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FAIRFAX, Va. — Researchers demonstrated the success of a fully implantable wireless medical device, the Stentrode™ brain-computer interface (BCI), designed to allow patients with severe paralysis to resume daily tasks — including texting, emailing, shopping and banking online — without the need for open brain surgery. The first-in-human study was published in the Journal of NeuroInterventional Surgery™, the leading international peer-reviewed journal for the clinical field of neurointerventional surgery.
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 a mouse or keyboard. The subjects undertook machine learning-assisted training to control multiple mouse-click actions, including zoom and left click.
“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, PhD, and CEO of Synchron, a neurovascular bioelectronics medicine company that conducted the research. “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.”
Graham Felstead, a 75-year-old man living at home with his wife, has experienced severe paralysis due to amyotrophic lateral sclerosis (ALS). He was the first patient enrolled in the first Stentrode clinical study and the first person to have any BCI implanted via the blood vessels. He received the Stentrode implant in August 2019. With the Stentrode, Felstead was able to remotely contact his spouse, increasing his autonomy and reducing her burden of care. Philip O’Keefe, a 60-year-old man with ALS who works part time, 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 Stentrode device is small and flexible enough to safely pass through curving blood vessels, so 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 that do not require any novel automated robotic assistance.
Preliminary data on the first patient were initially presented at the Society of NeuroInterventional Surgery’s (SNIS) 17th Annual Meeting on August 7, 2020.
About the Journal of Neurointerventional Surgery™
The Journal of NeuroInterventional Surgery™ (JNIS) is a leading peer reviewed journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal was launched in 2009 following growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors and spinal disorders. JNIS is published by BMJ on behalf of SNIS and is also the official journal of ESMINT: The European Society of Minimally Invasive Neurological Therapy, the Interventional Chapter of the Australian and New Zealand Society of Neuroradiology (ANZSNR), CING, the Hong Kong Society of Interventional & Therapeutic NeuroRadiology (HKSITN), the INR Chapter of NRST and the Society of Therapeutic Neurointervention (STNI).
Peer-reviewed / Experimental study / People
NOTES TO EDITORS
The study was funded by Synchron.
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