The study will measure the impact of Cognixion's novel combination of BCI, AI and AR technology on the ability of amyotrophic lateral sclerosis (ALS) patients, who have lost natural speech, to communicate effectively
SANTA BARBARA, CA / ACCESS Newswire / March 12, 2025 / Cognixion, a leading developer of noninvasive Brain-Computer Interface (BCI), Artificial Intelligence (AI) and Augmented Reality (AR) technology, today announced the launch of a clinical trial examining the company's integrated, wearable augmented reality and brain-computer interface (BCI) device, Axon-R, paired with their proprietary AI-powered application to help individuals with amyotrophic lateral sclerosis (ALS) communicate effectively. The study, "Augmented Reality BCI Longitudinal Study for Persons with Late Stage ALS" (NCT06810219), launched January 2025 and is currently enrolling patients in the US.
People with ALS usually experience a progressive loss of communication abilities due to weakness affecting the muscles used for speech, and further loss of effective eye movement. This new modality could address a critical unmet need for the 18,000 to 30,000 people in the US who suffer from the disease, with 80-95% of these patients eventually progressing to the point of no longer being able to communicate using natural speech, or use their eyes to control eye tracking systems, which is the current standard of care that ALS patients quickly become unable to use effectively or at all.
Cognixion's personalized generative AI communication software in the Axon-R BCI platform will restore the ability to communicate for individuals who have lost the capability to do so through conventional means such as speech, facial movement or eye glances. The technology uses augmented reality and EEG non-invasive brain sensing technologies to deliver a hyper-intuitive generative AI interface that supports interpersonal, rapid conversations and turn-taking with partners in real-time, exceeding the typical words per minute text to speech technologies available today.
The study, which is partially funded by ALS Accel (a subsidiary of the ALS Association), will assess how effectively individuals with ALS can communicate using the Axon-R system and the generative AI conversational application. It will track participants' ability to learn to use BCI over time and measure their progress. The study will also evaluate which input methods (BCI, eye-tracking) work best for enabling communication and identify how to adapt and optimize BCI inputs for each individual.
"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, M.Sc., 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."
The loss of communication capability significantly impacts an ALS patient's quality of life, often leading to feelings of isolation, frustration, and a decreased sense of control. Patients who lose their ability to communicate lose access to a large part of human interaction and the ability to maintain social connections. The impact on patients increases as the disease progresses, and verbal communication becomes increasingly difficult. The loss of independence, agency and "aliveness" of the individual's presence in everyday living has an impact on that person's family and immediate circle of friends and community.
"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.
"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., Managing Director of ALS Accel. "The technology platform has significant impacts for those affected by ALS, other neurodegenerative diseases, and the research community focused on these areas."
Cognixion clinical trial findings are expected to refine the usability of the Axon-R device communication software and provide evidence about the effectiveness of this combined AR/BCI/AI approach for a viable new communication pathway for people with ALS.
Axon-R users will be able to communicate at near conversational speed, compared to the slow, painstaking words per minute produced by eye tracking, traditional BCI assistive communication systems and analog methods such as physical letter boards. The ability provided by Axon-R and the generative AI communication software will significantly increase the communication output speed and nuance and personal identity for severely disabled individuals.
One patient, Rabbi Yitzi Hurwitz, was diagnosed with ALS in 2013. Rabbi Zvi Boyarsky, Patient Advocate and Director of Areivim Institute, a supporter of the Cognixion ALS clinical trial, has been a figure in ALS patient Rabbi Hurwitz's life from his diagnosis to his enrollment in the clinical trial. He shared, "There are no words to quantify the joy we all felt when Rabbi Yitzi could communicate and express himself with Cognixion's technology. It's a true gift and vital link that maintains the deep human connections that mitigate some of the unbearable suffering and is a powerful light in this challenging journey."
Cognixion is conducting the study in the United States, in alignment with community support organizations, such as Areivim Institute. The company is also collaborating withother healthcare professionals in its network to identify prospective participants for the study.
The study is currently accepting additional participants. Interested individuals with ALS and their caregivers can learn more by contacting clinicaltrials@cognixion.com.
About the Cognixion ONE™ Axon-R™
The Cognixion ONE Axon-R enables precise measurement and modulation of brain activity through visual stimuli, biofeedback, and neurofeedback. This wearable device offers up to 16 channels of research-quality physiological data and an integrated steady state visually evoked potential classifier. It also includes a robust Software Development Kit for researchers interested in integrating neural data into immersive AR applications for a variety of health and scientific uses - ranging from assistive technology to digital diagnostics, therapeutics, remote monitoring and telehealth applications.
Researchers equipped with the Axon-R can expand beyond the confines of standard laboratories, engaging in immersive and interactive studies that leverage multi-modal interaction that combine a variety of sensors, augmented reality, and brain sensing in just about any setting, indoors and outdoors.
About ALS Accel
ALS Accel is accelerating the ALS Association mission by expediting the commercialization of adaptive/assistive technologies, medical devices, diagnostics, and repurposed drugs. ALS Accel makes targeted investments to de-risk select, later-stage technologies ultimately raising their visibility to investors. For more information, contact Dr. Keith Gary at keith.gary@als.org.
About the ALS Association
The ALS Association is the largest ALS organization in the world. The ALS Association funds global research collaborations, assists people with ALS and their families through its nationwide network of care and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association is working to make ALS a livable disease while urgently searching for new treatments and a cure. For more information about the ALS Association, visit our website at www.als.org.
About Areivim Institute
Areivim is dedicated to addressing critical societal needs, with a primary mandate of providing comprehensive medical support and enhancing quality of life for those facing challenges. Our partnership with Cognixion aligns perfectly with this mission, as their innovative technology empowers individuals with ALS to regain their voice and independence. We're proud to support initiatives that not only advance medical care but also significantly improve the daily lives of those we serve, embodying the compassion and progress that are central to Areivim's work.
About Cognixion
Cognixion is a leader in brain-computer, augmented reality, artificial intelligence and natural user interface technology. The company is dedicated to improving the lives of individuals with severe motor impairments by providing cutting-edge patented technology that allows them to independently communicate and restore physical interactions with the world around them. The Cognixion ONE™ device is the company's flagship product, and it has already received significant recognition for its design and potential to transform the lives of individuals with severe motor impairments. Cognixion has received FDA Breakthrough Device Designation for its derivative version called, Cognixion ONE Axon. The work described in this study is built up the Cognixion ONE Axon-R, which is a version of the Axon made specifically for research purposes, and is not currently cleared by the FDA as a medical device.
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SOURCE: Cognixion
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