RecruitingNot Applicable

Hybrid Micro-macro Electrodes in Patients With Epilepsy

Switzerland30 participantsStarted 2023-03-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse events (safety outcome)

Timeframe: approximately 30 days

Trial details

NCT IDNCT05335187

SponsorPierre Mégevand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Pierre Mégevand, MD, PhD

+41 22 379 53 88 pierre.megevand@unige.ch

View on ClinicalTrials.gov More Epilepsy trials