Clinical trial NCT06138808: 5-SENSE Score Validation Study
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Epilepsy Intractable
Keywords: epilepsy
surgery
stereo-electroencephalography
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Christian Doppler University Hospital
First posted: 2023-11-18
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will be prospectively recruited at 20-25 epilepsy centers from North America, Europe, Australia and Asia.

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.


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

Primary outcomes:
measure: Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG
timeFrame: At time of SEEG, up to approximately 1 month
measure: Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG
timeFrame: At time of SEEG, up to approximately 1 month
measure: Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
timeFrame: At time of SEEG, up to approximately 1 month
measure: Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
timeFrame: At time of SEEG, up to approximately 1 month
Secondary outcomes:
measure: Specificity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG
timeFrame: At time of SEEG, up to approximately 1 month
measure: Sensitivity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG
timeFrame: At time of SEEG, up to approximately 1 month
measure: Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not
timeFrame: At enrollment
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Pittsburgh
country: United States
facility: Presbyterian-Shadyside Hospital
state: Pennsylvania
city: Melbourne
country: Australia
facility: Monash University
state: Victoria
city: Brisbane
country: Australia
facility: Mater Health
city: Melbourne
country: Australia
facility: Alfred Health
city: Salzburg
country: Austria
facility: Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg
city: Dalhousie
country: Canada
facility: Dalhousie Universiry and Hospital
state: Nova Scotia
city: London
country: Canada
facility: Wester University
state: Ontario
city: Brno
country: Czechia
facility: Departmet of Neurology, Masaryk University Brno
city: Aarhus
country: Denmark
facility: Danish Epilepsy Centre, Aarhus Universitets Hospital
city: Grenoble
country: France
facility: Grenoble Institute of Neurosciences, Centre Hospitalier Universitaire Grenoble Alpes
city: Marseille
country: France
facility: Epilepsy Department University Hospitals of Marseille
city: Freiburg
country: Germany
facility: Epilepsy Centre, University Hospital Freiburg
city: Kyoto
country: Japan
facility: University School of Medicine Kyoto
city: Bucharest
country: Romania
facility: "Carol Davila" University of Medicine and Pharmacy
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Lausanne
country: Switzerland
facility: Department of Clinical Neurosciences chez CHUV; Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Duke University
name: Birgit Frauscher, MD PD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg
name: Alexandra Astner-Rohracher
role: PRINCIPAL_INVESTIGATOR
References: