Neuromodulation technologies developer Synchron has implanted the first patient in the clinical feasibility trial of its Stentrode neural interface technology intended to restore communication in patients suffering from severe paralysis.
Stentrode is an investigational, minimally-invasive brain-computer interface, which records brain activity and wirelessly streams thoughts directly from the brain.
The device is powered by the company’s brain-controlled handsfree app brainOS, which helps to translate brain activity into a standardised digital language for controlling apps that restore communication and limb function.
Furthermore, the Synchron Brain-Computer Interface comprises brainPort, an internalised, wireless solution implanted in the chest for neural data transmission.
Stentrode can be placed in the brain via vascular implantation and does not require open-brain surgery.
Synchron CEO Thomas Oxley said: “The commencement of human trials of a commercial brain-computer interface is a major milestone for the industry. By using veins as a naturally-existing highway into the brain, we have been able to reach the clinical stage significantly earlier than other more invasive approaches.”
The clinical trial will assess the safety of Stentrode and brainOS software combination, as well as the stability of captured brain signals to control external communications technologies.
The study, being performed in Melbourne, Australia, is designed for patients with loss of motor function caused by paralysis related to conditions such as spinal cord injury, stroke, muscular dystrophy and motor neuron disease (ALS).
In preclinical studies, Stentrode demonstrated long-term safety and was able to capture specific electrical frequencies from the brain.
Oxley added: “What we learn from the first-in-human clinical trial will be highly valuable in guiding our device design and the clinical protocol for a pivotal trial in the US.”
The company expects to use safety and efficacy data from the clinical trial to finalise the protocol of a pivotal FDA-enabling study to support assessment for marketing approval in the US.