As part of a recently announced clinical trial, brain signal recording with the Wyss Center for Bio and Neuroengineering’s novel brain-monitoring technology, its subscalp Epios sensing electrodes, is being carried out for the first time in patients at the University Hospital Bern, Inselspital in Bern, Switzerland.
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, according to a Wyss Center press release. The trial will assess the feasibility, safety and recording ability of the electrodes, and will also test the tools developed to insert the leads based on required locations and patient-specific anatomy.
George Kouvas, 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 release continues, the leads are inserted beneath the scalp using dedicated surgical tools. The electrodes record electroencephalographic (EEG) brain activity 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 characterise epileptic seizures, as well as to localise the area of the brain in which the seizure starts.
“People with epilepsy often do not remember having a seizure, which can undermine treatment optimisation,” said Maxime Baud, senior physician, Inselspital, and Wyss Center staff neurologist (Bern, Switzerland). “Monitoring brain activity can give an accurate seizure count, but the standard tool for monitoring brain waves—electroencephalography caps—cannot be used beyond two weeks in the hospital. Epios fills this unmet need for long-term brain monitoring in everyday life.”
Wyss Center CEO Mary Tolikas, added: “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 benefitting 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. According to the release, 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 (Bern) earlier this year, and is expected to continue until the end of September 2022.