Synchron said it has begun the first clinical trial for its neural interface technology designed to restore communication to people with severe paralysis.
The trial will measure the safety of the company’s “thought-to-text” technology by assessing its Stentrode implant in combination with BrainOS software, as well as the stability of high-fidelity signals from the brain to external communications technologies.
Stentrode was designed to be small and flexible enough to safely pass through curving blood vessels in a procedure called cerebral angiography, eliminating the need for open brain surgery, according to Campbell, Calif.-based Synchron. By using blood vessels to deliver the technology to the brain, the technique may reduce risk of brain tissue rejection of the device, which has been a significant problem for other techniques, the company said. BrainOS is a modular training software powered by artificial intelligence that enables patients to control assistive technologies directly through thought.
Synchron has received approval to recruit five patients with loss of motor function from paralysis due to a range of conditions, including spinal cord injury, stroke, muscular dystrophy, or motor neuron disease (ALS). Pre-clinical studies have demonstrated Stentrode’s long term safety, as well as its ability to pick up particular electrical frequencies emitted by the brain, the company said.
“The initiation of this trial is a milestone for the technology industry and points towards a new form of treatment for people with paralysis. There is currently no means for recovery for patients beyond the natural healing process,” said Synchron CEO and neuro-interventionalist Dr. Thomas Oxley in a prepared statement. “The coupling of the Stentrode with our BrainOS technology represents a potential solution to enable people to regain control of their world, but with digital means. For people who have lost the ability to communicate, this technology could be life-changing.”
The Stentrode technology platform has been funded in part by grants from the U.S. Defense Advanced Research Projects Agency (DARPA) and the U.S. Department of Defense. It was initially developed through collaboration at the University of Melbourne, The Florey Institute of Neuroscience and Mental Health and the Royal Melbourne Hospital in Australia. The trial will take place in Melbourne at The Royal Melbourne and Bethlehem Hospitals.