5-SENSE Score Validation Study

• Conditions: Epilepsy Intractable

• Registration Number: NCT06138808
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Study Start: 2024-01-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG	At time of SEEG, up to approximately 1 month	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.
Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG	At time of SEEG, up to approximately 1 month	Measured for participants undergoing SEEG
Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG	At time of SEEG, up to approximately 1 month	Measured for participants undergoing SEEG
Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG	At time of SEEG, up to approximately 1 month	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.

Secondary Outcome Measures

Name	Time	Method
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	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
Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not	At enrollment	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.
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	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

Trial Locations

Locations (19)

University of Florida College of Medicine; 🇺🇸 Gainesville, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Duke University Health System; 🇺🇸 Durham, North Carolina, United States

Presbyterian-Shadyside Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Monash University; 🇦🇺 Melbourne, Victoria, Australia

Mater Health; 🇦🇺 Brisbane, Australia

Alfred Health; 🇦🇺 Melbourne, Australia

Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg; 🇦🇹 Salzburg, Austria

Dalhousie Universiry and Hospital; 🇨🇦 Dalhousie, Nova Scotia, Canada

Wester University; 🇨🇦 London, Ontario, Canada

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