Synchron, a clinical-stage brain-computer interface (BCI) company, has announced positive results from the COMMAND study of the Stentrode BCI device.
COMMAND evaluated the BCI device in six participants for more than 12 months.
Synchron secured the US Food and Drug Administration (FDA) breakthrough device designation for the brain implant in August 2020.
The Bill Gates and Jeff Bezos-backed BCI firm received the FDA Investigational Device Exemption (IDE) approval for the COMMAND trial in 2021.
The study enrolled six patients with severe chronic bilateral upper-limb paralysis unresponsive to therapy. All patients received a BCI implant.
Results showed that all six patients met the primary endpoint of no device-related serious adverse events (SAEs) that led to death or permanent disability during the one-year post-implant evaluation period.
There were no SAEs related to the brain or vasculature over the 12 months.
Additionally, the study demonstrated that brain signals related to motor intent were consistently captured and converted into digital motor outputs. This enabled participants to perform a variety of digital tasks.
Synchron said the Stentrode device was accurately deployed in 100% of cases, achieving target motor cortex coverage for all six patients.
Furthermore, the median deployment time was observed at 20 minutes.
The New York City-based neurotechnology company said the findings demonstrate BCI’s safety profile, stable signal performance, and reliable surgical delivery.
Synchron CEO and founder 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.”
The study was conducted at Mount Sinai Health System in New York City, UB Neurosurgery/Gates Vascular Institute, and University of Pittsburgh Medical Center (UPMC), in collaboration with Carnegie Mellon University College of Engineering.
The Stentrode BCI is implanted in the blood vessel on the brain’s motor cortex via the jugular vein, using a minimally invasive endovascular procedure.
Once implanted, it detects and wirelessly transmits motor intent from the brain. This allows severely paralysed individuals to control personal devices with hands-free point-and-click functionality.
Recently, the BCI company announced the first use of Amazon’s Alexa by one of the patients implanted with the Synchron BCI.
Furthermore, the brain implant is being assessed in the SWITCH clinical trial currently underway in Australia.
