Status:
RECRUITING
Hybrid Micro-macro Electrodes in Patients with Epilepsy
Lead Sponsor:
Pierre Mégevand
Collaborating Sponsors:
Swiss National Science Foundation
Wyss Center for Bio and Neuroengineering
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Epilepsy is a common disease of the brain that can be severe or even cause death. What we call epilepsy is a tendency to suffer from epileptic seizures, which themselves consist in symptoms (e.g. loss...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05335187
Start Date
March 30 2023
End Date
September 1 2027
Last Update
September 23 2024
Active Locations (2)
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1
Inselspital Bern
Bern, Canton of Bern, Switzerland, 3010
2
Hôpitaux Universitaires de Genève
Geneva, CH, Switzerland, 1205