Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )

Launched by NEUROSOFT BIOELECTRONICS SA · Jan 3, 2024

Keywords

ClinConnect Summary

This clinical trial, called EpiGrid, is looking at a new type of flexible electrode grid that is used during epilepsy surgery. The goal is to see how well these new electrodes work compared to the regular ones that are typically used. Both types of electrodes help doctors monitor brain activity during surgery to pinpoint the areas causing seizures. Patients in the trial will have additional recordings with the new electrodes, alongside the standard ones, to compare their performance.

To participate in this study, patients need to be at least 18 years old and have a specific type of epilepsy that can be treated with surgery. They should also be willing to give their consent to take part in the study. Participants can expect to undergo some extra monitoring during their surgery, which will help doctors gather important information about how the new electrodes perform. It's important to note that certain conditions, like having had prior brain surgery or certain health issues, might prevent someone from joining the study. Overall, this trial aims to improve the tools available for epilepsy surgery, potentially leading to better outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years at the time of enrolment
• • Lesional epilepsy (incl. mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent stereoelectroencephalography (SEEG) preceding resective surgery)
• • Provided informed consent for study participation by the subject
• Exclusion Criteria:
• • Prior brain surgery (excl. SEEG)
• • Occipital lesion
• • Multiple epileptic foci or suspected dual pathology
• • Surgeries involving a disconnection, or hemispherectomy.
• • Planned awake surgery and/or functional recordings
• • Use of anticoagulants that cannot be discontinued during the perioperative period, or a factor XIII deficiency or any other haematological disease
• • Active participation in another investigational device study
• • Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study.
• • Insufficient understanding of Dutch language.