Early clinical study will assess safety and feasibility of the Epios(TM) subscalp recording leads in epilepsy patients
Geneva, Switzerland - Brain signal recording with the Wyss Center for Bio and Neuroengineering’s subscalp Epios(TM) sensing electrodes (leads) is being carried out for the first time in patients at the University Hospital Bern, Inselspital. The clinical trial is the first step towards the validation of Epios, a minimally invasive, long-term brain monitoring system intended for people with drug resistant epilepsy. The trial will assess the feasibility, safety and recording ability of the electrodes and will test the tools developed to insert the leads based on required locations and patient specific anatomy.
George Kouvas , MBA, Wyss Center Chief Technology Officer said: "We are very excited to have started our much-anticipated first human clinical trial with the Epios leads. This study is a major milestone in our vision to bring the Epios system to neurology clinics."
In this first-in-human study, the leads are inserted beneath the scalp using dedicated surgical tools. The electrodes record electroencephalographic brain activity (EEG) in epilepsy patients over the duration of their hospital stay. The results of the study will determine the clinical utility of subscalp brain monitoring to detect and characterize epileptic seizures as well as localize the area of the brain in which the seizure starts.
"People with epilepsy often do not remember having a seizure which can undermine treatment optimization. Monitoring brain activity can give an accurate seizure count, but the standard tool for monitoring brain waves - electroencephalography (EEG) caps - cannot be used beyond two weeks in the hospital. Epios fills this unmet need for long-term brain monitoring in everyday life," said Professor Maxime Baud , MD, PhD, Senior Physician, Inselspital and Wyss Center Staff Neurologist.
Wyss Center’s CEO Mary Tolikas , PhD, MBA, said: "This clinical trial is the culmination of a close collaboration between Wyss Center engineers and the clinicians at Inselspital. By joining forces, we have accelerated the Epios long-term brain monitoring concept toward benefiting the patient."
Further clinical trials are being planned to validate the full Epios system, comprising the leads connected to a subscalp implant that would ultimately transmit the neural signals wirelessly to cloud software. This would allow people with epilepsy to monitor their condition 24 hours a day outside the hospital setting.
The start of the clinical trial follows approvals from Swissmedic and Swissethics ÜBern) earlier this year and is expected to continue until the end of September 2022. Further information about the study is available here.