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

Part of paid clinical trials in Santa Barbara, California.

Sponsor
Cognixion
Study ID
NCT07209943
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

Start date
Oct 16, 2025
Status verified
Sep 2025
Primary completion
Apr 30, 2026
Completion
May 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • 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.

Primary Outcome Measure

System Usabilty Score [ Time Frame: 3-4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cognixion HQSanta BarbaraCalifornia93101-1665
Chris Ullrich, M.Sc.
[email protected]
805-320-0774
Cole Heiner, M.A.
[email protected]
214-907-6399
Christopher J Ullrich, M.Sc. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Santa Barbara, CA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Cognixion HQ· Santa Barbara, CA

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