5-SENSE Score Validation Study

NCT06138808 | Enrolling By Invitation

• 1 other identifier: Pro00113692
• Study Type: observational
• Target: 400
• Locations: 11 countries
• Sites: 18

Brief Summary

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.

Conditions

Epilepsy Intractable

Keywords

epilepsy; surgery; stereo-electroencephalography

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Specificity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG

  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

  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

  At enrollment

Study Arms (2)

Stereoelectroencephalography (SEEG)

Participants undergoing SEEG as part of standard of care.

Other: Stereoelectroencephalography (SEEG)

Control Group

Participants not undergoing SEEG as part of standard of care.

Interventions

Stereoelectroencephalography (SEEG) OTHER

Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol.

Stereoelectroencephalography (SEEG)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (19)

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Presbyterian-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Monash University

Melbourne, Victoria, 3800, Australia

Location

Mater Health

Brisbane, Australia

Location

Alfred Health

Melbourne, Australia

Location

Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg

Salzburg, 5020, Austria

Location

Dalhousie Universiry and Hospital

Dalhousie, Nova Scotia, Canada

Location

Wester University

London, Ontario, Canada

Location

Departmet of Neurology, Masaryk University Brno

Brno, Czechia

Location

Danish Epilepsy Centre, Aarhus Universitets Hospital

Aarhus, 8200, Denmark

Location

Grenoble Institute of Neurosciences, Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, France

Location

Epilepsy Department University Hospitals of Marseille

Marseille, France

Location

Epilepsy Centre, University Hospital Freiburg

Freiburg im Breisgau, Germany

Location

University School of Medicine Kyoto

Kyoto, 606-8303, Japan

Location

"Carol Davila" University of Medicine and Pharmacy

Bucharest, Romania

Location

Hospital Universitario y Politecnico La Fe

Valencia, Spain

Location

Department of Clinical Neurosciences chez CHUV; Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39175939 DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: January 9, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); ES (1); JP (1); US (4); CH (1); RO (1); FR (2); DK (1); CA (2); CZ (1); DE (1)