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NCT Number: NCT07209943

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

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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Key information

Conditions

ALS (Amyotrophic Lateral Sclerosis) Amyotrophic Lateral Sclerosis Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies SCI - Spinal Cord Injury Spinal Cord Diseases Spinal Cord Injuries Stroke TBI Traumatic Brain Injury TDP-43 Proteinopathies Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognixion + Apple Vision Pro

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.

Primary outcomes

  1. System Usabilty Score

    Time frame: 3-4 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.

  2. Information Transfer Rate (ITR)

    Time frame: 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.

Secondary outcomes

  1. Phrases per Minute

    Time frame: 3-4 months from training

    PPM is the number of complete phrases or compute rcommands that the user can construct in 1 minute. This is a usage metric that captures the efficiency of the device in predicting user utterances and does not relate to any health outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Ullrich, M.Sc.

CONTACT

[email protected]

18053200774

Cole Heiner, B.Sc.

CONTACT

[email protected]

214-907-6399

Sponsors and collaborators

Lead sponsor

Cognixion

Industry

Registry information

Official study title

Cognixion Pass Through Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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