Trials / Enrolling By Invitation
Enrolling By InvitationNCT06138808
5-SENSE Score Validation Study
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
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Stereoelectroencephalography (SEEG) | Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol. |
Timeline
- Start date
- 2024-01-09
- Primary completion
- 2027-01-01
- Completion
- 2027-06-01
- First posted
- 2023-11-18
- Last updated
- 2026-02-13
Locations
19 sites across 12 countries: United States, Australia, Austria, Canada, Czechia, Denmark, France, Germany, Japan, Romania, Spain, Switzerland
Source: ClinicalTrials.gov record NCT06138808. Inclusion in this directory is not an endorsement.