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

Alexandra Astner-Rohracher, Alyssa Ho, John Archer, Fabrice Bartolomei, Milan Brazdil, Melita Cacic Hribljan, James Castellano, Irena Dolezalova, Martin Ejler Fabricius, Mercedes Garcés-Sanchez, Kahina Hammam, Akio Ikeda, Kristin Ikeda, Philippe Kahane, Giridhar Kalamangalam, Gudrun Kalss, Mays Khweileh, Katsuya Kobayashi, Patrick Kwan, Joshua Andrew LaingMarkus Leitinger, Samden Lhatoo, Julia Makhalova, Aileen McGonigal, Iona Mindruta, Mary Margaret Mizera, Andrew Neal, Irina Oane, Prachi Parikh, Piero Perucca, Francesca Pizzo, Rodrigo Rocamora, Philippe Ryvlin, Victoria San Antonio Arce, Stephan Schuele, Andreas Schulze-Bonhage, Ana Suller Marti, Alexandra Urban, Vincente Villanueva, Laura Vilella Bertran, Benjamin Whatley, Sandor Beniczky, Eugen Trinka, Georg Zimmermann, Birgit Frauscher

Publikation: Beitrag in FachzeitschriftArtikelPeer-reviewed

Abstract

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.

OriginalspracheEnglisch
Seiten (von - bis)e000765
FachzeitschriftBMJ neurology open
Jahrgang6
Ausgabenummer2
DOIs
PublikationsstatusVeröffentlicht - 21 Aug. 2024

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