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.

Biostatistics and Big Medical Data Paracelsus Medical Private University Salzburg Austria

Bladin Berkovic Comprehensive Epilepsy Program The University of Melbourne Medicine at Austin Health Heidelberg Victoria Australia

Clinical Medicine University of Copenhagen Faculty of Health and Medical Sciences Kobenhavn Denmark

Clinical Neurophysiology Aarhus University Hospital Aarhus Denmark

Clinical Neurophysiology Rigshospitalet Kobenhavn Denmark

Department of Neuroscience Central Clinical School Monash University Faculty of Medicine Nursing and Health Sciences Melbourne Victoria Australia

Epilepsy Centre University Hospital Freiburg Department of Neurology Freiburg im Breisgau Germany

Institute for Child and Adolescent with Epilepsy Centre Hospitalier Universitaire Vaudois Lausanne Switzerland

Monash University Clayton Victoria Australia

Neurology Aix Marseille Universite Marseille France

Neurology Alfred Hospital Melbourne Victoria Australia

Neurology Dalhousie University Faculty of Medicine Halifax Nova Scotia Canada

Neurology Duke University Durham North Carolina USA

Neurology Grenoble Alpes University Hospital Grenoble France

Neurology Hospital del Mar Barcelona Spain

Neurology Hospital Universitari i Politècnic La Fe Valencia Spain

Neurology Kyoto University Graduate School of Medicine Faculty of Medicine Kyoto Japan

Neurology Masaryk University Faculty of Medicine Brno Czech Republic

Neurology Medical University of Innsbruck Department of Neurology and Neurosurgery Innsbruck Austria

Neurology Montreal Neurological Institute Hospital Montreal Quebec Canada

Neurology Paracelsus Medical University Salzburg Salzburg Austria

Neurology University of Florida Gainesville Florida USA

Neurology University of Medicine and Pharmacy Carol Davila Bucharest Bucuresti Romania

Neurology University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA

Neurology University of Texas McGovern Medical School Houston Texas USA

Neurology Western University Schulich School of Medicine and Dentistry London Ontario Canada

Neurosciences Mater Hospital Brisbane Brisbane Queensland Australia

Northwestern University Feinberg School of Medicine Chicago Illinois USA

Service de Neurophysiologie Clinique INSERM U751 CHU Timone Marseille France

UQ Faculty of Medicine Herston Queensland Australia

See more in PubMed

Wiebe S, Blume WT, Girvin JP, et al. A randomized, controlled trial of surgery for temporal-lobe epilepsy. N Engl J Med. 2001;345:311–8. doi: 10.1056/NEJM200108023450501. PubMed DOI

Dwivedi R, Ramanujam B, Chandra PS, et al. Surgery for Drug-Resistant Epilepsy in Children. N Engl J Med. 2017;377:1639–47. doi: 10.1056/NEJMoa1615335. PubMed DOI

Engel J, McDermott MP, Wiebe S, et al. Early surgical therapy for drug-resistant temporal lobe epilepsy: A randomized trial. JAMA. 2012;307:922–30. doi: 10.1001/jama.2012.220. PubMed DOI PMC

Jobst BC, Cascino GD. Resective epilepsy surgery for drug-resistant focal epilepsy: A review. JAMA. 2015;313:285–93. doi: 10.1001/jama.2014.17426. PubMed DOI

Vakharia VN, Duncan JS, Witt J-A, et al. Getting the best outcomes from epilepsy surgery. Ann Neurol. 2018;83:676–90. doi: 10.1002/ana.25205. PubMed DOI PMC

Frauscher B, Mansilla D, Abdallah C, et al. Learn how to interpret and use intracranial EEG findings. Epileptic Disord. 2024;26:1–59. doi: 10.1002/epd2.20190. PubMed DOI

Gonzalez-Martinez J, Bulacio J, Alexopoulos A, et al. Stereoelectroencephalography in the “difficult to localize” refractory focal epilepsy: early experience from a North American epilepsy center. Epilepsia. 2013;54:323–30. doi: 10.1111/j.1528-1167.2012.03672.x. PubMed DOI

Hall JA, Khoo HM. Robotic-Assisted and Image-Guided MRI-Compatible Stereoelectroencephalography. Can J Neurol Sci. 2018;45:35–43. doi: 10.1017/cjn.2017.240. PubMed DOI

Cardinale F, Rizzi M, Vignati E, et al. Stereoelectroencephalography: retrospective analysis of 742 procedures in a single centre. Brain (Bacau) 2019;142:2688–704. doi: 10.1093/brain/awz196. PubMed DOI

Jehi L, Morita-Sherman M, Love TE, et al. Comparative Effectiveness of Stereotactic Electroencephalography Versus Subdural Grids in Epilepsy Surgery. Ann Neurol. 2021;90:927–39. doi: 10.1002/ana.26238. PubMed DOI PMC

Astner-Rohracher A, Zimmermann G, Avigdor T, et al. Development and Validation of the 5-SENSE Score to Predict Focality of the Seizure-Onset Zone as Assessed by Stereoelectroencephalography. JAMA Neurol. 2022;79:70–9. doi: 10.1001/jamaneurol.2021.4405. PubMed DOI PMC

Jehi L, Yardi R, Chagin K, et al. Development and validation of nomograms to provide individualised predictions of seizure outcomes after epilepsy surgery: A retrospective analysis. Lancet Neurol. 2015;14:283–90. doi: 10.1016/S1474-4422(14)70325-4. PubMed DOI

Hadady L, Sperling MR, Alcala-Zermeno JL, et al. Prediction tools and risk stratification in epilepsy surgery. Epilepsia. 2024;65:414–21. doi: 10.1111/epi.17851. PubMed DOI

Spanedda F, Cendes F, Gotman J. Relations between EEG seizure morphology, interhemispheric spread, and mesial temporal atrophy in bitemporal epilepsy. Epilepsia. 1997;38:1300–14. doi: 10.1111/j.1528-1157.1997.tb00068.x. PubMed DOI

Bartolomei F, Lagarde S, Wendling F, et al. Defining epileptogenic networks: Contribution of SEEG and signal analysis. Epilepsia. 2017;58:1131–47. doi: 10.1111/epi.13791. PubMed DOI

Jayakar P, Gaillard WD, Tripathi M, et al. Diagnostic test utilization in evaluation for resective epilepsy surgery in children. Epilepsia. 2014;55:507–18. doi: 10.1111/epi.12544. PubMed DOI

Isnard J, Taussig D, Bartolomei F, et al. French guidelines on stereoelectroencephalography (SEEG) Neurophysiol Clin. 2018;48:5–13. doi: 10.1016/j.neucli.2017.11.005. PubMed DOI

Jehi L, Friedman D, Carlson C, et al. The evolution of epilepsy surgery between 1991 and 2011 in nine major epilepsy centers across the United States, Germany, and Australia. Epilepsia. 2015;56:1526–33. doi: 10.1111/epi.13116. PubMed DOI PMC

Katz JS, Abel TJ. Stereoelectroencephalography Versus Subdural Electrodes for Localization of the Epileptogenic Zone: What Is the Evidence? Neurotherapeutics. 2019;16:59–66. doi: 10.1007/s13311-018-00703-2. PubMed DOI PMC

Abou-Al-Shaar H, Brock AA, Kundu B, et al. Increased nationwide use of stereoencephalography for intracranial epilepsy electroencephalography recordings. J Clin Neurosci. 2018;53:132–4. doi: 10.1016/j.jocn.2018.04.064. PubMed DOI PMC

See more in PubMed

ClinicalTrials.gov
NCT06138808