Epilepsy Intractable
Conditions
Keywords
epilepsy, surgery, stereo-electroencephalography
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.
Interventions
OTHERStereoelectroencephalography (SEEG)
Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol.
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Australia, Austria, Canada, Czechia, Denmark, France, Germany, Japan, Romania, Spain, Switzerland, United States
Contacts
PRINCIPAL_INVESTIGATORBirgit Frauscher, MD PD
Duke University
PRINCIPAL_INVESTIGATORAlexandra Astner-Rohracher
Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg
Outcome results
None listed