Synchron Completes Enrollment for BCI Paralysis Trial

Synchron, an endovascular brain-computer interface (BCI) company, completed patient enrollment in its U.S. based COMMAND trial for its Switch motor neuroprosthesis to restore function in patients with severe paralysis.
 
COMMAND enrolled six patients, and according to Synchron, is being conducted under the first investigational device exemption (IDE) granted by the U.S. Food and Drug Administration (FDA) to a company to evaluate a permanently implanted BCI. The early feasibility study will assess if the Switch BCI can be safely implanted in blood vessels in the brain via neurointerventional surgery.
 
The Synchron Switch BCI is implanted in the blood vessel on the motor cortex’s surface via the jugular vein in a minimally invasive, endovascular surgery. Once implanted, it’s designed to detect and wirelessly transmit motor intent out of the brain, intended to restore the capability for severely paralyzed patients to control personal devices with hands-free point-and-click.
 
For patients who can no longer use their hands, the study is also designed to assess how the BCI could allow use of thoughts to control digital devices for daily tasks like texting, emailing, online shopping, and telehealth services.
 
The COMMAND study is being conducted at three clinical sites: Mount Sinai Health System in New York City, University at Buffalo Neurosurgery and UPMC, in collaboration with Carnegie Mellon University College of Engineering. The study is being conducted with support from the NIH BRAIN Initiative.
 
“We would like to thank everyone who partnered with us to complete this important clinical trial enrollment milestone, especially patients and caregivers as well as the physicians and research staff at our clinical sites in the United States,” said Tom Oxley, MD, Ph.D., CEO, and founder of Synchron told the press. “We look forward to announcing the results from our COMMAND study and will continue to advance development of Synchron Switch towards a pivotal clinical trial in the US.”
 
“Giving patients the option to receive a BCI device without the need for open brain surgery could open up a new frontier in BCI. We look forward to analyzing the results of the study and potentially bringing this technology to those in need in the future,” 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.