American Marconi Wireless News - Cognixion Launches Clinical Study Integrating Non-Invasive Brain-Computer Interface Technology

Study to accelerate access to brain-computer interface technology, using Apple Vision Pro, for people with ALS, spinal cord injury (SCI), stroke or traumatic brain injury (TBI)

SANTA BARBARA, CA / ACCESS Newswire / October 1, 2025 / Cognixion, a leader in non-invasive Brain-Computer Interface (BCI), Artificial Intelligence (AI), and Augmented Reality (AR) technology, today announced a clinical study integrating its EEG-based brain-computer interface with Apple Vision Pro. The study will evaluate how Cognixion's NucleusTM bio-sensing hub and advanced EEG montage - when used with Apple Vision Pro's accessibility features such as Eye Tracking and Dwell Control - can enable new ways for individuals to communicate and interact using combinations of brain signals, eye gaze, or head pose, without the need for surgery. The first and most important outcome is enabling natural, conversational communication between participants and their families, caregivers, and communities.

By combining Cognixion's expertise in neurotechnology and Artificial Intelligence with the accessibility features available on Apple Vision Pro, the study will assess new assistive pathways to enable faster, more natural communication and computer interaction for people with speech and mobility challenges. This is especially imperative for people living with conditions including amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), stroke-related speech impairments (excluding aphasia), and traumatic brain injury (TBI). Details are available on ClinicalTrials.gov (keyword: Cognixion). The study will measure how these combined technologies expand access to everyday communication without surgery. Patients can enroll now and the study is expected to run through April 2026.

In the U.S., there are more than 14 million people living with these conditions that are chronically disabled, and every year, almost 1 million more are diagnosed with these conditions. Based on the severity of these conditions, more than 750,000 Americans may have limited access to solutions for basic speech communication. The severity of these neurological impairments leaves patients awake and aware, but completely unable to communicate with family and loved ones.

As with all Apple products, powerful accessibility features have been built into visionOS, offering systemwide features like AssistiveTouch, Switch Control and Live Speech to Apple Vision Pro users. By leveraging accessibility features on Apple Vision Pro, including Eye Tracking and Dwell Control, with Cognixion's non-invasive, AI mediated neural input methods, the study aims to evaluate new forms of hands-free, voice-free interaction for individuals with little or no voluntary motor control.

"Apple has set a global standard by making accessibility integral to every device, and Apple Vision Pro extends that commitment to spatial computing," said Andreas Forsland, CEO of Cognixion. "By exploring how Cognixion's non-invasive BCI technology and AI applications can work with Apple's accessibility features, we hope to unlock new levels of independence and connection for people living with ALS, spinal cord injuries, stroke, and traumatic brain injuries. Our focus is on improving lives today without requiring surgery or tethered systems."

Cognixion will also validate use cases in Assisted Reality applications, ranging from controlling mobility devices to accessing entertainment, education, and work - all through a seamless, non-invasive interface designed for real-world independence.

Cognixion's mission is centered on creating real-world value for people with communication and mobility impairments. By combining Apple's powerful accessibility features with Cognixion's non-invasive neurotechnology, the study underscores a shared belief: accessibility is not an add-on, but a fundamental right.

This study marks one of the first clinical explorations of a non-invasive EEG-based BCI working with Apple Vision Pro, aiming to help individuals with significant disabilities not only communicate, but thrive, maintaining independence and agency in daily life.

"This study is about understanding the patient experience-what happens when advanced accessibility features meet new neural input methods," said Chris Ullrich, Chief Technology Officer at Cognixion and principal investigator for the clinical trial. "We are committed to working closely with each participant, learning from their lived experiences, and translating that into meaningful, delightful solutions. Apple Vision Pro offers an intuitive user interface, and our goal is to leverage Cognixion's brain-sensing and AI technologies to better support millions of people affected by speech and mobility challenges."

Persons interested in participating should contact Cognixion at [email protected], and include "Cognixion-spatial computing study" in the subject line.

This study relates to a Cognixion medical device that has not yet been cleared by the FDA. The device is not available for sale and does not diagnose or treat any medical condition. Cognixion expects to follow this feasibility study with a pivotal trial in 2026 with the goal of achieving FDA clearance.

About Cognixion

Cognixion is a neurotechnology company pioneering accessible brain-computer interfaces for communication, accessibility, and immersive computing. Headquartered in Santa Barbara, California, Cognixion develops the Axon-R headset, NucleusTM bio-sensing hub, and associated software platforms, with a mission to empower millions of people affected by speech and mobility challenges. Learn more at cognixion.com.

For media inquiries, please contact [email protected]

SOURCE: Cognixion

View the original press release on ACCESS Newswire

A.Jones--AMWN