Evaluation of Flexible High-density SOFT ECoG Electrodes Compared to Standard Devices During Epilepsy Surgery

What this Trial Is About

Researchers are evaluating new flexible high-density SOFT ECoG electrode grids designed for use during epilepsy surgery. This study compares the performance and feasibility of these new electrodes, made by Neurosoft Bioelectronics SA, with the regular high-density electrode grids currently used at the study site. The investigation focuses on patients with focal epilepsy undergoing intraoperative monitoring during surgery. Participants will have at least two extra intracranial recordings taken with the SOFT ECoG flexible electrode grids before and after the surgical removal of brain tissue. These recordings are done alongside the standard recordings made with the currently approved device. The investigational device is used only for study recordings and does not influence clinical decisions, which are based on the standard CE-marked device. During the study, researchers will measure the background signal-to-noise ratio SNR from recordings up to 24 hours before surgery, as well as electrode performance, detection of epileptic biomarkers like spikes, and post-surgery recordings. They will also monitor surgical complications until hospital discharge, usually about 10 days after surgery, and evaluate device usability within 48 hours. Participants will be involved during the surgery and monitoring periods, with data collected through standard clinical procedures.

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