5-SENSE Score Validation Study

Duke University

Status: Invitation-only

Conditions: Epilepsy Intractable

Treatments: Other: Stereoelectroencephalography (SEEG)

Study type: Observational

Funder types: Other

Identifiers

NCT06138808

Pro00113692

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Stereoelectroencephalography (SEEG)

Description:

Participants undergoing SEEG as part of standard of care.

Treatment:

Other: Stereoelectroencephalography (SEEG)

Control Group

Description:

Participants not undergoing SEEG as part of standard of care.