5-SENSE Score Validation Study

Epilepsy Intractable Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06138808
• Other study ID #: Pro00113692
• Status: Enrolling by invitation
• Start date: January 9, 2024
• Est. completion date: November 2025

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Epilepsy Intractable

Intervention

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

Locations

Country	Name	City	State
Australia	Mater Health	Brisbane
Australia	Alfred Health	Melbourne
Australia	Monash University	Melbourne	Victoria
Austria	Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg	Salzburg
Canada	Dalhousie Universiry and Hospital	Dalhousie	Nova Scotia
Canada	Wester University	London	Ontario
Czechia	Departmet of Neurology, Masaryk University Brno	Brno
Denmark	Danish Epilepsy Centre, Aarhus Universitets Hospital	Aarhus
France	Grenoble Institute of Neurosciences, Centre Hospitalier Universitaire Grenoble Alpes	Grenoble
France	Epilepsy Department University Hospitals of Marseille	Marseille
Germany	Epilepsy Centre, University Hospital Freiburg	Freiburg
Japan	University School of Medicine Kyoto	Kyoto
Romania	"Carol Davila" University of Medicine and Pharmacy	Bucharest
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Switzerland	Department of Clinical Neurosciences chez CHUV; Centre Hospitalier Universitaire Vaudois	Lausanne
United States	Northwestern University	Chicago	Illinois
United States	Duke University Health System	Durham	North Carolina
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Presbyterian-Shadyside Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Christian Doppler University Hospital

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG	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.	At time of SEEG, up to approximately 1 month
Primary	Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG	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.	At time of SEEG, up to approximately 1 month
Primary	Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG	Measured for participants undergoing SEEG	At time of SEEG, up to approximately 1 month
Primary	Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG	Measured for participants undergoing SEEG	At time of SEEG, up to approximately 1 month
Secondary	Specificity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG	For participants undergoing SEEG, information from auxiliary diagnostic methods, performed routinely during presurgical evaluation, namely FDG-PET, electrical source imaging (ESI) and/or magnetic source imaging (MSI) and ictal HMPAO-SPECT will be analyzed. The investigators will assess whether addition of those variables to the 5-SENSE Score could enhance score performance with higher specificity for identifying a focal SOZ	At time of SEEG, up to approximately 1 month
Secondary	Sensitivity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG	For participants undergoing SEEG, information from auxiliary diagnostic methods, performed routinely during presurgical evaluation, namely FDG-PET, electrical source imaging (ESI) and/or magnetic source imaging (MSI) and ictal HMPAO-SPECT will be analyzed. The investigators will assess whether addition of those variables to the 5-SENSE Score could enhance score performance with higher sensitivity for identifying a focal SOZ	At time of SEEG, up to approximately 1 month
Secondary	Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not	Before SEEG, the decision whether to proceed with SEEG or not is made blinded from the 5- SENSE Score in a Multidisciplinary Team Discussion (MTD). Following the decision, the 5-SENSE Score will be calculated for each participant by the principal investigator. Concordance of the 5-SENSE Score with the decision made in the MTD will be assessed.	At enrollment