5-SENSE Score Validation Study

Enrolling by invitation

Conditions studied: Epilepsy Intractable

In brief

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.

Key facts

Study ID

NCT06138808

Run by

Duke University

People needed

400

Starts

2024-01-09

Expected to finish

2027-06-01

Last updated by the study team

2026-06-05

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• no telemetry/scalp EEG in center
• no protocol MRI in center
• subdural/GRID electrodes

Where it is running

• 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

Full record on ClinicalTrials.gov

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