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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereoelectroencephalography (SEEG) | Participants undergoing SEEG as part of standard of care. |
| |
| Control Group | Participants not undergoing SEEG as part of standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereoelectroencephalography (SEEG) | Other | Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients will be prospectively recruited at 20-25 epilepsy centers from North America, Europe, Australia and Asia.
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| Name | Affiliation | Role |
|---|---|---|
| Birgit Frauscher, MD PD | Duke University | Principal Investigator |
| Alexandra Astner-Rohracher | Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39175939 | Derived | Astner-Rohracher A, Ho A, Archer J, Bartolomei F, Brazdil M, Cacic Hribljan M, Castellano J, Dolezalova I, Fabricius ME, Garces-Sanchez M, Hammam K, Ikeda A, Ikeda K, Kahane P, Kalamangalam G, Kalss G, Khweileh M, Kobayashi K, Kwan P, Laing JA, Leitinger M, Lhatoo S, Makhalova J, McGonigal A, Mindruta I, Mizera MM, Neal A, Oane I, Parikh P, Perucca P, Pizzo F, Rocamora R, Ryvlin P, San Antonio Arce V, Schuele S, Schulze-Bonhage A, Suller Marti A, Urban A, Villanueva V, Vilella Bertran L, Whatley B, Beniczky S, Trinka E, Zimmermann G, Frauscher B. Prognostic value of the 5-SENSE Score to predict focality of the seizure-onset zone as assessed by stereoelectroencephalography: a prospective international multicentre validation study. BMJ Neurol Open. 2024 Aug 21;6(2):e000765. doi: 10.1136/bmjno-2024-000765. eCollection 2024. |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| Presbyterian-Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | United States |
| Monash University | Melbourne | Victoria | 3800 | Australia |
| Mater Health | Brisbane | Australia |
| Alfred Health | Melbourne | Australia |
| Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg | Salzburg | 5020 | Austria |
| Dalhousie Universiry and Hospital | Dalhousie | Nova Scotia | Canada |
| Wester University | London | Ontario | Canada |
| Departmet of Neurology, Masaryk University Brno | Brno | Czechia |
| Danish Epilepsy Centre, Aarhus Universitets Hospital | Aarhus | 8200 | Denmark |
| Grenoble Institute of Neurosciences, Centre Hospitalier Universitaire Grenoble Alpes | Grenoble | France |
| Epilepsy Department University Hospitals of Marseille | Marseille | France |
| Epilepsy Centre, University Hospital Freiburg | Freiburg im Breisgau | Germany |
| University School of Medicine Kyoto | Kyoto | 606-8303 | Japan |
| "Carol Davila" University of Medicine and Pharmacy | Bucharest | Romania |
| Hospital Universitario y Politecnico La Fe | Valencia | Spain |
| Department of Clinical Neurosciences chez CHUV; Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |