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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-16

Study Completion Date

2026-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Usability Study

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.

Group Type EXPERIMENTAL

Cognixion + Apple Vision Pro

Intervention Type DEVICE

An Apple Vision Pro device, integrated with Cognixion's brain sensing band and Assisted Reality software. The integrated device enables users to construct AI assisted communication and computer control commands using a combination of attention, eye gaze and head pose.

Interventions

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Cognixion + Apple Vision Pro

An Apple Vision Pro device, integrated with Cognixion's brain sensing band and Assisted Reality software. The integrated device enables users to construct AI assisted communication and computer control commands using a combination of attention, eye gaze and head pose.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No