Trial Planned for Brain Computer Interface as ALS Communication… – ALS News Today

Wyss Center-led research to involve ALS and stroke patients in ‘locked-in’ state
by Marta Figueiredo, PhD |
The Wyss Center for Bio and Neuroengineering is planning to launch a trial of its wireless brain computer interface (BCI), called ABILITY, in enabling people to communicate using only their thoughts.
The study is expected to involve people in locked-in states in which they are fully aware, but unable to move their muscles, including those needed for speech — due to amyotrophic lateral sclerosis (ALS) or a brain stem stroke. These strokes occur when there is a blockage in blood flow to the brain stem, the base of the brain that is connected to the spinal cord.
Supporting a potential trial is a case study in a man in a locked-in state due to fast-progressing ALS.
Trial plans, as well as preclinical data on this BCI and its use, were shared in the white paper “New horizons in neural recording systems.”
“The Wyss Center team and my lab are working together towards the same goal of restoring communication for people who are locked-in,” Nick Ramsey, PhD, with the University Medical Center (UMC) Utrecht Brain Center, in the Netherlands, and a Wyss Center collaborator, said in a center press release.
“We believe that future brain-computer interfaces will go far beyond current technology and have the exciting potential to bring new levels of independence to people with paralysis in their daily life,” added Ramsey, a professor of cognitive neuroscience at the University of Utrecht.
Brain-computer interfaces (BCIs) are designed to restore voluntary motor control to paralyzed people by converting intent-to-move nerve impulses from the motor cortex — a region responsible for voluntary movement — into a digital signal.
These technologies commonly use machine learning to interpret the nerve impulses, collected from tiny electrodes implanted in the brain, and transform them into specific digital actions.
Machine learning is a form of artificial intelligence (AI) that uses algorithms to analyze data, learn from its analyses, and then make a prediction about something.
Wyss Center’s researchers developed NeuroKey, a software platform that is medical grade certified and capable of processing and decoding, in real-time, large amounts of nerve activity data from BCIs.
The software is also equipped with an app that runs an audio feedback speller that prompts the user to select letters to form words and sentences.
In the case study, a NeuroKey-based BCI is being tested in a man with a fast-progressing form of ALS, who advanced to a locked-in state and could no longer use assistive devices to communicate.
Two tiny implants, each containing 64 needle-like electrodes to detect electrical signals from firing nerve cells, were surgically implanted in the man’s motor cortex, a brain region that controls voluntary movement. The signals are transferred to a device on top of the skull that transmits the data to a computer through a wire.
Two-year data showed the system allowed the man to communicate with his family again with just his thoughts.
To reduce the risk of infection, provide increased independence to users, and simplify handling for caregivers, Wyss Center researchers and Ramsey’s team are developing a fully implantable, wireless BCI called ABILITY.
Standing for Active Brain Implant Live Information Transfer sYstem, this BCI is designed for continuous home use and aims to restore communication and movement. Charged through a type of wireless power transfer, the device does not require an implantable battery, and “represents a versatile and user-friendly system,” the researchers wrote in the white paper.
In a first preclinical proof-of-concept trial in sheep, the ABILITY system was found to be generally safe and to allow collection of neural data in real time over a period of months.
“Further extensive studies will be performed to demonstrate that ABILITY meets the very strict regulatory requirements for human use before commencing the planned clinical trials in people,” the researchers wrote.
The planned patient trial is expected to validate the BCI’s use in the home environment and explore new AI algorithms to decode nerve impulses.
These algorithms will first be focused on allowing participants to control a computer as if they were using a mouse or a keyboard. New algorithms will be then created to decode brain signals of imagined or attempted speech into digital speech.
“Together, these features aim to significantly improve quality of life, provide independence, and enable effective and efficient healthcare,” the researchers wrote.
The study “will not only assess the device performance but also the acceptance of implantable BCIs by patients, caregivers, and health care professionals,” the Wyss Center stated in the release.
Data collected through the trial will be used to improve speech translation algorithms, as well as the device’s functionality and use. And because it will be publicly shared, it is expected to help advance brain function knowledge and BCI technology.
“With fully implantable brain-computer interfaces still in their infancy, … we believe that a versatile technology like ABILITY addresses the unmet needs of early adopters and, as a consequence, has the potential to help the BCI market grow,” said George Kouvas, the Wyss Center’s chief technology officer.
Jonas Zimmerman, PhD, senior neuroscientist at the Wyss Center, added that “now is the time to build on [previous BCI-related] achievements, overcome the final hurdles, and bring neural interface technology to those who need it most.”
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