Brain-computer interface allowing ‘locked-in’ ALS patients to communicate earns European approval

Brain-computer interface allowing ‘locked-in’ ALS patients to communicate earns European approval

The dream of a device converting nonverbal amyotrophic lateral sclerosis (ALS) patients’ brainwaves into speech could finally become a reality now that a neural signal processing platform designed to do just that has received regulatory clearance in Europe.

The NeuroKey platform was developed by the Wyss Center for Bio and Neuroengineering, a nonprofit research institute in Switzerland. Though researchers continue to develop the platform with a goal of one day using brain signals to restore movement and collect health data like body temperature and blood flow, they’ve already received a CE mark for NeuroKey’s ability to enable communication.

NeuroKey works by analyzing high-channel-count, high-frequency signals collected by electrodes implanted on the brain and wired to a computer. The platform’s algorithm identifies the intention behind those signals and helps users piece together words and sentences using an automated speller or a simple yes/no prompt.

While the software continuously learns and updates itself based on its work translating a user’s brainwaves into words, it also provides audio feedback to users to help make their brain activity more compatible with the NeuroKey algorithms.

The platform is designed for home use and was created to be easily launched and calibrated by family members and caregivers. It has already been deployed in the home in a single case study of a patient who is completely locked in—meaning he is unable to speak or move—due to a fast-progressing form of ALS.

“We developed NeuroKey because we couldn’t find a software platform that met our needs,” said David Ibáñez Soria, Ph.D., the Wyss Center’s program manager for NeuroKey.

He continued, “We needed software that could handle large data streams in real time from hundreds of channels recording from the human brain. We also needed the flexibility to record from various types of electrodes. With our first application now CE marked, we look forward to bringing our solution to more clinical settings.”

Those settings go beyond treating only ALS patients, with potential use cases in a variety of movement- and communication-limiting conditions such as stroke, spinal cord injury, late-stage muscular sclerosis, late-stage Parkinson’s disease and severe cerebral palsy.

The NeuroKey platform is currently being integrated with Wyss’ ABILITY system, in which an implanted device wirelessly transmits brain signals to an external wearable device, which then uploads those data to a computer via wired connection.

The ABILITY brain-computer interface is currently being tested to restore walking and grasping abilities in stroke and spinal cord injury patients and to enable communication in those locked in with ALS, as well as to assist in neuromodulation treatments.

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