Synchron, an endovascular brain-computer interface (BCI) company, announced the first human BCI implant in the United States. This procedure represents a significant technological milestone for scalable BCI devices and is the first to occur in the U.S. using an endovascular BCI approach, which does not require invasive open-brain surgery.
The procedure was performed at Mount Sinai West in New York, led by clinical investigator Shahram Majidi, MD, assistant professor of neurosurgery, neurology and radiology at the Icahn School of Medicine at Mount Sinai. The procedure was performed in the angiography suite with a minimally invasive, endovascular approach. Mount Sinai’s Department of Rehabilitation and Human Performance helped coordinate the procedure.
The procedure marks the first U.S. patient implant in Synchron’s COMMAND trial, which is being conducted under the first investigational device exemption (IDE) awarded by the FDA to a company assessing a permanently implanted BCI. The U.S.-based trial is being conducted with support from the NIH Neural Interfaces Program.
The COMMAND study will assess the safety and efficacy of the company’s motor BCI technology platform, including the Stentrode, in patients with severe paralysis with the goal of enabling the patient to control digital devices hands-free. Study outcomes include the use of brain data to control digital devices and achieve improvements in functional independence.
The Stentrode is implanted within the motor cortex of the brain via the jugular vein in a minimally-invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent using a proprietary digital language to allow severely paralyzed patients to control personal devices with hands-free point-and-click. The trial will assess the impact of everyday tasks such as texting, emailing, online shopping and accessing telehealth services, and the ability to live independently. The FDA granted Breakthrough Device designation to Synchron in August 2020.
Synchron will continue to advance enrollment in its COMMAND trial as the industry-first FDA-approved clinical trial for a permanently implanted BCI in the U.S. Recently reported long-term safety results have demonstrated this technology to be safe in four patients out to 12 months in Synchron’s SWITCH trial in Australia, as reported at the 2022 American Academy of Neurology Conference.