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Augmented Reality BCI for ALS, Stroke, TBI, and SCI

This study is testing a new communication system called Cognixion + Apple Vision Pro. This system uses augmented reality (like a digital overlay on the real world) and a brain-computer interface (BCI), which allows you to control a computer with your thoughts, eye movements, and head position. The goal is to see how well people with conditions like ALS (Amyotrophic Lateral Sclerosis), TBI (Traumatic Brain Injury), SCI (Spinal Cord Injury), or Stroke can use this device to communicate and control a computer. We want to make sure it's easy to use and effective. The study will involve up to 10 participants in the United States and will last for 3-4 months for each person.

Study design
This is an interventional study, meaning participants will receive a specific device. It aims to enroll up to 10 participants.
What's involved
You would use the integrated Cognixion + Apple Vision Pro device for 3-4 months. You must also have a support person who can be trained on the system.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, System Usability Score and Information Transfer Rate, will be measured at 3-4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07209943

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

Not Yet Recruiting
NAAges 18+InterventionalDevice feasibility
Cognixion
~10 participants
Updated 2025-10-07 on ClinicalTrials.gov
What's tested:Cognixion + Apple Vision Pro

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
System Usabilty Score
Measured over 3-4 months
+1 more outcome measured

Conditions

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

Explore related trials

Amyotrophic Lateral SclerosisSpinal Cord InjuryStrokeTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Christopher J Ullrich · PRINCIPAL_INVESTIGATOR · Cognixion

Who to contact

Christopher Ullrich, M.Sc.
[email protected]
18053200774
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • System Usabilty Score3-4 months

    A score ranging from 0 to 100 that captures the usability the device and enables it to be compared with other human machine interface devices. This is an intrisic property of the device interface (hardware/software) and is not a healh outcome measure.

  • Information Transfer Rate (ITR)3-4 months

    The rate, in bits per minute, of information transfer for each of the device modalities. ITR is measured using a standardized selection procedure and is a measure the captures how efficient the device interface is. It is an essential measure of device throughput and is not related to any health outcome.