COMMAND Trial Patient Enrollment Completed

Synchron has finished enrolling patients in the U.S.-based COMMAND trial.
 
The trial recruited six patients and is being conducted under the first investigational device exemption (IDE) awarded by the U.S. Food and Drug Administration to a company assessing a permanently implanted BCI. The early feasibility study assesses safety while evaluating quantified efficacy measures of the Synchron Switch motor neuroprosthesis in patients with severe paralysis.

“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,” Synchron Founder/CEO Tom Oxley, M.D., Ph.D., said. “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 U.S.”
 
The primary goal of the study is to assess whether the device can be safely implanted into the brain’s blood vessels using neurointerventional procedures. For patients who can no longer use their hands, the study is additionally designed to evaluate how the BCI may enable use of their thoughts to control digital devices for daily tasks such as 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.
 
“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, M.D., Endowed Professor and division chief of Cerebrovascular Medicine, director, UPMC Stroke Institute, professor of Neurology and Neurosurgery at the University of Pittsburgh.
 
The Synchron Switch brain computer interface is implanted in the blood vessel on the surface of the brain’s motor cortex via the jugular vein, through a minimally-invasive endovascular procedure. Once implanted, it is 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. Synchron published long-term safety results in JAMA Neurology from the SWITCH study that enrolled four patients in Australia.
 
Synchron, an endovascular brain computer interface company, develops implantable neural interface technology. The clinical-stage company is working on a neuroprosthesis to restore motor signaling to control digital devices for people with severe motor impairment. Future applications may include the first implantable endovascular neuromodulation therapy and the potential to diagnose and treat conditions of the nervous system, including Parkinson’s disease, epilepsy, depression, and hypertension. Synchron is headquartered in New York City with facilities in Melbourne, Australia.