Synchron Inc. has successfully completed the first brain implantation of the Stentrode as part of a clinical feasibility trial. The first-in-human study is designed to assess the potential of this technology to restore communication in patients who suffer from severe paralysis, including those with amyotrophic lateral sclerosis (ALS).
The Stentrode is a minimally invasive technology that is part of the Synchron Brain-Computer Interface. It is the first implantable device currently under investigation that does not need to be inserted via open brain surgery.
The Stentrode was developed as a way to register brain signals and then stream thoughts straight from the brain.
The technology used to develop Stentrode relies on an innovative brain-controlled, hands-free application platform known as brainOS, which helps translate activity within the brain into a digital language that is used to manipulate apps that reinstate communication and limb function.
Furthermore, brainPort, which works wirelessly, is embedded within the chest and is able to transmit high-resolution data. BrainPort forms the final element of the Brain-Computer Interface developed by Synchron.
“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,” said Thomas Oxley, MD, PhD, CEO of Synchron, in a press release.
The trial of Stentrode combined with brainOS software will help asses the safety and feasibility of signals attained from the brain to manipulate technologies that can help patients communicate externally.
This clinical trial, taking place in Melbourne, Australia, will include patients who have suffered loss of motor function from paralysis because of several different conditions, including ALS.
Pre-clinical research has shown that the Stentrode is associated with long-term safety and can register particular electrical frequencies transmitted by the brain. Such results have been published in a series of journals, including Nature Biotechnology and Nature Biomedical Engineering.
Much like the technique used by doctors to implant cardiac pacemakers, the Stentrode is transported to the brain through blood vessels.
Because the Stentrode is tiny and malleable, it is able to go through blood vessels that curve in order to reach its location without requiring brain surgery. Researchers suggest that this procedure can help decrease the chances of brain tissue rejection of the device, which has been an issue with other implants.
“By reimagining the concept of the operating system, we have designed our technology platform to enable a completely hands-free user experience. What we learn from the first-in-human clinical trial will be highly valuable in guiding our device design and clinical protocol for a pivotal trial in the U.S.,” Oxley said.
Synchron is in talks with the United States Food and Drug Administration (FDA) to discuss potential regulatory strategies for the device. The FDA has helped plan the clinical trial as a first step on the pathway to approval.
The data obtained from these initial patients will be used to establish the final protocol that will help guide a pivotal clinical trial, the data from which will be used for eventual U.S. marketing approval.
“Our bodies can only carry so much information out of the brain. This industry is going to unlock the brain’s computational power in ways that are hard to imagine now. This is just the beginning,” Oxley said.