Hybrid Micro-macro Electrodes in Patients With Epilepsy

NCT05335187 | Recruiting DMC

• 3 other identifiers: 2022-D003319450710001031
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Epilepsy

Keywords

drug-resistant epilepsy; epilepsy monitoring unit; intracranial EEG; microelectrodes; neuronal recordings; epilepsy surgery

Outcome Measures

Primary Outcomes (1)

• Adverse events (safety outcome)

  Number of adverse and severe adverse events possibly, probably or definitely related to the study device

  approximately 30 days

Secondary Outcomes (2)

• Device malfunctions (performance outcome 1)

  approximately 30 days

• Number of neurons recorded (performance outcome 2)

  approximately 30 days

Study Arms (1)

micro-macro electrode

EXPERIMENTAL

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

Interventions

micro-macro electrode implantation DEVICE

One or a handful of micro-macro electrodes are implanted for 2-4 weeks in patients undergoing epilepsy monitoring with intracranial EEG electrodes.

micro-macro electrode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pierre Mégevand: lead
• Swiss National Science Foundation: collaborator
• Wyss Center for Bio and Neuroengineering: collaborator

Study Sites (2)

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève

Geneva, CH, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Pierre Mégevand, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 19, 2022
• Study Start: March 30, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CH (2)