Periodic Reporting for period 1 - EpiGrid (EpiGrid: Soft and flexible high density electrode grids for epilepsy surgery)
Período documentado: 2023-03-01 hasta 2024-08-31
Epilepsy is a highly prevalent brain disorder affecting 1% of the population. Brain surgery can cure epilepsy if we can delineate the diseased tissue intra-operatively. Unfortunately this delineation is currently not performed precisely and leads to poor success rates (50-70%). High frequency oscillations (HFOs) have been identified as a biomarker of epileptogenic tissues, which can be electrically recorded with intraoperative electrocorticography. These HFOs are specific of diseased epileptogenic brain tissues and remnance after an initial resection predicts continuation of seizures after surgery and thus may indicate incomplete removal. The problem is that currently available electrode grids do not provide an adequate recording resolution (too low electrode density). Moreover these electrodes are made of stiff materials, which yields low signal-to-noise level when recording from the cortical surface and which does not offer the possibility to record from within resection cavities, as the rigid electrodes cannot conform to the curvature of the cavity. We need high density flexible electrode grids that can adhere to the cortical surface and cavities. Neurosoft Bioelectronics produces flexible and high density electrode grids based on unique stretchable soft electrodes. Our goal is to use this grant to translate our clinical needs into an optimal design of soft electrode grids adapted for epilepsy surgery, with the help of an industrial designer. We will first test these newly designed soft electrodes in vitro for clinical handability and improved signal quality, and eventually test them during epilepsy surgery in 12 patients. The recorded signals and clinical outcomes will be compared to those from standard rigid electrode grids. Improved delineation of the epileptogenic tissue will lead to a higher succes rate, make epilepsy surgery a first choice treatment, and over all change this otherwise life-long disease into a curable disorder for many people.
We designed and tested the envisioned product: the EpiGrid with several design iterations outsite of the actual surgeries. Prototypes were produced by Neurosoft, testing wass done by Productzaken with users (neurosurgeons, clinical neurophysiologists, technical clinicians, EEG technicians) from the University Medical Center Utrecht. Eventually, we came up with one optimal design to be tested in a clinical trial. We tested the device for recording properties in vitro test settings, we tested cables and other accesories. We tested sterilization procedures.
A protocol was writen and approval by the ethical committee of the University Medical Center Utrecht. This protocol includes a design iteration in the middle of the pilot period. It includes the development of a new way to test signal-to-noise quality in these type of backgroup EEG data. This was presented at the European Epilepsy Congres 2024.
The actual clinical testing was intended to start within the 18 months of the project, but was delayed because of production issues. The expected start date is now December 2024. We are recruiting patients to participate.
A protocol was writen and approval by the ethical committee of the University Medical Center Utrecht. This protocol includes a design iteration in the middle of the pilot period. It includes the development of a new way to test signal-to-noise quality in these type of backgroup EEG data. This was presented at the European Epilepsy Congres 2024.
The actual clinical testing was intended to start within the 18 months of the project, but was delayed because of production issues. The expected start date is now December 2024. We are recruiting patients to participate.
The key need to ensure further success is the clinical research that will follow: first a pilot study using the currently designed and soon produced EpiGrids during epilepsy surgery and comparing the performance in signal-to-noise quality to standard clinically used electrode grids. Gladly, we extended the ERC starting grant and received additional national funding to finish those recordings. The next step would be to use the EpiGrids for future epilepsy surgeries, evaluate the signals for optimal recognition of the epileptic tissue, using the signals for clinical decision making. To this end, we envision to built a broadly functioning product including: 1) further design optimization of the EpiGrids; 2) improved data integration and interpretation using artificial intelligence and enabling clinical reading of this information by building a graphical user interface to visualize and clinically interpret the data; 3) designing a way to project the results directly to the neurosurgical field of view, e.g. by augmented reality.