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Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Cognixion ALS BCI Longitudinal Study

Who can join

Ages 18 and older · All sexes

Inclusion criteria:

* Must have someone (LAR) who can consent to their participation and who will be present in the study alongside the participant
* Must have a designated individual who can be trained on the Cognixion system
* Fluent in understanding English
* 18 years or older
* Must have ALS and need an assistive communication device
* Must be able to engage in volitional eye opening and sustain eye opening independently for x duration
* Must have a way to communicate apart from using the Cognixion device such as vocalizations, head nod, eye blinks, eyebrow raises, etc. At a minimum, reliable way of communicating "Yes" and "No"

Exclusion criteria:

* Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)
* Severely hearing impaired or deaf
* Sensitivity to flashing lights
* History of epilepsy and/or seizures
* Vision disorders restricting the visual field such as glaucoma, diplopia (double vision), nystagmus (involuntary eye movements)
* History of vertigo or other vestibular disorders
* Scalp that is prone to irritation, inflammation, injury, or infectious process

About the study

The goal of this study is refine the usability of a BCI based communication platform.

The study will take place in the greater Los Angeles area and will enroll up to 10 participants with late stage ALS. Each subject will receive a Cognixion Axon-R augmented reality brain computer interface and associated communication software. The study duration is 3 months for each participant.

The key questions that will be addressed in this study are:

1. How quickly can participants learn and gain confidence with a pure BCI interface. 2. How effective are alternate input modalities including eye tracking for this use case. 3. Identify the extent to which generative AI based personalization impacts the communication quality.

Key measures include:

ITR - information transfer rate SUS - system usability scale

What is being tested

• Cognixion ONE (device)

Sponsor: Cognixion · Participants: 10 · Started: Jan 20, 2025

Contact the study team

• Christopher Principal Investigator · Phone: 8053200774
• Cole Study Coordinator · Phone: 214-907-6399

Official record on ClinicalTrials.gov — NCT06810219

Locations in the U.S.

Conditions

• Amyotrophic Lateral Sclerosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.