Hybrid Micro-macro Electrodes in Patients With Epilepsy
Recruiting · NCT05335187 · Interventional (participants receive a specific treatment) · Lead sponsor: Pierre Mégevand
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The aim of the MicroEPI study is to know whether it is possible to use safely a medical device (a micro-electrode) that allows recording the activity of neurons in the human brain. Patients who suffer from drug-resistant epilepsy and who are candidates to epilepsy surgery to alleviate their condition sometimes require the implantation of intracranial EEG electrodes for a few weeks, in order to determine as best as possible which region of the brain to operate on. In the MicroEPI study, some of these electrodes will also comprise micro-electrodes, allowing us to record the activity of the patients' neurons during their epileptic seizures.
Who can take part
Inclusion criteria
- Patient 18 years old or older suffering from drug-resistant focal epilepsy.
- Candidate for epilepsy surgery.
- Requires evaluation with intracranial stereo-EEG electrodes.
- Able and willing to provide informed consent.
Exclusion criteria
- Any acute infection (e.g. fever, throat infection).
- Skin or scalp infection over the implantation site.
- Thin or fragile skull bones, which would prevent stereo-EEG electrodes from being anchored safely.
- Increased risk of infections, either from a medical condition or from immunosuppressant medication.
- Increased risk of bleeding, either from a medical condition or from antiplatelet or anticoagulant medication.
- Severe concomitant medical disease (including, but not limited to, cardiovascular, respiratory, renal or hepatic disease).
- Severe concomitant psychiatric disease or major psychological distress.
- Women who are pregnant or breastfeeding during the study.
- Patients who have an implanted stimulation device (e.g. pacemaker, defibrillator, neurostimulator).
Where it is running
2 locations listed.
- Hôpitaux Universitaires de Genève - Geneva, CH, Switzerland
- Inselspital Bern - Bern, Canton of Bern, Switzerland