Augmented Reality BCI Longitudinal Study for Persons with Late Stage ALS

Cognixion

Status: Enrolling

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Treatments: Device: Cognixion ONE

Study type: Interventional

Funder types: Industry

Identifiers

NCT06810219

ALSUS1

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Usability Study

Experimental group

Description:

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

Treatment:

Device: Cognixion ONE