Synchron BCI Trial Meets Safety Goals

Image credit: Kohji Asakawa via Pixabay

In what is the first FDA-approved investigational device exemption (IDE) trial of a permanently implanted brain-computer interface (BCI), neurotech pioneer Synchron has announced promising results from a study assessing the safety and efficacy of its device.

The multi-site COMMAND study tracked six participants over a 12-month period, all of whom had received the Synchron BCI implant due to severe chronic bilateral upper-limb paralysis that was otherwise unresponsive to treatment.

All six patients were reported to have successfully met the study’s primary endpoint of no serious adverse events resulting in death or permanent increased disability due to the device.

Synchron reported that its technology effectively translated brain signals into motor outputs, enabling participants to perform digital tasks, with a median deployment time of 20 minutes.

Co-Principal Investigator, Dr Elad Levy called the results a “a major medical milestone”.

“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 Dr Levy in a statement.

Synchron Chief Executive Officer and Founder, Professor Tom Oxley noted that of significance was the patients’ ability to produce Digital Motor Outputs (DMOs) using the BCI – “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,” said Professor Oxley.

For more information, refer to the press release issued by Synchron.