Synchron Initiates First-ever Clinical Trial to Evaluate Thought-to-Text™ Brain-Computer Interface Technology in Patients with Severe Paralysis

Synchron, Inc. today announced the initiation of the first clinical trial for the Stentrode, a minimally-invasive neural interface technologybeing investigated for restoration of communication in people with severe paralysis. The trial will evaluate the safety of Thought-to-Text technology in patients, by assessing the Stentrode implant in combination with BrainOS software. The Stentrode is designed to record brain activity and stream thoughts wirelessly, and is the only investigational technology of its kind that does not require open brain surgery. BrainOS is a modular training software powered by artificial intelligence that enables patients to control assistive technologies directly through thought.

“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 the study director and CEO of Synchron, Associate Professor Thomas Oxley, MD, PhD, and Neurointerventionalist, Department of Neurosurgery, Mount Sinai Hospital, New York City. “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 trial is a feasibility study to evaluate the safety of the Stentrode as well as to assess the stability of high-fidelity signals from the brain to external communications technologies. 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).

The trial will take place in Melbourne, Australia at The Royal Melbourne and Bethlehem Hospitals.

The Stentrode system is small and flexible enough to safely pass through curving blood vessels in a procedure called cerebral angiography, eliminating the need for open brain surgery. 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.

Pre-clinical studies have demonstrated the Stentrode’s long term safety, as well ability to pick up particular electrical frequencies emitted by the brain. The technology utilizes artificial intelligence and machine learning algorithms that directly interface with and predict brain activity. BrainOS is a suite of stepwise modular training programs that will enable to patients to learn to control digital outputs. This digital output language forms the basis for a human API for patients to control 3^rd party assistive technologies.