NCT06138808Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 14 Nov 2023
- Start date
- Jan 2024
- Primary completion date
- Jan 2027
- Lead sponsor
- Duke University
- Diseases
- Epilepsy
- NCT number
- NCT06138808
What you commit to
- Study type: Observational
- Planned participants: 400
- From Jan 2024 to the primary completion date, Jan 2027
- 19 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- no telemetry/scalp EEG in center
- no protocol MRI in center
- subdural/GRID electrodes
Who the study is looking for
- 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)
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
| Mater Health Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Monash University Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Dalhousie Universiry and Hospital Coordinator of this site? Confirm its status | Dalhousie | Canada | Unknown status |
| Wester University Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Department of Clinical Neurosciences chez CHUV; Centre Hospitalier Universitaire Vaudois Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Departmet of Neurology, Masaryk University Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Epilepsy Centre, University Hospital Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Danish Epilepsy Centre, Aarhus Universitets Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Grenoble Institute of Neurosciences, Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Epilepsy Department University Hospitals of Marseille Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| University School of Medicine Kyoto Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| "Carol Davila" University of Medicine and Pharmacy Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Duke University Health System Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| University of Florida College of Medicine Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Presbyterian-Shadyside Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.