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NCT06138808

5-SENSE Score Validation Study

Enrolling by Invitation
Not specifiedAges 15+Observational
Duke University
~400 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Stereoelectroencephalography (SEEG)

At a glance

Recruiting sites
0 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG
Measured over At time of SEEG, up to approximately 1 month
+3 more outcomes measured

Conditions

Epilepsy Intractable

Explore related trials

Intractable Epilepsy

Where it's being run

19 sites across 17 states
Australia2
France2
Florida1
Illinois1
North Carolina1
Pennsylvania1
Victoria1
Austria1

Study leadership

  • Birgit Frauscher, MD PD · PRINCIPAL_INVESTIGATOR · Duke University
  • Alexandra Astner-Rohracher · PRINCIPAL_INVESTIGATOR · Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEGAt time of SEEG, up to approximately 1 month

    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.

  • Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEGAt time of SEEG, up to approximately 1 month

    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.

  • Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEGAt time of SEEG, up to approximately 1 month

    Measured for participants undergoing SEEG

  • Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEGAt time of SEEG, up to approximately 1 month

    Measured for participants undergoing SEEG