Enrolling by invitation NCT06138808
5-SENSE Score Validation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stereoelectroencephalography (SEEG).
- Who it may be relevant to
- Registry conditions: Epilepsy Intractable. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Austria, Canada, Czechia +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Other Stereoelectroencephalography (SEEG)
Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol.
Primary outcome measures
- 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]
- 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]
- 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]
- 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]
Secondary outcome measures (3)
- 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]
- 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]
- Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not [Time frame: At enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- University of Florida College of Medicine — Gainesville
- Northwestern University — Chicago
- Duke University Health System — Durham
- Presbyterian-Shadyside Hospital — Pittsburgh
Australia · 3 centers
- Monash University — Melbourne
- Mater Health — Brisbane
- Alfred Health — Melbourne
Canada · 2 centers
- Dalhousie Universiry and Hospital — Dalhousie
- Wester University — London
France · 2 centers
- Grenoble Institute of Neurosciences, Centre Hospitalier Universitaire Grenoble Alpes — Grenoble
- Epilepsy Department University Hospitals of Marseille — Marseille
Austria · 1 center
- Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre fo — Salzburg
Czechia · 1 center
- Departmet of Neurology, Masaryk University Brno — Brno
Denmark · 1 center
- Danish Epilepsy Centre, Aarhus Universitets Hospital — Aarhus
Germany · 1 center
- Epilepsy Centre, University Hospital Freiburg — Freiburg im Breisgau
Japan · 1 center
- University School of Medicine Kyoto — Kyoto
Romania · 1 center
- "Carol Davila" University of Medicine and Pharmacy — Bucharest
Spain · 1 center
- Hospital Universitario y Politecnico La Fe — Valencia
Switzerland · 1 center
- Department of Clinical Neurosciences chez CHUV; Centre Hospitalier Universitaire Vaudois — Lausanne
Publications
- 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 Arc PMID 39175939
Identifiers
NCT: NCT06138808 · Pro00113692