Synchron has announced completion of patient enrolment in the USA-based COMMAND trial assessing the company’s endovascular brain-computer interface (BCI) technology.
“Giving patients the option to receive a BCI device without the need for open brain surgery could open up a new frontier in BCI,” said Raul Nogueira (University of Pittsburgh Medical Center [UPMC] Stroke Institute, Pittsburgh, USA). “We look forward to analysing the results of the study and potentially bringing this technology to those in need in the future.”
The COMMAND trial enrolled a total of six patients and is being conducted under the first investigational device exemption (IDE) awarded by the US Food and Drug Administration (FDA) to a company assessing a permanently implanted BCI, according to Synchron.
The early feasibility study is evaluating safety while also assessing quantified efficacy measures of the Synchron Switch motor neuroprosthesis in patients with severe paralysis.
The primary goal of the study is to adjudge if the device can be safely implanted into the blood vessels of the brain using neurointerventional procedures, but it has also been designed to evaluate how the BCI may enable the use of patients’ thoughts to control digital devices for daily tasks like texting, emailing, online shopping and telehealth services.
The COMMAND study is being conducted at three US clinical sites: Mount Sinai Health System in New York City; University at Buffalo Neurosurgery in Buffalo; and UPMC—in collaboration with Carnegie Mellon University College of Engineering—in Pittsburgh. The study is being carried out with support from the National Institutes of Health (NIH) BRAIN initiative.
“We would like to thank everyone who partnered with us to complete this important clinical trial enrolment milestone, especially patients and caregivers as well as the physicians and research staff at our clinical sites in the USA,” said Tom Oxley, CEO and founder, Synchron. “We look forward to announcing the results from our COMMAND study and will continue to advance development of Synchron Switch towards a pivotal clinical trial in the USA.”
