Hybrid Micro-macro Electrodes in Patients With Epilepsy
Hybrid Micro-macro Electrodes to Record the Activity of Single Neurons During Seizures in Patients Who Suffer From Epilepsy
Pierre Mégevand
30 participants
Mar 30, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria9
- 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).
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Interventions
One or a handful of micro-macro electrodes are implanted for 2-4 weeks in patients undergoing epilepsy monitoring with intracranial EEG electrodes.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05335187