5-SENSE Score Validation Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Epilepsy Intractable

Intervention / Treatment
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* Other: Stereoelectroencephalography (SEEG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stereoelectroencephalography (SEEG)<br>Participants undergoing SEEG as part of standard of care. | Other: Stereoelectroencephalography (SEEG)<br>* Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol.<br>|
| Control Group<br>Participants not undergoing SEEG as part of standard of care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, surgery, stereo-electroencephalography