Pharmacoresistant focal epilepsy G40
Conditions
Interventions
Group 1: 1) Assessment of the time spent for inhouse ESL during multimodal non-invasive presurgical epilepsy evaluation. 2) Comparison of ESL results to other diagnostic findings and, if applicable, t
Sponsors
Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Epilepsie-Zentrum Berlin-Brandenburg
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: Pharmacoresistant focal epilepsy; non-invasive evaluation for a first resective epilepsy surgery at the EZBB
Exclusion criteria
Exclusion criteria: Lack of written informed consent; skull defect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As a measure of the effort for ESL, the first primary endpoint is the working time for processing each single case as well as for installation and maintenance of the IT infrastructure per month. As a measure of the benefit of newly implemented ESL, the second primary endpoint is the concordance of selfmade ESL results (a) with externally processed, CE-certified ESL as external reference standard, and (b) with the resected brain area with respect to 12-month postsurgical seizure outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the concordance of ESL findings with results of other localising diagnostic methods (seizure semiology, MRI, etc.), a comparison of two non-commercial ESL software packages, the medical team's subjective estimation whether ESL brought a gain of knowledge for the individual case, and 12-month postsurgical outcome of the patients evaluated with ESL in comparison to matched control patients operated without ESL. | — |
Countries
Germany
Contacts
Public ContactBernd Vorderwülbecke
Charité - Universitätsmedizin Berlin, Klinik für Neurologie
Outcome results
None listed