Endovascular brain-computer interface (BCI) firm Synchron has announced the start of patient enrolment in the COMMAND study.
Patients will be enrolled at the Gates Vascular Institute, a Kaleida Health facility located in Buffalo, New York, US. The facility is also a teaching affiliate of the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo (UB).
The early feasibility study (EFS) will mainly evaluate the safety of the Synchron Switch, as well as start to assess quantified efficacy measures.
A BCI device, Synchron Switch is implanted using blood vessels. It aims to help people with no or limited mobility to operate technology, such as mobile devices and computers, using their thoughts.
Using a minimally-invasive endovascular procedure, it is implanted through the jugular vein and positioned in a blood vessel on the surface of the motor cortex of the brain.
The trial will evaluate the impact of the Synchron Switch on daily tasks, including texting, emailing, online shopping and telehealth services, in a new group of eligible patients.
According to the company, the study is being carried out under the first investigational device exemption (IDE) approval granted by the US Food and Drug Administration (FDA) for evaluating a permanently implanted BCI.
The company received breakthrough device designation from the FDA in August 2020, followed by the IDE in July 2021.
Synchron CEO and founder Dr 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.”