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Enrolling by Invitation

NCT Number: NCT06138808

5-SENSE Score 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.

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Key information

Conditions

Epilepsy Intractable Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Monash University, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereoelectroencephalography (SEEG)

Other

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

Primary outcomes

  1. Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG

    Time frame: 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.

  2. Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG

    Time frame: 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.

  3. Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG

    Time frame: At time of SEEG, up to approximately 1 month

    Measured for participants undergoing SEEG

  4. Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG

    Time frame: At time of SEEG, up to approximately 1 month

    Measured for participants undergoing SEEG

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 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

  3. Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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