CClinicalTrials.gg
Sign In
RecruitingNCT06810219Updated Feb 5, 2025

Augmented Reality BCI Longitudinal Study for Persons with Late Stage ALS

An interventional study of Cognixion ONE in ALS (Amyotrophic Lateral Sclerosis), sponsored by Cognixion. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Cognixion · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • ALS (Amyotrophic Lateral Sclerosis)

Keywords

  • usability study
  • augmented reality
  • brain computer interface
  • Amyotrophic lateral sclerosis
  • als
  • generative AI
  • longitudinal study
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's planned enrollment of 10 is below the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Cognixion is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Must have someone (LAR) who can consent to their participation and who will be present in the study alongside the participant
  • Must have a designated individual who can be trained on the Cognixion system
  • Fluent in understanding English
  • 18 years or older
  • Must have ALS and need an assistive communication device
  • Must be able to engage in volitional eye opening and sustain eye opening independently for x duration
  • 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 way of communicating "Yes" and "No"

Exclusion criteria

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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study 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.

    Device: Cognixion ONE

Interventions

  • DeviceCognixion ONE

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

06

What researchers measure

Primary outcomes

  1. System Usability Score

    A score ranging from 0 to 100 that captures the usability the device. This is an essential characteristic of a device feasibility study.

    Time frame: 3 months from training and setup of device.

  2. 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.

    Time frame: 3 months from training and setup of device.

Secondary outcomes

  1. Words per Minute (WPM)

    WPM is the number of words that a participant can speak in one minute. This statistic is calculated by counting the total time from partner utterance until a response is spoken by the participant.

    Time frame: 3 months from training and setup of device.

07

Study locations

1 of 1 sites recruiting
  • Cognixion
    Santa Barbara, California 93101-1665, United States
    Recruiting
08

References and documents

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. PubMed 29676287 ↗
  • 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. PubMed 29950436 ↗

Individual participant data

Plan to share: Yes — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06810219
Lead sponsor
Cognixion
Responsible party
Sponsor
First posted
Feb 5, 2025
Start date
Jan 20, 2025
Primary completion
Aug 30, 2025 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Feb 5, 2025

Study contacts

Christopher Principal Investigator
Contact
chris@cognixion.com
8053200774
Cole Study Coordinator
Contact
cole@cognixion.com
214-907-6399
Chris Principal Investigator
principal investigator · Cognixion

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Motor Neuron Disease→

Other studies from this sponsor

Cognixion

Start the discussion