Synchron’s COMMAND Trial of Brain-Computer Interface Enrolls Patients at the Gates Vascular Institute

March 20, 2023—Synchron, an endovascular brain-computer interface (BCI) company developing technology to restore functionality in patients with severe paralysis, announced that the COMMAND trial is commencing enrollment at its third approved site, the Gates Vascular Institute, which is a Kaleida Health facility and a teaching affiliate of the Jacobs School of Medicine and Biomedical Sciences of the University at Buffalo in Buffalo, New York. Synchron is based in Brooklyn, New York, with research and development facilities in Melbourne, Australia.

According to the company, the COMMAND early feasibility study will primarily assess safety while beginning to explore quantified efficacy measures of the Synchron Switch, a BCI 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.

The Synchron Switch BCI is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein in an endovascular procedure. The device 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 actions.

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 investigational device exemption in July 2021.

Synchron advised that in addition to the Gates Vascular Institute, other approved trial locations include Mount Sinai Health System in New York, New York, which was announced in May 2022, and the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania, which the company announced in October 2022.

On March 21, the Jacobs Institute, a nonprofit medical device innovation center that partners with Synchron and Kaleida Health, will convene a roundtable discussion that is targeted at physicians and clinical staff who treat diseases that cause paralysis.

The discussion will feature Tom Oxley, MD, CEO and Founder of Synchron; Adnan Siddiqui, MD, CEO, & CMO of the Jacobs Institute; Don Boyd, President & CEO of Kaleida Health; and study Principal Investigator Elad Levy, MD, who is the L. Nelson Hopkins III MD Chair of Neurosurgery, Chairman, Department of Neurosurgery, Jacobs School of Medicine & Biomedical Sciences.

“It is humbling to be a part of breakthrough BCI technology that can reconnect people with their loved ones and the outside world,” commented Dr. Levy in the company’s press release. “We are fortunate to be able to bring this remarkable technology to our patients in western New York.”

Dr. Siddiqui added, “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.”

Also in the press release, Dr. Oxley stated, “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 enrollment at Gates Vascular Institute as we look to advance a scalable BCI solution to the Western New York region and beyond.”

In January 2023, the company announced the publication of long-term safety results from the SWITCH clinical study. The findings included data from four patients with severe paralysis implanted with Synchron’s first-generation Stentrode neuroprosthesis device in Australia. The study found that it is possible to use the device to transmit neural signals from inside a blood vessel in the brain over a long-term period without any serious adverse events related to the device. Peter Mitchell, MMed, et al published the findings in JAMA Neurology (2023;80:270-278).