Synchron Inc announces the initiation of the first clinical trial for the Stentrode, a minimally invasive neural interface technology being 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. BrainOS is a modular training software powered by artificial intelligence that enables patients to control assistive technologies directly through thought.
The Stentrode is designed to record brain activity and stream thoughts wirelessly, and is reportedly the only investigational technology of its kind that does not require open brain surgery, according to the Campbell, Calif-based company in a media release.
“The initiation of this trial is a milestone for the technology industry and points toward a new form of treatment for people with paralysis. There is currently no means for recovery for patients beyond the natural healing process,” says study director Thomas Oxley, MD, PhD.
“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,” adds Oxley, CEO of Synchron and neurointerventionalist, Department of Neurosurgery, Mount Sinai Hospital, New York City.
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, per the release.
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 third-party assistive technologies, the release continues.
[Source(s): Synchron Inc, PR Newswire]