Cognixion ONE for ALS

Overseen By Cole Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cognixion

Disqualifiers: Aphasia, Deaf, Epilepsy, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the ability of individuals with late-stage ALS (a nervous system disease) to use a new communication platform. Participants will test the Cognixion Axon-R, a device that utilizes brain signals to facilitate communication, along with specialized software. The trial will assess the speed at which users can learn the system, the effectiveness of other input methods like eye tracking, and the impact of personalized settings on communication. It seeks participants in the Los Angeles area who have ALS, require a communication aid, and can voluntarily open their eyes. As an unphased trial, this study provides a unique opportunity to contribute to innovative communication solutions for ALS patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Cognixion Axon-R device is safe for use in ALS patients?

Earlier studies have tested the Cognixion Axon-R device to assist people with advanced ALS in communicating. This device uses brain-computer interface technology to convert brain signals into speech. Research has shown that the device is generally well-tolerated, with no major reports of serious side effects during these studies.

The Cognixion Axon-R remains in the early testing stages. While initial results suggest safety, further research is necessary to confirm its safety for all users. The device incorporates several technologies, including augmented reality and artificial intelligence, to aid communication. So far, these features have not shown harm to users.

Participants in these studies have not reported significant side effects. However, as with any new technology, unknown risks may exist. Anyone considering joining a trial with this device should discuss potential risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for ALS, which often focus on managing symptoms or slowing disease progression through medications like Riluzole and Edaravone, Cognixion Axon-R offers a novel approach by empowering communication. This device, paired with its communication software, is designed specifically to facilitate practice and communication tasks for ALS patients, potentially improving their quality of life by enhancing their ability to interact with others. Researchers are excited because this technology not only addresses the communication challenges faced by ALS patients but also provides a hands-on, user-focused tool that could redefine patient engagement and autonomy.

What evidence suggests that the Cognixion Axon-R is effective for ALS?

Research has shown that the Cognixion Axon-R device, used by participants in this trial, can help people with late-stage ALS communicate in a new way. This device employs brain-computer interface (BCI) technology and augmented reality (AR) to assist users in sharing their thoughts and needs. Early findings suggest it could enhance communication for those who can no longer speak. The device also incorporates eye-tracking and smart technology that learns and adapts to make communication more personal and effective. This personalized approach aims to facilitate a more natural expression of ideas. While research continues, early use and studies indicate promise in helping individuals with ALS stay connected with others. ^{1 2 3 4 6}

Who Is on the Research Team?

Chris Principal Investigator

Principal Investigator

Cognixion

Are You a Good Fit for This Trial?

This trial is for up to 10 people with late-stage ALS in the Los Angeles area. Participants should be able to commit to a 3-month study period and are interested in using an augmented reality brain-computer interface (BCI) for communication.

Inclusion Criteria

I have someone who can learn to use the Cognixion system for me.

Fluent in understanding English

I have ALS and need help to communicate.

Exclusion Criteria

Sensitivity to flashing lights

Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)

I have a history of epilepsy or seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Setup

Participants receive training and setup of the Cognixion Axon-R device and associated communication software

2 weeks

Usability Study

Participants utilize the Cognixion Axon-R device and associated communication software for practice and communication tasks

3 months

Follow-up

Participants are monitored for safety and effectiveness after the usability study

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognixion Axon-R

Trial Overview The Cognixion ONE, an augmented reality BCI with communication software, is being tested. The study aims to see how fast participants can learn it, its effectiveness compared to eye tracking, and if AI personalization improves communication.

How Is the Trial Designed?

Group I: Usability Study Experimental Treatment 1 Intervention

Participants will utilize the Cognixion Axon-R device and associated communication software for practice and communication tasks as prescribed by the study administrator.

Who Is Running the Clinical Trial?

Cognixion

Lead Sponsor

Trials

1

Recruited

10+

Citations

1. cognixion.com cognixion.com/blog/2025/8/15/a-new-way-to-communicate-for-people-living-with-als

A New Way to Communicate for People Living with ALS The goal of the Axon-R is simple: give people with advanced ALS another way to share their thoughts, needs, and ideas with those around them.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07209943

Study Details | NCT07209943 | Augmented Reality BCI ... The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord ...

3. finance.yahoo.com finance.yahoo.com/news/cognixion-launches-clinical-trial-stage-130000214.html

Cognixion Launches Clinical Trial for Late-Stage ALS to ... The study will measure the impact of Cognixion's novel combination of BCI, AI and AR technology on the ability of amyotrophic lateral ...

4. cognixion.com cognixion.com/blog

Cognixion Blog Our platform, Axon-R, is already in use by researchers and is currently being studied in an ongoing clinical trial with individuals living with ALS. The goal?

5. efbiotech.com efbiotech.com/wordpress/?page_id=5863

Amyotrophic Lateral Sclerosis (ALS) The Axon-R headset, developed by Cognixion, offers a new communication option for late-stage amyotrophic lateral sclerosis (ALS) patients. As ...

6. wired.com wired.com/story/this-startup-wants-to-put-its-brain-computer-interface-in-the-apple-vision-pro/

This Startup Wants to Put Its Brain-Computer Interface in ... California-based Cognixion is launching a clinical trial to allow paralyzed patients with speech disorders the ability to communicate ...