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ENROLLING BY INVITATION
NCT06138808

5-SENSE Score Validation Study

Sponsor: Duke University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2024-01-09

Completion Date

2027-06

Last Updated

2026-02-13

Healthy Volunteers

No

Interventions

OTHER

Stereoelectroencephalography (SEEG)

Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol.

Locations (19)

University of Florida College of Medicine

Gainesville, Florida, United States

Northwestern University

Chicago, Illinois, United States

Duke University Health System

Durham, North Carolina, United States

Presbyterian-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Monash University

Melbourne, Victoria, Australia

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, Canada

Wester University

London, Ontario, Canada

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