Synchron’s Brain-Computer Interface Evaluated in COMMAND Early Feasibility Study

October 3, 2024—Synchron recently announced positive results from the COMMAND early feasibility study, which is evaluating the safety and efficacy of the Synchron brain computer interface (BCI, called the Stentrode) in six patients over a 12-month period.

The results were presented by the COMMAND study Coprincipal Investigator Elad Levy, MD, at the 2024 Congress of Neurological Surgeons held September 28 to October 2 in Houston, Texas.

Dr. Levy is SUNY Distinguished Professor and L. Nelson Hopkins Endowed Chair of Neurosurgery at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo (UB) and Codirector of the Gates Stroke Center and Cerebrovascular Surgery at Kaleida Health’s Buffalo General Medical Center/Gates Vascular Institute in Buffalo, New York. He is President of UB Neurosurgery.

According to Synchron, the COMMAND study was conducted at three clinical sites: UB Neurosurgery/Gates Vascular Institute; Mount Sinai Health System in New York, New York; and UPMC, the University of Pittsburgh Medical Center, in collaboration with Carnegie Mellon University College of Engineering in Pittsburgh, Pennsylvania.

The study was conducted with support from the National Institutes of Health’s NIH BRAIN Initiative. It is being conducted under an FDA-approved investigational device exemption.

The COMMAND study investigators enrolled six patients with severe chronic bilateral upper-limb paralysis unresponsive to therapy, all of whom received the BCI implant. In September 2023, Synchron announced completion of enrollment in the study.

In the press release, Synchron reported that all six patients successfully met the primary endpoint of no device-related serious adverse events resulting in death or permanent increased disability during the 1-year postimplantation evaluation period. The COMMAND study results showed that patients had no serious adverse events related to the brain or vasculature during the 12-month period.

The study also demonstrated that brain signals related to motor intent can be consistently captured and transformed into digital motor outputs (DMOs), allowing participants to successfully perform a range of digital tasks. In 100% of patients, the Stentrode device was accurately deployed, achieving target motor cortex coverage in the brain for all six patients. The median deployment time was 20 minutes.

The company stated that the results highlight the Synchron BCI’s safety profile, stable signal performance, and reliable surgical delivery. As an endovascular BCI, the fully internalized system offers long-term signal stability, providing a new path for patients to regain functional independence through digital interfaces.

“The COMMAND study results represent a major medical milestone, confirming the safety of the Stentrode BCI with no neurologic safety events reported during the 12-month study period,” commented Dr. Levy. “This minimally invasive approach has the potential to unlock BCI technology at scale for the millions of patients with paralysis and other mobility challenges.”

The abstract is available on the CNS website. The presentation will also be accessible on the Media page of Synchron’s website, www.synchron.com.

The Synchron BCI, which is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein through an endovascular procedure, is designed to detect and wirelessly transmit motor intent out of the brain. It is intended to restore the capability for severely paralyzed people to control personal devices with hands-free point-and-click.

Tom Oxley, MD, who is CEO and Founder of Synchron and an instructor in the Department of Neurosurgery for Mount Sinai Health System, stated in the press release, “The users were able to generate DMOs with the BCI. These are simple, thought-derived expressions of intent, converted into digital actions on computers. Making the DMOs easy to use, stable over time, and generalizable across technology platforms will unlock layers of independence and autonomy for patients.”

In September, the company announced that a patient in the United States who had received the Synchron BCI implant successfully used the Amazon Alexa virtual assistant technology, marking the first demonstration of the BCI with this system.