5-SENSE Score Validation Study

NCT06138808 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Epilepsy Intractable

Interventions

OTHER

Stereoelectroencephalography (SEEG)

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

Sponsors & Collaborators

Principal Investigators

  • Birgit Frauscher, MD PD · Duke University

  • Alexandra Astner-Rohracher · Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2027-01-31
Completion
2027-06-30

Countries

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

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06138808 on ClinicalTrials.gov