Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Recruiting now · Not applicable

Conditions studied: ALS (Amyotrophic Lateral Sclerosis)

In brief

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

Key facts

Study ID: NCT06810219
Run by: Cognixion
People needed: 10
Starts: 2025-01-20
Expected to finish: 2025-10-31
Last updated by the study team: 2025-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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"

You may not qualify if…

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

Where it is running

Cognixion — Santa Barbara, California, United States (enrolling)

Full record on ClinicalTrials.gov

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