No serious adverse events reported with Synchron brain-computer interface at 12 months
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Interim results from the COMMAND study evaluating the safety and efficacy of the Synchron brain-computer interface device found no serious adverse device-related events at 12 months, the company announced.
Tom Oxley, MD, PhD, CEO and founder of Synchron, told Healio in an email that the study “represents a pivotal step forward for the field of brain-computer interfaces.” The data were recently presented at the 2024 Congress of Neurological Surgeons in Houston.
All six participants with severe chronic bilateral upper limb paralysis met the primary endpoint of recording no device-related serious adverse events that resulted in death or permanent increased disability during the 1-year postimplant interval, Synchron reported in a company press release. This includes no serious brain or vascular-related adverse events during the study.
Supported by the NIH BRAIN initiative, COMMAND was conducted at three sites: Mount Sinai Health System in New York City, University at Buffalo Neurosurgery/Gates Vascular Institute and the University of Pittsburgh Medical Center, in collaboration with Carnegie Mellon University College of Engineering.
Synchron’s brain-computer interface (BCI) involves a minimally invasive procedure of blood vessel implantation on the surface of the motor cortex of the brain via the jugular vein. Once complete, the implant detects and wirelessly transmits motor signals from the brain that provide severely paralyzed people hands-free control over a range of personal devices.
Synchron additionally reported 100% accurate placement of the Stentrode device within 20 minutes.
“The ability to consistently capture motor intent and convert it into digital actions opens new possibilities for individuals with paralysis, offering a path to greater independence," Oxley said. "Our focus now is on refining this technology to ensure it is not only reliable but intuitive for users, with the potential to integrate seamlessly into everyday life.”