5-SENSE Score Validation Study

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Duke University
Study ID
NCT06138808
Status
Enrolling By Invitation

Conditions

  • Epilepsy Intractable

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 9, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Stereoelectroencephalography (SEEG)
    Participants undergoing SEEG as part of standard of care.
  • Arm: Control Group
    Participants not undergoing SEEG as part of standard of care.

Primary Outcome Measure

Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG [ Time Frame: At time of SEEG, up to approximately 1 month ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Florida College of MedicineGainesvilleFlorida32610-
Northwestern UniversityChicagoIllinois60611-
Duke University Health SystemDurhamNorth Carolina27710-
Presbyterian-Shadyside HospitalPittsburghPennsylvania15232-

Find similar trials in Gainesville, FL

By research site
University of Florida College of Medicine· Gainesville, FLNorthwestern University· Chicago, ILDuke University Health System· Durham, NCPresbyterian-Shadyside Hospital· Pittsburgh, PA

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