5-SENSE Score Validation Study

NCT06138808 · tracked via the Priya Life Science Germany tracker

Sponsor

Duke University

Phase

Observational

Started

2024-01-09

Last updated

2026-06-05

Condition(s) studied

Epilepsy Intractable

Investigational drug(s) / intervention(s)

Stereoelectroencephalography (SEEG)

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

Sex

ALL

Min age

15 Years

Max age

—

Healthy volunteers

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 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)

Facility	City	Region
University of Florida College of Medicine	Gainesville	Florida
Northwestern University	Chicago	Illinois
Duke University Health System	Durham	North Carolina
Presbyterian-Shadyside Hospital	Pittsburgh	Pennsylvania
Monash University	Melbourne	Victoria
Mater Health	Brisbane	Australia
Alfred Health	Melbourne	Australia
Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg	Salzburg	Austria
Dalhousie Universiry and Hospital	Dalhousie	Nova Scotia
Wester University	London	Ontario
Departmet of Neurology, Masaryk University Brno	Brno	Czechia
Danish Epilepsy Centre, Aarhus Universitets Hospital	Aarhus	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	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06138808 on ClinicalTrials.gov ↗ ← All trials in Germany