of the 5-SENSE in predicting focality in SEEG in a prospective cohort. Secondary objectives are to optimise score performance by incorporating auxiliary diagnostic methods and to analyse concordance of the 5-SENSE Score with the expert decisions made in the multidisciplinary team discussion.
Ethics and Dissemination: Prospective multicentre validation of the 5-SENSE score may lead to its implementation into clinical practice to assist clinicians in the difficult decision of whether to proceed with implantation. This study will be conducted in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2014). We plan to publish the study results in a peer-reviewed full-length original article and present its findings at scientific conferences.
Trial Registration Number: NCT06138808.
Competing Interests: AA-R has no conflict of interest related to this work. Outside of the submitted work, she acted as a paid consultant for Epilog and received travel support and speaker's honoraria from Eisai. PP has received speaker honoraria or consultancy fees to his institution from Chiesi, Eisai, LivaNova, Novartis, Sun Pharma, Supernus and UCB Pharma, outside the submitted work. He is an Associate Editor for Epilepsia Open. Furthermore, he is supported by an Emerging Leadership Investigator Grant from the Australian National Health and Medical Research Council (APP2017651), The University of Melbourne, Monash University, the Austin Medical Research Foundation and the Norman Beischer Medical Research Foundation. VV has participated in advisory boards and symposium organised by Angellini, Bial, Biocodex, Eisai, Jazz Pharmaceuticals, Novartis, Paladin, Takeda, UCB, Xenon. AU has served as a consultant for Neuropace. JC serves on the scientific advisory board at NeuroOne Medical Technologies. SS received speaker honoraria and consultancy fees from Greenwich, Neurelis, SK Life Science, Bioserenity, Monteris and UCB outside the submitted work. ASM has received speaker honoraria and consultancy fees from Paladin and Jazz Pharmaceuticals, outside the submitted work. GZ gratefully acknowledges the support of the WISS 2025 project ‘IDA-Lab Salzburg’ (20204-WISS/225/197-2019 and 20102-F1901166-KZP). ET reports personal fees from EVER Pharma, Marinus, Argenix his institution has received grants from Biogen, UCB Pharma, Eisai, Red Bull, Merck, Bayer, the European Union, FWF Österreichischer Fond zur Wissenschaftsforderung, Bundesministerium für Wissenschaft und Forschung and Jubilaumsfond der Österreichischen Nationalbank outside the submitted work. BF has no conflict of interest in relation to this work. Outside of this work, she received honoraria for speaking engagements/advisory board meetings from UCB, UNEEG, Paladin labs, Eisai and Natus. Furthermore, she received a project grant from the Canadian Institutes of Health Research (PJT-175056) as well as Start-up Funding from Duke University. All other coauthors report no conflict of interest related to this work.
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