Synchron has cemented its position as the frontrunner in brain computer interface (BCI) clinical trials, after the company reported positive 12-month safety and efficacy data for its Stentrode device.
The results are from an early feasibility study (NCT05035823) investigating the technology in six patients with severe chronic bilateral upper-limb paralysis unresponsive to prior therapy.
Synchron reported that all six patients successfully met the primary endpoint of no device-related serious adverse events such as death or permanent increased disability during the evaluation period which lasted one year after implant. The feasibility study also demonstrated no serious adverse events (SAEs) related to the brain or vasculature during the 12-month period.
The study, named COMMAND, was conducted at three clinical sites in the US with support from the National Institutes of Health (NIH) BRAIN Initiative, a funding programme to advance treatments and initiatives for brain disorders. COMMAND is the first US Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trial of a permanently implanted BCI.
In terms of efficacy, Synchron said motor-related brain signals were consistently captured and transformed by Stentrode into digital motor outputs, allowing participants to successfully perform a range of digital tasks.
Brain-computer interfaces (BCIs), also called brain-machine interfaces, are chips implanted in the brain that take brain signals and translate them into commands. The signals are then relayed to a secondary, external device, which then carries out a specific function. At present, the main application is in the neuromuscular field, meaning paralysed patients can move muscles just by thoughts.
Stentrode is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein. Synchron said its device achieved target motor cortex coverage in the brain for all six patients.
Synchron CEO Tom Oxley said: “The users were able to generate Digital Motor Outputs (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 generalisable across technology platforms, will unlock layers of independence and autonomy for patients.”
Synchron is touted as one of the main rivals to Neuralink, the latter having attracted much of the public attention around BCIs. Elon Musk-owned Neuralink is further behind Synchron in its clinical journey, having implanted only two patients as part of a first-in-human trial.
Synchron is already eyeing up the next clinical phase and is preparing to recruit patients for a large-scale clinical trial ahead of commercial approval, as per Reuters. Synchron is backed by billionaires Jeff Bezos and Bill Gates, among others and raised $75m in Series C financing in December 2022.
