Human communication

Trial planned for brain-computer interface as a communication aid for ALS | Research to engage ALS, stroke patients in locked state

The Wyss Center for Bio and Neuroengineering plans to launch a trial of its wireless brain-computer interface (BCI), called ABILITY, to allow people to communicate using only their thoughts.

The study should involve people in locked states in which they are fully conscious, but unable to move their muscles, including those needed for speech – due to amyotrophic lateral sclerosis (ALS) or stroke. These strokes occur when there is a blockage of blood flow to the brainstem, 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-down state due to rapidly progressing ALS.

Trial plans, along with preclinical data on this BCI and its use, have been shared in the white paper.”New horizons in neural recording systems.”

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“The Wyss Center team and my lab are working together with the same goal of restoring communication for those locked down,” Nick Ramsey, PhD, of the University Medical Center (UMC) Utrecht Brain Center, the Netherlands, and a collaborator of the Wyss Center, said in a press release from the center.

“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 paralyzed people in their daily lives,” added Ramsey, Professor of Cognitive Neuroscience. at the University of Utrecht.

Center’s brain-computer interface research helped ALS patient communicate

Brain-computer interfaces (BCIs) are designed to restore voluntary motor control to paralyzed individuals by converting movement intention nerve impulses from the motor cortex – a region responsible for voluntary movement – ​​into a digital signal.

These technologies commonly use machine learning to interpret 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 researchers have developed NeuroKey, a certified medical-grade software platform capable of processing and decoding large amounts of BCI nerve activity data in real time.

The software also comes equipped with an app that performs audio feedback spelling that prompts the user to select letters to form words and sentences.

In the case study, a NeuroKey-based BCI is tested in a man with a rapidly progressive form of ALS, who reached a locked state and could no longer use assistive devices to communicate.

Two tiny implants, each containing 64 needle-like electrodes to detect electrical signals from triggering nerve cells, have been surgically implanted into the man’s motor cortex, a region of the brain that controls voluntary movement. The signals are transferred to a device at the top of the skull which transmits the data to a computer via a wire.

Data over two years showed that the system allowed the man to communicate with his family again with only his thoughts.

To reduce the risk of infection, provide increased independence for 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 via 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 an initial proof-of-concept preclinical trial in sheep, the ABILITY system was found to be generally safe and allowed for the collection of real-time neural data over a period of months.

The goal of the trial is to bring “interface technology to those who need it most”

“Further extensive studies will be conducted to demonstrate that ABILITY meets very stringent regulatory requirements for human use before commencing planned human clinical trials,” the researchers wrote.

The planned patient trial should validate the use of BCI in the home environment and explore new AI algorithms for decoding nerve impulses.

These algorithms will first aim to allow participants to control a computer as if they were using a mouse or keyboard. New algorithms will then be created to decode brain signals from imagined or attempted speech into digital speech.

“Together, these features aim to significantly improve quality of life, ensure independence, and enable effective and efficient health care,” the researchers wrote.

The study “will not only assess device performance, but also the acceptance of implantable BCIs by patients, caregivers and healthcare professionals,” the Wyss Center said in the release.

Data collected from the trial will be used to improve the voice translation algorithms, as well as the functionality and usability of the device. And because it will be shared publicly, it should help advance knowledge about brain function 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, therefore, has the potential to help the BCI market to grow,” said George Kouvas, chief technology officer of the Wyss Center.

Jonas Zimmerman, PhD, senior neuroscientist at the Wyss Center, added that “now is the time to build on [previous BCI-related] achievements, overcoming remaining hurdles and bringing neural interface technology to those who need it most.