Synchron’s COMMAND Early Feasibility Study of Brain-Computer Interface Completes Enrollment

September 5, 2023—Synchron, an endovascular brain-computer interface (BCI) company developing implantable neural interface technology to restore functionality in patients with severe paralysis, announced completion of patient enrollment in the United States-based COMMAND early feasibility study (EFS).

According to Synchron, the COMMAND EFS, which enrolled six patients, is being conducted under an investigational device exemption from the FDA to assess safety while evaluating quantified efficacy measures of the Synchron Switch motor neuroprosthesis in patients with severe paralysis.

The primary goal of the study is to investigate if the device can be safely implanted into the blood vessels of the brain using neurointerventional procedures. For these patients who can no longer use their hands, the study is additionally designed to evaluate how the BCI may enable use of their thoughts to control digital devices for daily tasks such as texting, emailing, online shopping, and telehealth services.

Synchron advised that the COMMAND study is being conducted at three clinical sites: Mount Sinai Health System in New York, New York; University at Buffalo Neurosurgery in Buffalo, New York; and UPMC, the University of Pittsburgh Medical Center, in collaboration with Carnegie Mellon University College of Engineering in Pittsburgh, Pennsylvania. The study is supported by the National Institutes of Health’s NIH BRAIN Initiative. In March 2023, the company announced commencement of enrollment at the third of the three approved sites—University at Buffalo Neurosurgery.

“Giving patients the option to receive a BCI device without the need for open brain surgery could open up a new frontier in BCI,” commented Raul Nogueira, MD, in Synchron’s press release. “We look forward to analyzing the results of the study and potentially bringing this technology to those in need in the future.” Dr. Nogueira is Endowed Professor & Division Chief of Cerebrovascular Medicine; Director, UPMC Stroke Institute; and Professor of Neurology & Neurosurgery at the University of Pittsburgh.

In January 2023, the company announced the publication of long-term safety results from the SWITCH clinical study. The findings included data from four patients with severe paralysis implanted with Synchron’s first-generation neuroprosthesis device in Australia. The study found that it is possible to use the device to transmit neural signals from inside a blood vessel in the brain over a long-term period without any serious adverse events related to the device. Peter Mitchell, MMed, et al published the findings in JAMA Neurology (2023;80:270-278).