5-SENSE Score Validation Study

NCT ID: NCT06138808

Last Updated: 2026-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-09

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy Intractable

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stereoelectroencephalography (SEEG)

Participants undergoing SEEG as part of standard of care.

Stereoelectroencephalography (SEEG)

Intervention Type OTHER

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

Control Group

Participants not undergoing SEEG as part of standard of care.

No interventions assigned to this group

Interventions

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Stereoelectroencephalography (SEEG)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Birgit Frauscher, MD PD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Alexandra Astner-Rohracher

Role: PRINCIPAL_INVESTIGATOR

Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg

Locations

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University of Florida College of Medicine

Gainesville, Florida, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Duke University Health System

Durham, North Carolina, United States

Site Status

Presbyterian-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Monash University

Melbourne, Victoria, Australia

Site Status

Mater Health

Brisbane, , Australia

Site Status

Alfred Health

Melbourne, , Australia

Site Status

Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg

Salzburg, , Austria

Site Status

Dalhousie Universiry and Hospital

Dalhousie, Nova Scotia, Canada

Site Status

Wester University

London, Ontario, Canada

Site Status

Departmet of Neurology, Masaryk University Brno

Brno, , Czechia

Site Status

Danish Epilepsy Centre, Aarhus Universitets Hospital

Aarhus, , Denmark

Site Status

Grenoble Institute of Neurosciences, Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, , France

Site Status

Epilepsy Department University Hospitals of Marseille

Marseille, , France

Site Status

Epilepsy Centre, University Hospital Freiburg

Freiburg im Breisgau, , Germany

Site Status

University School of Medicine Kyoto

Kyoto, , Japan

Site Status

"Carol Davila" University of Medicine and Pharmacy

Bucharest, , Romania

Site Status

Hospital Universitario y Politecnico La Fe

Valencia, , Spain

Site Status

Department of Clinical Neurosciences chez CHUV; Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Countries

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United States Australia Austria Canada Czechia Denmark France Germany Japan Romania Spain Switzerland

References

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Astner-Rohracher A, Ho A, Archer J, Bartolomei F, Brazdil M, Cacic Hribljan M, Castellano J, Dolezalova I, Fabricius ME, Garces-Sanchez M, Hammam K, Ikeda A, Ikeda K, Kahane P, Kalamangalam G, Kalss G, Khweileh M, Kobayashi K, Kwan P, Laing JA, Leitinger M, Lhatoo S, Makhalova J, McGonigal A, Mindruta I, Mizera MM, Neal A, Oane I, Parikh P, Perucca P, Pizzo F, Rocamora R, Ryvlin P, San Antonio Arce V, Schuele S, Schulze-Bonhage A, Suller Marti A, Urban A, Villanueva V, Vilella Bertran L, Whatley B, Beniczky S, Trinka E, Zimmermann G, Frauscher B. Prognostic value of the 5-SENSE Score to predict focality of the seizure-onset zone as assessed by stereoelectroencephalography: a prospective international multicentre validation study. BMJ Neurol Open. 2024 Aug 21;6(2):e000765. doi: 10.1136/bmjno-2024-000765. eCollection 2024.

Reference Type DERIVED
PMID: 39175939 (View on PubMed)

Other Identifiers

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Pro00113692

Identifier Type: -

Identifier Source: org_study_id

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