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5-SENSE Score Validation Study
5-SENSE Score Validation Study

NCT06138808

Enrolling By InvitationN/A

Sponsor: Duke University

Conditions: Epilepsy Intractable

Interventions: Stereoelectroencephalography (SEEG)

Countries: United States, Australia, Austria, Canada, Czechia, Denmark, France, Germany

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 overview

Sex: ALL

Age: 15 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (19)
  • Gainesville, Florida, United States
  • Chicago, Illinois, United States
  • Durham, North Carolina, United States
  • Pittsburgh, Pennsylvania, United States
  • Melbourne, Victoria, Australia
  • Brisbane, Australia
  • Melbourne, Australia
  • Salzburg, Austria
  • Dalhousie, Nova Scotia, Canada
  • London, Ontario, Canada
  • Brno, Czechia
  • Aarhus, Denmark
  • Grenoble, France
  • Marseille, France
  • Freiburg im Breisgau, Germany
  • Kyoto, Japan
  • Bucharest, Romania
  • Valencia, Spain
  • Lausanne, Switzerland