G40.2
Conditions
Interventions
Group 1: Ten patients with pharmacoresistant epilepsy, for whom subcutaneous electrical stimulation was indicated and an EASEE electrode III was implanted above the epileptic focus, will be examined u
Sponsors
Interreg Oberrhein 2021-2027 (Wissenschaftsoffensive der Europäische Union)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Adult patients (ages 18-75, M/F/diverse) Patients for whom treatment with at least two antiepileptic drugs (at appropriate doses) has failed Focal epilepsy Patients with an epileptic focus or a predominant epileptic focus that can be clearly identified as the implantation site for the electrode based on EEG and clinical presentation Implantation of an EASEE electrode III above the epileptic focus Patients capable of providing appropriate consent prior to study procedures Patients able to attend regular doctor appointments as required by the protocol
Exclusion criteria
Exclusion criteria: Female patients who are pregnant or planning to conceive in the next 2 years Patients with a previous brain surgery Patients with a clinically significant or unstable medical condition (including heart disease, alcohol and/or drug abuse) or a progressive or degenerative central nervous system disorder Patients diagnosed with active psychosis, severe depression, or suicidal thoughts in the past year Patients with intellectual or cognitive impairment that makes it impossible to follow project instructions Any other reasons that prevent the execution of an MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary goal of the project is to investigate changes in brain connectivity before and after stimulation using EASEE electrodes (https://precisis.de/de/press/easee-receives-ce-certification/) in patients with pharmacoresistant focal epilepsy. Analysis results from HD-EEG, EEG-fMRI, and NIRS will be compared between the measurement points. The data will be evaluated using established workflows and network analysis metrics (average clustering coefficient, average shortest path length, assortativity, betweenness centrality, eigenvector centrality, degree/cost, global and local efficiency). The parameters are expected to be reviewed after the data collection phase (March/April 2027). | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secondary objective, we will investigate differences in cerebral connectivity between patients who show improvement in seizure frequency or severity after stimulation (responders) and those who do not show any improvement (non-responders). | — |
Countries
Germany
Contacts
Public ContactAndreas Schulze-Bonhage
Uniklinik Freiburg
Outcome results
None listed