Cognixion announced today that it launched a clinical trial evaluating its integrated, wearable augmented reality and BCI device.

The clinical trial evaluates the Axon-R device paired with a proprietary AI-powered application. This combination could help individuals with amyotrophic lateral sclerosis (ALS) communicate effectively.

Cognixion’s study launched in January and investigators currently have enrollment underway in the U.S.

The Santa Barbara, California–based company designed its personalized, generative AI communication software in the Axon-R brain-computer interface (BCI) platform to restore the ability to communicate for individuals who have lost the capability to do so through conventional means like speech, facial movement or eye glances.

Cognixion’s technology uses augmented reality and EEG non-invasive brain sensing technologies. It delivers a hyper-intuitive generative AI interface that supports interpersonal, rapid conversations and turn-taking in real-time. The platform exceeds the typical words-per-minute text-to-speech technologies available today.

“Communication access is a root cause issue that, 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, founder and CEO of Cognixion.

More about the Cognixion BCI study

ALS Accel (a subsidiary of the ALS Association) partially funds the study, according to a news release. Investigators aim to assess how effectively individuals with ALS can communicate using Axon-R and the generative AI application.

The study tracks participants’ ability to learn to use BCI over time and measures their progress. It also evaluates which input methods (BCI, eye-tracking) work best for enabling communication. The company wants to identify how to adapt and optimize BCI inputs for each individual.

Cognixion expects clinical trial findings to refine the usability of its device communication software. The company hopes to acquire evidence on the combined approach’s effectiveness as a viable communication pathway for those with ALS.

“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 other debilitating conditions rendering individuals cognitively able but completely locked in their bodies, and prepares us for a larger pivotal trial required for FDA clearance,” said Chris Ullrich, principal investigator and chief technology officer at Cognixion. “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.”

Cognixion’s study could be yet another sign of the continuing growth of the BCI space. The company is featured on our 2023 list of five BCI companies you should familiarize yourself with. (We also have a 2022 list of seven of those companies that you should know and another list of five compiled in 2024).

Companies like Neuralink, Synchron, and Blackrock Neurotech have long been seen as the leaders, but a number of companies aim to be the first to bring a BCI to market. Analysts said last year that they see a massive market opportunity for the technology.