Synchron’s CEO, Thomas Oxley, MD, Ph.D., describes the implant as “Bluetooth for the brain. The big difference between what we have done with what previous approaches have done is that we do not put any needles into the brain or on top of the brain. The device stays inside the blood vessel.”
The study findings published in the Journal of NeuroInterventions Surgery specifically show the device’s ability to enable patients with severe paralysis to resume daily tasks such as texting, emailing, shopping and banking online all through direct though without the need for open brain surgery.
This study is the first to demonstrate that a BCI that has been transplanted via patient blood vessels is able to restore the transmission of brain impulses out of the body wirelessly; patients successfully used their impulses to control digital devices without using a touchscreen, mouse, keyboard or voice-activated technology.
“This is a breakthrough moment for the field of brain-computer interfaces. We are excited to report that we have delivered a fully implantable, take home, wireless technology that does not require open brain surgery, which functions to restore freedoms for people with severe disability,” said Thomas Oxley MD Ph.D., founding CEO, Synchron. “Seeing these first heroic patients resume important daily tasks that had become impossible, such as using personal devices to connect with loved ones, confirms our belief that the Stentrode will one day be able to help millions of people with paralysis.”
Using the Stentrode neuroprosthesis device patients controlled the Microsoft Windows 10 operating system, in combination with an eye tracker for cursor navigation without a mouse or keyboard. Patients undertook machine learning assisted training to control multiple mouse click actions, and the first 2 patients were able to achieve an average click accuracy of 92 and 93% with typing speeds of 14 and 20 characters per minute with predictive text disabled. The device was used to resume daily tasks independently following implantation and training to commence unsupervised home use of the system from day 86 and 71.
“Using the Stentrode has been life-altering,” said Graham Felstead, the first patient enrolled in the first Stentrode clinical study and the first person to have any BCI implanted via the blood vessels. “The device has allowed me to be productive again, including shopping, banking, and delegating tasks among the Rotary Club members with whom I volunteer. It’s incredible to gain this level of independence back.” By using the Stentrode, Graham was able to achieve his goals of remotely contacting his spouse, increasing his autonomy and reducing her burden of care. He was able to maintain contact with other family members, medical professionals and people in his community. Graham, a 75-year-old man living at home with his wife, has experienced severe paralysis due to amyotrophic lateral sclerosis (ALS), and received the Stentrode implant in August 2019. He continues to use it today.
“It is truly amazing, and very rewarding, to see the participants use the Stentrode to control a computer with their minds, independently and at home,” said Nicholas Opie, associate professor and co-head of the vascular bionics laboratory at the University of Melbourne and founding CTO of Synchron. “The trial participants have been fantastic, and my colleagues and I are truly honored to make a difference in their lives. I hope others are inspired by their success.”
The second participant, Philip O’Keefe, a 60-year-old man with ALS, working part-time and living at home with his wife and two children, was able to control computer devices to conduct work-related tasks and other independent activities after receiving the Stentrode in April 2020. Functional impairment to his fingers, elbows, and shoulders had previously inhibited his ability to engage in these efforts.
“While the Stentrode is a completely novel concept and design, the procedure to implant it draws upon techniques that I use on a daily basis and which have become routine in our industry. The Stentrode technology exemplifies the progress and potential of neurointervention departments to deliver new therapies to patients,” said Professor Peter Mitchell, Director of Neurointervention, The Royal Melbourne Hospital, a pioneering neurointerventionalist who performed the first clinical implantations of the Stentrode device. “The intricacies of the brain have always fascinated me and enabling a patient with paralysis to continue to use their mind in a productive way is immensely rewarding.”
This device is small and flexible enough to safely pass through curving blood vessels, the implantation procedures are similar to that of a pacemaker and does not require open brain surgery. This may reduce the risk of brain tissue inflammation and rejection of the device which has been an issue for devices in the past using techniques that require direct brain penetration.
The device is delivered into the jugular vein, using a catheter to thread the device upward until it is adjacent to the motor cortex. Once implanted the device is able to pick up nearby brain activity using tiny electrodes that dot its surface. A second device embedded into the patient’s chest transmits data wirelessly to a computer or other smart device that is running the machine learning software which in turn converts that information into computer commands and functions.
“Other approaches to brain-computer interfaces have been focused on high data rates, which create technical barriers to clinical translation. Synchron has focused on building a product that measurably improves patients’ lives. Our first-to-market product will focus on smart device control using brain impulses, without the need for the use of the hands. This alone has potential to address an unmet market need in 30 million patients in advanced economies,” added Oxley.
The US FDA granted Stentrode Breakthrough Device designation, and the safety and efficacy data from this feasibility study will be used to finalize the protocols for a future FDA approval trial that will eventually guide the evaluation of the device for American marketing approval.
The neurovascular bioelectronic medicine company presented preliminary data on the first patient at the Society of NeuroInterventional Surgery Annual Meeting In August 2020, and the long term safety as well as ability to pick up specific electrical frequencies emitted by the brain was established by preclinical studies that were published in Nature Biotechnology, Nature Biomedical Engineering and the Journal of Neurosurgery.
Eventually, the company plans to use this technology to help paralyzed patients control robotic limbs in order to provide them even more freedom and have an even bigger positive impact on the everyday lives of people who use it.
