micro-macro electrode implantation: One or a handful of micro-macro electrodes are implanted for 2-4 weeks in patients undergoing epilepsy monitoring with intracranial EEG electrodes.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Adverse events (safety outcome) — approximately 30 days Number of adverse and severe adverse events possibly, probably or definitely related to the study device
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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