Astner-Rohracher Alexandra, Ho Alyssa, Archer John, Bartolomei Fabrice, Brazdil Milan, Cacic Hribljan Melita, Castellano James, Dolezalova Irena, Fabricius Martin Ejler, Garcés-Sanchez Mercedes, Hammam Kahina, Ikeda Akio, Ikeda Kristin, Kahane Philippe, Kalamangalam Giridhar, Kalss Gudrun, Khweileh Mays, Kobayashi Katsuya, Kwan Patrick, Laing Joshua Andrew, Leitinger Markus, Lhatoo Samden, Makhalova Julia, McGonigal Aileen, Mindruta Iona, Mizera Mary Margaret, Neal Andrew, Oane Irina, Parikh Prachi, Perucca Piero, Pizzo Francesca, Rocamora Rodrigo, Ryvlin Philippe, San Antonio Arce Victoria, Schuele Stephan, Schulze-Bonhage Andreas, Suller Marti Ana, Urban Alexandra, Villanueva Vincente, Vilella Bertran Laura, Whatley Benjamin, Beniczky Sandor, Trinka Eugen, Zimmermann Georg, Frauscher Birgit
Neurology, Medical University of Innsbruck Department of Neurology and Neurosurgery, Innsbruck, Austria.
Neurology, Duke University, Durham, North Carolina, USA.
BMJ Neurol Open. 2024 Aug 21;6(2):e000765. doi: 10.1136/bmjno-2024-000765. eCollection 2024.
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.
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.
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.
NCT06138808.
癫痫手术是药物难治性局灶性癫痫患者的唯一治愈性治疗方法。立体定向脑电图（SEEG）是确定癫痫发作起始区（SOZ）的金标准。然而，高达40%的患者随后未接受手术，因为未发现局灶性非功能区SOZ。5-SENSE评分是一个五分制评分，用于预测SEEG是否可能识别出局灶性SOZ。本研究旨在验证5-SENSE评分，通过纳入辅助诊断方法提高评分性能，并评估其与专家决策的一致性。
一项非干预性、观察性、多中心、前瞻性研究，纳入200例年龄≥15岁的药物难治性癫痫患者，他们正在接受SEEG以确定局灶性SOZ，以及来自全球22个癫痫手术中心的200名对照。主要目的是在前瞻性队列中评估5-SENSE评分在预测SEEG局灶性方面的诊断准确性和普遍性。次要目的是通过纳入辅助诊断方法优化评分性能，并分析5-SENSE评分与多学科团队讨论中专家决策的一致性。
5-SENSE评分的前瞻性多中心验证可能会使其应用于临床实践，以协助临床医生做出是否进行植入的艰难决策。本研究将按照三理事会政策声明：涉及人类研究的伦理行为（2014年）进行。我们计划在同行评审的全文原创文章中发表研究结果，并在科学会议上展示研究结果。
NCT06138808。
