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

Starting soon · Not applicable

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

In brief

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

Key facts

Study ID: NCT07209943
Run by: Cognixion
People needed: 10
Starts: 2025-10-16
Expected to finish: 2026-05-31
Last updated by the study team: 2025-10-07

Who can join

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

You may qualify if…

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"

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
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

Where it is running

Cognixion HQ — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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