Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Part of paid clinical trials in Santa Barbara, California.

Sponsor
Cognixion
Study ID
NCT06810219
Status
Recruiting
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Conditions

  • ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

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

Interventions

  • Cognixion ONE — DEVICE
    A wearable augmented reality brain computer interface with self contained computer and software to enable communication using the device input and output capabilities.

Study Details

The goal of this study is refine the usability of a BCI based communication platform. The study will take place in the greater Los Angeles area and will enroll up to 10 participants with late stage ALS. Each subject will receive a Cognixion Axon-R augmented reality brain computer interface and associated communication software. The study duration is 3 months for each participant. The key questions that will be addressed in this study are: 1. How quickly can participants learn and gain confidence with a pure BCI interface. 2. How effective are alternate input modalities including eye tracking for this use case. 3. Identify the extent to which generative AI based personalization impacts the communication quality. Key measures include: ITR - information transfer rate SUS - system usability scale

Key Dates

Start date
Jan 20, 2025
Status verified
Jan 2025
Primary completion
Aug 30, 2025
Completion
Oct 31, 2025

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 Axon-R device and associated communication software for practice and communication tasks as prescribed by the study administrator.

Primary Outcome Measure

System Usability Score [ Time Frame: 3 months from training and setup of device. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CognixionSanta BarbaraCalifornia93101-1665
Chris Ullrich
[email protected]
8053200774
Cole Study Coordinator
[email protected]
214-907-6399
Chris Principal Investigator (PRINCIPAL_INVESTIGATOR)

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