Synchron, an endovascular brain-computer interface (BCI) company, has started patient enrolment for the COMMAND trial of its Synchron Switch device at the Gates Vascular Institute, a Kaleida Health facility in Buffalo, New York.
The COMMAND trial is designed to be an early feasibility study (EFS) that will mainly evaluate the safety of the brain-computer interface device in addition to studying its quantified efficacy measures.
According to the US-based Synchron, the Synchron Switch device is implanted via the blood vessels for people with no or limited mobility to operate mobile devices and computers using their thoughts.
The COMMAND trial is being undertaken under the first investigational device exemption (IDE) awarded by the US Food and Drug Administration (FDA) to a company evaluating a permanently implanted brain-computer interface.
The new site at Gates Vascular Institute is the third authorised COMMAND trial location. The other two are the University of Pittsburgh Medical Center and Mount Sinai Health System in New York.
Synchron said that the study will evaluate how Synchron Switch affects routine activities like texting, emailing, telehealth services, and online shopping in a new set of qualified patients.
The FDA designated Synchron as a breakthrough device in August 2020 and granted the IDE in July 2021.
Synchron CEO and founder Tom Oxley said: “Today marks an important milestone in our mission to advance technology access for the millions of people who have lost the ability to use digital devices.
“We are excited to expand the COMMAND trial with enrolment at Gates Vascular Institute as we look to advance a scalable BCI solution to the Western New York region and beyond.”
According to Synchron, by using a minimally invasive endovascular technique, the Synchron Switch brain-computer interface is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein.
Upon implantation, it is intended to recognise and wirelessly communicate motor intent from the brain. This helps in restoring the capacity of individuals with severe paralysis for controlling personal devices with hands-free point-and-click, the BCI company said.
