Synchron, an endovascular brain-computer interface (BCI) company developing technology to restore functionality in patients with severe paralysis, announces enrollment in the COMMAND trial has commenced at the University of Pittsburgh (the “University”), Pittsburgh.
The COMMAND trial is an early feasibility study (EFS) funded by the National Institutes of Health (NIH), and will primarily assess safety while beginning to explore quantified efficacy measures of Synchron’s Stentrode in patients with severe paralysis with the goal of enabling the patient to control digital devices, hands-free.
The COMMAND trial is being conducted under the first investigational device exemption (IDE) awarded by the FDA to a company assessing a permanently implanted BCI. This new site at the University marks the second approved COMMAND trial location, joining Mount Sinai in New York.
“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,” said Tom Oxley, MD, PhD, CEO & Founder, Synchron. “We are excited to expand the COMMAND trial with enrollment at the University as we look to advance a scalable BCI solution to market.”
The Stentrode is implanted within the motor cortex of the brain via the jugular vein in a minimally-invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent, restoring a capability for severely paralyzed patients to control personal devices with hands-free point-and-click. The trial will assess the impact of tasks such as texting, emailing, online shopping, and telehealth services. The FDA granted Breakthrough Device designation to Synchron in August 2020 and an IDE in July 2021.
“Synchron’s Stentrode has the potential to restore functionality to the millions of people worldwide suffering from paralysis,” said Raul Nogueira, MD, FAHA, FSIN, Endowed Professor & Division Chief of Cerebrovascular Medicine, Director, UPMC Stroke Institute, Professor of Neurology & Neurosurgery at the University of Pittsburgh. “Giving patients the option to receive this device without the need for open brain surgery, may open endless possibilities into the application and scalability of this promising technology.”
“This exciting technology may open up the possibility for patients with paralysis to use digital devices to communicate with loved ones again, and restore independence back into their lives,” said David Lacomis, MD, principal investigator and Chief of Neuromuscular Division at the University of Pittsburgh. “Something as simple as surfing the web or doing online grocery shopping can seem mundane to some, but it can change the world for someone who previously had those fundamental abilities taken away.”
COMMAND trial sites in New York City and Pittsburgh are recruiting patients. Referring physicians may direct their inquiries to [email protected] to be put in touch with a study coordinator. There is no guarantee of participation and principal investigators make the final determination of patient eligibility.
[Source(s): Synchron Inc, Business Wire]