Synchron’s Stentrode Endovascular Brain-Computer Interface to Be Evaluated in COMMAND EFS

May 4, 2022—Synchron, Inc., an endovascular brain-computer (BCI) interface company, announced the commencement of the United States COMMAND early feasibility study (EFS) of the Stentrode motor neuroprosthesis (MNP) for patients with severe paralysis. The first patient in the COMMAND was enrolled at Mount Sinai Hospital in New York, New York.

According to the company, the COMMAND EFS will assess the Stentrode MNP, which is a permanently implanted BCI. It will primarily assess safety and begin to explore quantified efficacy measures of the Stentrode in patients with severe paralysis with the goal of enabling the patient to control digital devices hands-free.

The study is funded by the National Institutes of Health and is being conducted under an FDA investigational device exemption (IDE). Previous BCI human clinical studies approved by the FDA have been conducted in short-term experimental settings, noted the company.

Additionally, the company advised that long-term data from the SWITCH first-in-human study demonstrated this technology to be safe in four patients. “Long-Term Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis: Results of SWITCH, a First-in-Human Study” by Professor Bruce Campbell, MBBS, et al was presented at AAN 2022, the American Academy of Neurology annual meeting that was held virtually April 24-26 and in Seattle, Washington on April 2-7. The Emerging Sciences abstract is available online.

The SWITCH investigators monitored patients for 1 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. After 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, stated the company.

Synchron’s Stentrode endovascular brain implant is designed to enable patients to wirelessly control digital devices through thought and improve functional independence. The device is implanted in the motor cortex of the brain via the jugular vein using neurointerventional techniques commonly used to treat stroke and does not require drilling into the skull or open brain surgery.

After being implanted, the device 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 system is designed for patients with paralysis as a result of a broad range of conditions and is intended to be user-friendly and dependable for patients to use autonomously, stated the company.

Tom Oxley, MD, who is CEO & Founder of Synchron, stated in the press release, “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.”