RECRUITINGINTERVENTIONAL

Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Cognixion ALS BCI Longitudinal Study

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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" Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Cognixion ONE

A wearable augmented reality brain computer interface with self contained computer and software to enable communication using the device input and output capabilities.

Locations (1)

Cognixion

Santa Barbara, California, United States