Synchron, an endovascular brain-computer (BCI) interface company, today announced the enrollment of the first patient in the US clinical trial, COMMAND, for patients with severe paralysis, at Mount Sinai Hospital in New York. The clinical trial is being conducted under the first investigational device exemption (IDE) awarded by the FDA to a company assessing a permanently implanted BCI. Previous BCI human clinical studies approved by FDA have been conducted in short term experimental settings.

The early feasibility study (EFS), funded by the National Institutes of Health (NIH), will primarily assess safety and begin to explore quantified efficacy measures of Synchron’s Stentrode™ in patients with severe paralysis with the goal of enabling the patient to control digital devices hands-free. Recent studies have demonstrated this technology to be safe in four patients in Synchron’s recent SWITCH clinical trial, unveiled at the American Academy of Neurology last month.

The Stentrode is implanted to the motor cortex of the brain through the jugular vein in a minimally-invasive procedure. Once implanted, it translates brain activity into a standardized digital language to allow patients to complete everyday tasks hands-free, on external devices including texting, emailing, online shopping and accessing telehealth services.

“The COMMAND study progresses Synchron’s technology development through the feasibility stage as we prepare for our pivotal trial. This first patient enrollment under an IDE for a permanently implanted BCI is a major milestone for the entire field, as we advance our solution for the 5 million people in the United States living with paralysis,” said Tom Oxley, M.D., CEO & Founder, Synchron.

Long-term safety data from Synchron’s SWITCH trial conducted in Australia was presented by Professor Bruce Campbell, MD, MS, of the University of Melbourne at the recent American Academy of Neurology Conference. Researchers monitored participants for one year and found the device was safe, with zero adverse events that led to disability or death. The device also stayed in place for all four patients and the blood vessel in which the device was implanted remained open. Following implantation in the SWITCH clinical trial, patients were able to use the Stentrode system unsupervised in their homes to send text messages, conduct online shopping and manage their finances.

Synchron’s flagship technology, the Stentrode, is an endovascular brain implant designed to enable patients to wirelessly control digital devices through thought and improve functional independence. Synchron’s foundational technology, a motor neuroprosthesis (MNP), is implanted via the jugular vein using neurointerventional techniques commonly used to treat stroke, and does not require drilling into the skull or open brain surgery. The system is designed for patients suffering from paralysis as a result of a broad range of conditions, and aims to be user friendly and dependable for patients to use autonomously.

Source: Company Press Release