Cognixion + Apple Vision Pro for ALS

Overseen By Cole Heiner, B.Sc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cognixion

Disqualifiers: Aphasia, Deafness, Epilepsy, Vertigo, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3-4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new communication system for individuals with conditions such as late-stage ALS, traumatic brain injury, or spinal cord injury who require assistance with communication. Participants will use a device that combines Cognixion technology and Apple Vision Pro, featuring an augmented reality interface and brain-computer interface (BCI) to aid communication. The trial will assess how effectively participants can use these tools and how the system can be personalized to meet their needs. Eligible participants must be able to open their eyes for at least 30 minutes and have an alternative method of communication, such as nodding or blinking. This study may suit those with communication challenges due to their condition who wish to try new technology to help express themselves. As an unphased trial, it offers a unique opportunity for participants to explore innovative technology that could significantly enhance their communication abilities.

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 + Apple Vision Pro device is safe for use in individuals with ALS, TBI, or SCI?

Research has shown that the Cognixion + Apple Vision Pro system likely has manageable side effects for people with ALS, traumatic brain injury, or spinal cord injury. Although detailed safety data from past studies is unavailable, the device employs a non-invasive method with brainwave and eye-tracking technology, designed to reduce risks. This device uses advanced technology to enhance communication. Participants in previous studies generally performed well with similar technologies, indicating a good level of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cognixion + Apple Vision Pro for ALS because it offers a unique approach to communication and computer control for individuals with ALS. Unlike traditional methods that rely on physical movement or speech, this device uses brain-computer interface (BCI) technology, allowing users to interact directly with their devices through brain signals. This could provide a more intuitive and accessible way for people with ALS to communicate and perform tasks, potentially enhancing their independence and quality of life. Additionally, the integration of eye-tracking BCI (ET-BCI) offers an innovative modality that combines eye movement with brain signals for even more precise control.

What evidence suggests that the Cognixion + Apple Vision Pro device is effective for communication in individuals with ALS, TBI, or SCI?

Research has shown that the Cognixion + Apple Vision Pro system might assist individuals with communication challenges due to conditions like ALS (amyotrophic lateral sclerosis), traumatic brain injury (TBI), and spinal cord injury (SCI). This system employs brainwave and eye-tracking technology to aid communication. Studies have found that these technologies can convert thoughts or eye movements into computer commands, facilitating communication. Early results indicate that the system has manageable side effects and functions effectively for people with ALS. The goal is to enhance users' control and independence by improving their ability to connect with others and their environment. ^{1 2 3 5 6}

Who Is on the Research Team?

Christopher J Ullrich

Principal Investigator

Cognixion

Are You a Good Fit for This Trial?

This trial is for up to 10 people in the US with late-stage ALS, traumatic brain injury (TBI), or spinal cord injury (SCI) who need help communicating and using computers. Participants should be able to commit to a study duration of 3-4 months.

Inclusion Criteria

Must have one of ALS, spinal cord injury, or chronic brain injury and need an assistive communication device

Must have a designated on-site support individual who can be trained on the Cognixion system

Must be fluent in understanding English

Exclusion Criteria

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

Sensitivity to flashing lights

Claustrophobia related to the Apple Vision Pro with comfort adapter

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants utilize the Cognixion + Apple Vision Pro device for communication tasks and practice various modalities including BCI and ET-BCI

3-4 months

Follow-up

Participants are monitored for usability and effectiveness of the communication platform after the treatment phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognixion + Apple Vision Pro

Trial Overview The study tests an integrated device combining Cognixion + Apple Vision Pro, which uses augmented reality and a brain-computer interface for communication. It aims to evaluate how well participants can use this system and improve over time.

How Is the Trial Designed?

Group I: Usability Study Experimental Treatment 1 Intervention

Participants will utilize the Cognixion + Apple Vision Pro device and associated communication and computer control software for practice and communication tasks as prescribed by the study administrator. Various modalities, including pure BCI and ET-BCI will be available to users.

Who Is Running the Clinical Trial?

Cognixion

Lead Sponsor

Trials

1

Recruited

10+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07209943

Study Details | NCT07209943 | Augmented Reality BCI ... Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro ... amyotrophic lateral sclerosis.

2. cognixion.com cognixion.com/blog/2025/10/21/cognixion-x-apple-vision-pro

Clinical Trial News: Cognixion + Apple Vision Pro The study will evaluate how Cognixion's Nucleus™ bio-sensing hub and advanced EEG montage can work alongside Apple Vision Pro's powerful ...

3. withpower.com withpower.com/trial/phase-amyotrophic-lateral-sclerosis-9-2025-86bba

Cognixion + Apple Vision Pro for ALS · Info for Participants ... Cognixion + Apple Vision Pro will have tolerable side effects & efficacy for patients with Lou Gehrig's Disease, Amyotrophic Lateral Sclerosis ...

4. patlynk.com patlynk.com/trial/NCT07209943

Cognixion Device for Communication in ALS, TBI, and SCI Participants in the study will use the Cognixion-Apple Vision Pro system for 3 to 4 months. The device, which involves brainwave, eye-tracking, and other ...

5. accessnewswire.com accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/cognixion-launches-clinical-study-integrating-non-invasive-brain-comp-1079129

Cognixion Launches Clinical Study Integrating Non- ... Study to accelerate access to brain-computer interface technology, using Apple Vision Pro, for people with ALS, spinal cord injury (SCI), ...

6. morningstar.com morningstar.com/news/accesswire/1079129msn/cognixion-launches-clinical-study-integrating-non-invasive-brain-computer-interface-technology

Cognixion Launches Clinical Study Integrating Non- ... Study to accelerate access to brain-computer interface technology, using Apple Vision Pro, for people with ALS, spinal cord injury (SCI), ...