Synchron Enrolling Patients in its COMMAND Trial

Synchron’s COMMAND trial is underway at Gates Vascular Institute, a Kaleida Health facility in Buffalo, N.Y., and teaching affiliate of the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo (UB).
 
The COMMAND trial is an early feasibility study (EFS) that will primarily assess safety while beginning to explore quantified efficacy measures of Synchron Switch, a brain-computer interface device implanted through the blood vessels that allows people with no or limited mobility to operate technology such as mobile devices and computers using their thoughts.

“[This] 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,” Synchron Founder/CEO Tom Oxley, M.D., Ph.D. “We are excited to expand the COMMAND trial with enrollment at Gates Vascular Institute as we look to advance a scalable BCI solution to the Western New York region and beyond.”
 
The COMMAND trial is being conducted under the first investigational device exemption (IDE) awarded by the U.S. Food and Drug Administration (FDA) to a company assessing a permanently implanted BCI. The new site at Gates Vascular Institute marks the third approved COMMAND trial location, joining Mount Sinai Health System in New York City and the University of Pittsburgh Medical Center. The study will assess the impact of the Synchron Switch on daily tasks such as texting, emailing, online shopping and telehealth services in a new group of eligible patients.
 
The FDA granted Breakthrough Device designation to Synchron in August 2020 and an IDE in July 2021.
 
“It is humbling to be a part of breakthrough brain computer interface technology that can reconnect people with their loved ones and the outside world. We are fortunate to be able to bring this remarkable technology to our patients in western New York,” said Elad Levy, M.D., principal investigator and L. Nelson Hopkins III M.D. Chair of Neurosurgery, chairman, Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, UB.

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, through a minimally-invasive endovascular procedure. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, restoring the capability for severely paralyzed patients to control personal devices with hands-free point-and-click. Synchron recently published long-term safety results from its SWITCH study in Australia in JAMA Neurology.
 
“We are delighted to participate in this clinical study evaluating a first of its kind endovascular technology that allows people who have lost the ability to use their extremities to start regaining functionality. We believe this is simply the first step in a whole new clinical field of neuroendovascular electrophysiology,” said Adnan H. Siddiqui, M.D., Ph.D., FACS, FAHA, CEO and chief medical officer. Jacobs Institute, professor and vice chairman, director Neuroendovascular Fellowship & Research, Department of Neurosurgery, director Canon Stroke and Vascular Research Center, SUNY UB.
 
COMMAND trial sites in New York City, Buffalo and Pittsburgh are recruiting patients. 

Synchron is a clinical-stage endovascular brain computer interface (BCI) company. Since 2012, the company has been developing a BCI platform that avoids the need for open brain surgery by using a minimally-invasive procedure. Synchron’s research has been published in multiple peer-reviewed journals including JAMA Neurology, Nature Biotechnology, Nature Biomedical Engineering, and JNIS. Synchron is based in Brooklyn, N.Y., with R&D facilities in Melbourne, Australia. 

Buffalo General Medical Center/Gates Vascular Institute is the largest Kaleida Health facility and a major teaching affiliate of the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo. As a 484-bed acute care medical center located on the Buffalo Niagara Medical Campus in downtown Buffalo, NY, Buffalo General Medical Center/Gates Vascular Institute provides a wide spectrum of clinical inpatient and outpatient services, along with specialized medical and surgical programs, comprehensive vascular care, revolutionary neurological procedures and cardiac services.
 
The Jacobs Institute is a non-profit medical device innovation center whose mission is to accelerate the development of next-generation technologies in vascular medicine through collisions of physicians, engineers, entrepreneurs, and industry. The JI fosters medical collaboration and innovation through partnerships with the University at Buffalo, Kaleida Health, and industry.


Read more: Building a Network: How Synchron Is Developing a New Device—and a New Market