5-SENSE Score Validation Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• 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.
• 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

Trial sites (19)

More Duke University trials in Canada