Hybrid Micro-macro Electrodes in Patients With Epilepsy (MicroEPI)

Hybrid Micro-macro Electrodes to Record the Activity of Single Neurons During Seizures in Patients Who Suffer From Epilepsy

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: micro-macro electrode implantation

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 of consciousness, involuntary movements, abnormal sensations like hallucinations) caused by abnormally intense or synchronized activity of the brain's neurons. However, we still understand very poorly what exactly goes on at the level of neurons in the human brain during an epileptic seizure. This knowledge gap is due to the fact that the brain's neurons are very small structures and are very well protected by the skull, and are therefore hard to study in human beings. Gaining a better understanding of how neuronal activity goes awry during epileptic seizures could lead to better ways to treat this disease.

In the MicroEPI study, a medical device called micro-macro electrode (MME), manufactured by the company Dixi Medical (France), will be implanted in the brain of patients who must anyway receive intracranial EEG electrodes. These MME electrodes will replace one or a handful of conventional intracranial EEG electrodes. The implantation surgery will be performed in the operating room, under general anesthesia, by an experienced neurosurgeon. The electrodes will remain implanted for 2 to 4 weeks, with the exact duration depending on the time required for the clinical team caring for the patient to collect enough information on the patient's epilepsy. During the entire duration of the electrodes' implantation, the patient will remain hospitalized, and the electrical signals from their brain will be recorded continuously. At the end of this period, the electrodes will be explanted in the operating room. The safety of the MME electrodes, expressed in terms of the number of adverse events attributable to the MME, will be compared to current data on the safety of conventional intracranial EEG electrodes. The performance of the MME electrodes, in terms of the number of recorded neurons, will also be measured.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Mégevand, MD, PhD; Phone Number: +41 22 379 53 88; Email: pierre.megevand@unige.ch

Study Locations

• Switzerland
  • CH
    • Geneva, CH, Switzerland, 1205
      • Recruiting
      • Hôpitaux universitaires de Genève
      • Contact: Pierre Mégevand, MD, PhD; Phone Number: +41 79 553 51 33; Email: pierre.megevand@hcuge.ch
  • Canton of Bern
    • Bern, Canton of Bern, Switzerland, 3010
      • Recruiting
      • Inselspital Bern
      • Contact: Maxime Baud, MD, PhD; Phone Number: +41 31 664 12 22; Email: maxime.baud@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: micro-macro electrode; In this single-arm, open-label study, all patients receive one or a handful of micro-macro electrode (MME) in place of conventional intracranial EEG electrodes.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (safety outcome)	Number of adverse and severe adverse events possibly, probably or definitely related to the study device	approximately 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device malfunctions (performance outcome 1)	Number of device malfunctions preventing the acquisition of microscopic electrophysiological signals	approximately 30 days
Number of neurons recorded (performance outcome 2)	Number of individual neurons recorded per micro-electrode	approximately 30 days

Collaborators and Investigators

• Sponsor: Pierre Mégevand
• Collaborators: Swiss National Science Foundation; Wyss Center for Bio and Neuroengineering
• Investigators: Principal Investigator: Pierre Mégevand, MD, PhD, University of Geneva

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: epilepsy surgery; drug-resistant epilepsy; epilepsy monitoring unit; intracranial EEG; microelectrodes; neuronal recordings
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy
• Other Study ID Numbers: 2022-D0033; 194507 (Other Grant/Funding Number: Swiss National Science Foundation); 10001031 (Other Identifier: Swissmedic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The neurophysiological data will be made available to the research community on an open scientific repository at the study's end.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No