Synchron has reported that its miniature brain-computer interface implant, threaded up through the blood vessels to help read the activity of the motor cortex, showed no major side effects in a year-long human safety study.
The company’s COMMAND trial enrolled six participants who had lost the use of their arms to paralysis, with support from the NIH’s BRAIN Initiative. All six met the study’s primary endpoint, showing no device-linked serious adverse events related to the brain or vasculature.
The participants also demonstrated that the wireless Stentrode device could capture motor signals and translate them into inputs for performing a range of digital tasks, such as pointing a cursor and clicking.
“The users were able to generate Digital Motor Outputs with the BCI. These are simple, thought-derived expressions of intent, converted into digital actions on computers,” Synchron founder and CEO Tom Oxley said in a statement. “Making the DMOs easy to use, stable over time and generalizable across technology platforms, will unlock layers of independence and autonomy for patients.”
Similar to a stent for cardiovascular disease, Synchron said that procedures to deploy the catheter-based, electrode-laced implant through the jugular vein took a median of 20 minutes. The study’s results were presented this week at the annual meeting of the Congress of Neurological Surgeons being held in Houston, Texas.
“This minimally-invasive approach has the potential to unlock BCI technology at scale for the millions of patients with paralysis and other mobility challenges,” said co-principal investigator Elad Levy, the L. Nelson Hopkins Endowed Chair of Neurosurgery at the University at Buffalo. Other clinical sites included Mount Sinai Health System in New York City and UPMC, in collaboration with Carnegie Mellon University.
Earlier this year, Synchron—a former Fierce 15 and Fierce 50 winner—showed that its implant is capable of interfacing with a range of consumer electronics. That includes operating the Apple Vision Pro headset, as a replacement for its gesture-based controls, and interacting with Amazon’s Alexa assistant to help manage smart home devices.