The company recruited six patients in the COMMAND trial, the US FDA investigational device exemption (IDE) study designed to evaluate the safety and efficacy of the company’s permanently implanted BCI device in patients with severe paralysis
Synchron completes enrolment for COMMAND trial. (Credit: Milad Fakurian on Unsplash)
Synchron, an endovascular brain-computer interface (BCI) company, has announced the completion of patient enrolment for the COMMAND trial of its Synchron Switch device.
The company recruited six patients in the COMMAND trial, conducted as the US Food and Drug Administration (FDA) investigational device exemption (IDE) study.
The early feasibility study (EFS) is designed to evaluate the safety while assessing the efficacy of the company’s permanently implanted BCI device in patients with severe paralysis.
Synchron said that the study primarily aims to assess whether its BCI device can be safely implanted into the blood vessels of the brain using neuro-interventional procedures.
For the patients who are unable to move their hands, the study will evaluate how the BCI may use their thoughts to control digital devices for daily tasks such as texting, emailing, online shopping and telehealth services.
Also, it will evaluate the ability of BCI to help patients, who can no longer use their hands, to use their thoughts to control digital devices for their daily tasks.
Synchron CEO and founder Tom Oxley said: “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 United States.
“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 US.”
The COMMAND study enrolled patients at three sites, the Mount Sinai Health System, the University at Buffalo Neurosurgery and the University of Pittsburgh Medical Centre (UPMC).
Synchron is conducting the study in collaboration with Carnegie Mellon University College of Engineering, and with support from the NIH BRAIN Initiative.
The Synchron Switch BCI is designed to be implanted in the blood vessel on the surface of the motor cortex of the brain, through a minimally invasive endovascular procedure.
Once implanted, the device will detect and wirelessly transmit motor intent out of the brain, to help severely paralysed patients control personal devices with hands-free point-and-click.
University of Pittsburgh professor of Neurology and Neurosurgery Raul Nogueira said: “Giving patients the option to receive a BCI device without the need for open brain surgery could open up a new frontier in BCI.”