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

Cognixion Pass Through Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; ALS (Amyotrophic Lateral Sclerosis); SCI - Spinal Cord Injury; TBI Traumatic Brain Injury
• Intervention / Treatment: Device: Cognixion + Apple Vision Pro

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Ullrich, M.Sc.; Phone Number: 18053200774; Email: chris@cognixion.com
• Study Contact Backup: Name: Cole Heiner, B.Sc.; Phone Number: 214-907-6399; Email: cole@cognixion.com

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93101-1665
      • Cognixion HQ
      • Contact: Chris Ullrich, M.Sc.; Phone Number: 805-320-0774; Email: chris@cognixion.com
      • Contact: Cole Heiner, M.A.; Phone Number: 214-907-6399; Email: cole@cognixion.com
      • Principal Investigator: Christopher J Ullrich, M.Sc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usabilty Score	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.	3-4 months
Information Transfer Rate (ITR)	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.	3-4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phrases per Minute	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.	3-4 months from training

Collaborators and Investigators

• Sponsor: Cognixion
• Investigators: Principal Investigator: Christopher J Ullrich, Cognixion

Publications and helpful links

General Publications

• Lewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590
• Kellmeyer P, Grosse-Wentrup M, Schulze-Bonhage A, Ziemann U, Ball T. Electrophysiological correlates of neurodegeneration in motor and non-motor brain regions in amyotrophic lateral sclerosis-implications for brain-computer interfacing. J Neural Eng. 2018 Aug;15(4):041003. doi: 10.1088/1741-2552/aabfa5. Epub 2018 Apr 20.
• Wolpaw JR, Bedlack RS, Reda DJ, Ringer RJ, Banks PG, Vaughan TM, Heckman SM, McCane LM, Carmack CS, Winden S, McFarland DJ, Sellers EW, Shi H, Paine T, Higgins DS, Lo AC, Patwa HS, Hill KJ, Huang GD, Ruff RL. Independent home use of a brain-computer interface by people with amyotrophic lateral sclerosis. Neurology. 2018 Jul 17;91(3):e258-e267. doi: 10.1212/WNL.0000000000005812. Epub 2018 Jun 27.

Study record dates

Study Major Dates

• Study Start (Estimated): October 16, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: September 18, 2025
• First Submitted That Met QC Criteria: September 29, 2025
• First Posted (Estimated): October 7, 2025

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: augmented reality; traumatic brain injury; spinal cord injury; brain computer interface; als; usability study; generative AI; agentic
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Brain Injuries; Nutritional and Metabolic Diseases; Brain Injuries, Traumatic; Stroke; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries
• Other Study ID Numbers: COG-AVP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Usability insights related to this use case on this type of device will be shared with other accessibility and BCI researchers at conference events and through publications. This data will be anonymized prior to sharing.
• IPD Sharing Time Frame: Clinical study report will be shared upon request once complete. Estimated to occur no sooner than April 1 2026.
• IPD Sharing Access Criteria: Anonymized clinical study report will be made available to clinical researchers, upon request and validation.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No