Using micro-macro electrodes to study brain activity in epilepsy patients
Hybrid Micro-macro Electrodes to Record the Activity of Single Neurons During Seizures in Patients Who Suffer From Epilepsy
This study is testing a new device that records brain activity in people with hard-to-treat epilepsy to see how it works during seizures and help improve future treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Locations | 2 sites (Bern, Canton of Bern and 1 other locations) |
| Trial ID | NCT05335187 on ClinicalTrials.gov |
What this trial studies
The MicroEPI study aims to evaluate the safety and efficacy of a medical device called micro-macro electrodes for recording neuronal activity in patients with drug-resistant epilepsy. These patients, who are candidates for epilepsy surgery, will have the electrodes implanted alongside conventional intracranial EEG electrodes to monitor brain activity during seizures. The study seeks to enhance our understanding of neuronal behavior during epileptic episodes, which could inform future treatment strategies. The electrodes will be implanted for a duration of 2 to 4 weeks, allowing for comprehensive data collection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with drug-resistant focal epilepsy who are eligible for epilepsy surgery.
Not a fit: Patients with acute infections, severe medical conditions, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from drug-resistant epilepsy.
How similar studies have performed: While the use of microelectrodes in epilepsy research is a novel approach, similar studies have shown promise in understanding neuronal activity during seizures.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Bern, Canton of Bern and 1 other locations
- Inselspital Bern — Bern, Canton of Bern, Switzerland (Recruiting)
- Hôpitaux Universitaires de Genève — Geneva, Ch, Switzerland (Recruiting)
Study contacts
- Study coordinator: Pierre Mégevand, MD, PhD
- Email: pierre.megevand@unige.ch
- Phone: +41 22 379 53 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.