Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro

Cognixion

Status: Not yet enrolling

Conditions: Stroke; SCI - Spinal Cord Injury; ALS (Amyotrophic Lateral Sclerosis); TBI Traumatic Brain Injury

Treatments: Device: Cognixion + Apple Vision Pro

Study type: Interventional

Funder types: Industry

Identifiers

NCT07209943

COG-AVP-002

Details and patient eligibility

About

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

The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord injury (SCI) that have assistive communication and computer control needs. Each subject will receive an integrated Cognixion + Apple Vision Pro device that includes an augmented reality brain computer interface and associated communication software. The study duration is 3-4 months for each participant.

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

1. Identify the ability of individuals with target indications to use the integrated Cognixion-Apple Vision Pro system to communicate effectively.
2. Identify the ability of such individuals to learn to use BCI, ET-BCI and other modalities, and to measure their progress over time.
3. Identify the effectiveness of the different forms of input supported by the combined Cognixion-Apple Vision Pro system (BCI, eye-tracking) in allowing such individuals to communicate and have agency.
4. Identify how input such as BCI can be optimized to suit the needs of individuals (e.g., specific frequencies that work best for an individual, SNR with different frequencies, number of targets, length of recording for each frequency) and improve overall usability.
5. Identify the extent to which personalization through a large language model (LLM) affects communication.
6. Identify the appropriate capabilities to enable through an agentic communication interface.

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 a designated on-site support individual who can be trained on the Cognixion system
• Fluent in understanding English
• 18 years or older
• Must have one of ALS, spinal cord injury or chronic brain injury and need an assistive communication device
• Must be able to engage in volitional eye opening and sustain eye opening independently for at least 30 minutes.
• 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, independent 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
• Claustrophobia related to the Apple Vision Pro with comfort adapter
• 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 + 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.

Treatment:

Device: Cognixion + Apple Vision Pro