5-SENSE Score Validation Study

Prognostic Value of the 5-SENSE Score to Predict Focality of the Seizure-onset Zone as Assessed by Stereo-electroencephalography - a Prospective Multicenter Validation Study

The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.

Study Overview

• Status: Enrolling by invitation
• Conditions: Epilepsy Intractable
• Intervention / Treatment: Other: Stereoelectroencephalography (SEEG)

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
    • Mater Health
  • Melbourne, Australia
    • Alfred Health
  • Victoria
    • Melbourne, Victoria, Australia, 3800
      • Monash University
• Austria
  • Salzburg, Austria, 5020
    • Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg
• Canada
  • Nova Scotia
    • Dalhousie, Nova Scotia, Canada
      • Dalhousie Universiry and Hospital
  • Ontario
    • London, Ontario, Canada
      • Wester University
• Czechia
  • Brno, Czechia
    • Departmet of Neurology, Masaryk University Brno
• Denmark
  • Aarhus, Denmark, 8200
    • Danish Epilepsy Centre, Aarhus Universitets Hospital
• France
  • Grenoble, France
    • Grenoble Institute of Neurosciences, Centre Hospitalier Universitaire Grenoble Alpes
  • Marseille, France
    • Epilepsy Department University Hospitals of Marseille
• Germany
  • Freiburg im Breisgau, Germany
    • Epilepsy Centre, University Hospital Freiburg
• Japan
  • Kyoto, Japan, 606-8303
    • University School of Medicine Kyoto
• Romania
  • Bucharest, Romania
    • "Carol Davila" University of Medicine and Pharmacy
• Spain
  • Valencia, Spain
    • Hospital Universitario y Politecnico La Fe
• Switzerland
  • Lausanne, Switzerland
    • Department of Clinical Neurosciences chez CHUV; Centre Hospitalier Universitaire Vaudois
• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Presbyterian-Shadyside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients will be prospectively recruited at 20-25 epilepsy centers from North America, Europe, Australia and Asia.

Description

Inclusion Criteria:

• patients aged 15 years or older in whom no direct surgical approach can be offered and who are discussed in the multidisciplinary team discussion
• availability of complete non-invasive presurgical work-up (including high-resolution MRI according to the in-center epilepsy protocol, video-telemetry with the recording of a minimum of one habitual clinic and EEG seizure, available as original files for review)

Exclusion Criteria:

• no telemetry/scalp EEG in center
• no protocol MRI in center
• subdural/GRID electrodes

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stereoelectroencephalography (SEEG); Participants undergoing SEEG as part of standard of care.	Other: Stereoelectroencephalography (SEEG); Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol.
Control Group; Participants not undergoing SEEG as part of standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG	Prospective validation of the predictive value of the 5-SENSE score to identify a focal seizure onset zone (SOZ) in an independent patient sample. Measured for participants undergoing SEEG.	At time of SEEG, up to approximately 1 month
Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG	Prospective validation of the predictive value of the 5-SENSE score to identify a focal seizure onset zone (SOZ) in an independent patient sample. Measured for participants undergoing SEEG.	At time of SEEG, up to approximately 1 month
Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG	Measured for participants undergoing SEEG	At time of SEEG, up to approximately 1 month
Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG	Measured for participants undergoing SEEG	At time of SEEG, up to approximately 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG	For participants undergoing SEEG, information from auxiliary diagnostic methods, performed routinely during presurgical evaluation, namely FDG-PET, electrical source imaging (ESI) and/or magnetic source imaging (MSI) and ictal HMPAO-SPECT will be analyzed. The investigators will assess whether addition of those variables to the 5-SENSE Score could enhance score performance with higher specificity for identifying a focal SOZ	At time of SEEG, up to approximately 1 month
Sensitivity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG	For participants undergoing SEEG, information from auxiliary diagnostic methods, performed routinely during presurgical evaluation, namely FDG-PET, electrical source imaging (ESI) and/or magnetic source imaging (MSI) and ictal HMPAO-SPECT will be analyzed. The investigators will assess whether addition of those variables to the 5-SENSE Score could enhance score performance with higher sensitivity for identifying a focal SOZ	At time of SEEG, up to approximately 1 month
Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not	Before SEEG, the decision whether to proceed with SEEG or not is made blinded from the 5- SENSE Score in a Multidisciplinary Team Discussion (MTD). Following the decision, the 5-SENSE Score will be calculated for each participant by the principal investigator. Concordance of the 5-SENSE Score with the decision made in the MTD will be assessed.	At enrollment

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Christian Doppler University Hospital
• Investigators: Principal Investigator: Birgit Frauscher, MD PD, Duke University; Principal Investigator: Alexandra Astner-Rohracher, Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg

Publications and helpful links

General Publications

• Astner-Rohracher A, Ho A, Archer J, Bartolomei F, Brazdil M, Cacic Hribljan M, Castellano J, Dolezalova I, Fabricius ME, Garces-Sanchez M, Hammam K, Ikeda A, Ikeda K, Kahane P, Kalamangalam G, Kalss G, Khweileh M, Kobayashi K, Kwan P, Laing JA, Leitinger M, Lhatoo S, Makhalova J, McGonigal A, Mindruta I, Mizera MM, Neal A, Oane I, Parikh P, Perucca P, Pizzo F, Rocamora R, Ryvlin P, San Antonio Arce V, Schuele S, Schulze-Bonhage A, Suller Marti A, Urban A, Villanueva V, Vilella Bertran L, Whatley B, Beniczky S, Trinka E, Zimmermann G, Frauscher B. 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. BMJ Neurol Open. 2024 Aug 21;6(2):e000765. doi: 10.1136/bmjno-2024-000765. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: epilepsy; surgery; stereo-electroencephalography
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy
• Other Study ID Numbers: Pro00113692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No