Cognixion seeks ALS patients for clinical trial of BCI headset
Device designed to work with augmented reality to aid communication
Cognixion is recruiting adults with amyotrophic lateral sclerosis (ALS) for a clinical trial testing ONE Axon-R, a wearable headset that combines augmented reality and brain-computer interface technology with an artificial intelligence (AI) application to facilitate communication.
Launched early this year at a single site in the U.S., the clinical trial (NCT06810219) is looking for up to 10 adults with late-stage ALS who need an assistive device to communicate, Cognixion said. Over the three months of the clinical trial, they’ll be asked to perform certain tasks while using ONE Axon-R and its software.
ONE Axon, which the company developed for use as a medical device, has been named a breakthrough device by the U.S. Food and Drug Administration (FDA). The ONE Axon-R version can be used for research only, but findings from the clinical trial are expected to offer insights into the usability of the wearable headset.
“This trial represents a crucial step in understanding how brain-computer interface technology enhanced by AI can be optimized for people with late-stage ALS … and prepares us for a larger pivotal trial required for FDA clearance,” Chris Ullrich, Cognixion’s chief technology officer, said in a company press release.
BCI headset doesn’t require implant
For Rabbi Yitzi Hurwitz, diagnosed with ALS in 2013, wearing Cognixion’s technology as part of the clinical trial was “a powerful light in this challenging journey,” said Rabbi Zvi Boyarsky, a patient advocate who’s been accompanying Hurwitz on his ALS journey.
“There are no words to quantify the joy we all felt when Rabbi Yitzi could communicate and express himself with Cognixion’s technology,” said Boyarsky, director of the Areivim Institute and a supporter of Cognixion’s clinical trial. “It’s a true gift and vital link that maintains the deep human connections that mitigate some of the unbearable suffering” brought on by the disease, he said.
People with ALS gradually lose the ability to speak and control movements, making communication difficult. Because eye movement also becomes affected as the disease progresses, eye-tracking systems cannot be used in these patients.
Several brain-computer interface (BCI) devices are being developed to help patients communicate and control digital devices to gain some lost autonomy. These BCI solutions can detect brain activity and translate it into commands that can be understood by a computer. But most require surgery or at least a minimally invasive procedure to insert an implant that can read the brain’s activity and transmit it to a sensor.
Cognixion’s BCI alternative does not require an implant, relying instead on a wearable headset that uses augmented reality and electroencephalogram, non-invasive brain-sensing technologies.
“Our goal is to bring highly bio-adaptive natural feeling user experiences and disrupt the current state of communication options for those living with the disease with a proven, cutting-edge technology that is delightful to use, and could assist those who need it most without requiring invasive, surgical procedures,” said Ullrich, who’s also the trial’s principal investigator.
By reading the brain’s electrical activity, ONE Axon-R is able to recognize when a patient focuses on an object that represents what the person wants to say.
Using machine learning, a branch of AI that learns from the data over time, it also adapts to how a patient interacts with the environment. With each use, it’s expected to become more efficient at recognizing, and even predicting, what a patient intends to communicate.
Access to communication, “if made available and capable, could transform the quality of life not just for the patient but their family and community, as well,” said Andreas Forsland, Cognixion’s founder and CEO.
The clinical trial’s main goals are to measure how fast information is transferred and to capture the usability of the wearable headset, or the degree to which it’s fit to be used. A secondary goal is to measure the number of words that a patient can speak in one minute.
The study is funded in part by ALS Accel, a fund managed by the ALS Association.
“The ALS Association recognized a unique opportunity to accelerate Cognixion’s non-invasive brain-computer interface for speech generation to the marketplace,” said Keith Gary, PhD, ALS Accel’s managing director. “The technology platform has significant impacts for those affected by ALS, other neurodegenerative diseases, and the research community focused on these areas.”
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