PHOTO CAPTION: The Stentrode brain-computer interface, implanted via procedures commonly used for neurovascular stents, is designed to self-expand and grow into the blood vessels wall without obstructing blood flow. (Photo courtesy of Synchron Inc)
Two ALS patients, implanted with the Stentrode brain-computer interface via the jugular vein and without the need for open brain surgery, successfully controlled their personal computer through direct thought, according to a study published in the Journal of NeuroInterventional Surgery.
The study, reportedly the first one performed in humans, demonstrates the successful use of the Stentrode brain-computer interface (BCI), or neuroprosthesis, to enable patients with severe paralysis to resume daily tasks, including texting, emailing, shopping and banking online, through direct thought, and without the need for open brain surgery, Synchron — a neurovascular bioelectronics medicine company and developer of the Stentrode — announces.
The study is reportedly the first to demonstrate that a BCI implanted via the patient’s blood vessels is able to restore the transmission of brain impulses out of the body, and did so wirelessly. The patients were able to use their impulses to control digital devices without the need for a touchscreen, mouse, keyboard or voice activation technology, a media release from Synchron Inc notes.
A Breakthrough Moment
“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.
“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.”
— Thomas Oxley MD PhD, founding CEO, Synchron
The patients enrolled in the study utilized the Stentrode neuroprosthesis to control the Microsoft Windows 10 operating system, in combination with an eye-tracker for cursor navigation, without the need for a mouse or keyboard. The subjects undertook machine learning-assisted training to control multiple mouse click actions, including zoom and left click.
The first two patients achieved an average click accuracy of 92% and 93%, respectively, and typing speeds of 14 and 20 characters per minute with predictive text disabled. The patients used the neuroprosthesis to resume daily tasks independently, including text messaging, online shopping, and managing finances. Following implantation and training, patients commenced unsupervised home use of the system from day 86 and day 71, respectively.
The First Two Users Share Their Experiences
“Using the Stentrode has been life-altering. 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.”
— 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
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.
By using the Stentrode, he 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.
“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.
“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.”
— Nicholas Opie, associate professor and co-head of the vascular bionics laboratory at the University of Melbourne and founding CTO of Synchron
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, the release continues.
Offers New Therapies to Patients
“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.
“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.”
— Professor Peter Mitchell, Director of Neurointervention, The Royal Melbourne Hospital, who performed the first clinical implantations of the Stentrode device
As the Stentrode device is small and flexible enough to safely pass through curving blood vessels, the implantation procedure is similar to that of a pacemaker and does not require open brain surgery. Entry through the blood vessels may reduce risk of brain tissue inflammation and rejection of the device, which has been an issue for techniques that require direct brain penetration. Implantation is conducted using well-established neurointerventional techniques which do not require any novel automated robotic assistance.
Stentrode has been granted Breakthrough Device designation from the US Food and Drug Administration (FDA). The safety and efficacy data from this feasibility study will be used to finalize protocols for a future FDA-approved trial that will guide evaluation for US marketing approval, per the release.
Preliminary data on the first patient were initially presented at the Society of NeuroInterventional Surgery (SNIS) 17th Annual Meeting on August 7, 2020. It is hoped that future indications for use, currently being explored by Synchron, will expand the brain-computer interface market.
[Source(s): Synchron Inc, Business Wire]
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