Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06810219

Cognixion ALS BCI Longitudinal Study Augmented Reality Brain Computer Interface for Late Stage ALS Communication

Led by Cognixion · Updated on 2025-02-05

10

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the usability of an augmented reality brain computer interface (BCI) communication platform for people with late stage ALS (Amyotrophic Lateral Sclerosis). The study aims to understand how quickly participants can learn and become confident with a pure BCI interface, how effective alternative inputs like eye tracking are, and how generative AI personalization affects communication quality. Up to 10 participants in the greater Los Angeles area will take part in this study. Each participant will receive a Cognixion Axon-R device, a wearable augmented reality BCI with built-in computer and software designed to support communication. Participants will use the device and its communication software for practice and communication tasks as directed by the study administrator. The study lasts 3 months for each participant, during which they will regularly use the device and software. Participants will be involved in training and using the device, with researchers measuring outcomes such as the System Usability Score and Information Transfer Rate after 3 months of use. Words per Minute will also be tracked as a secondary outcome. The study will monitor how well participants can communicate with the device and assess its ease of use. The total participation time is 3 months from training and setup of the device.

CONDITIONS

Brief Title

Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must have someone legally authorized to consent and present during the study
  • Must have a designated individual who can be trained on the Cognixion system
  • Fluent in understanding English
  • 18 years or older
  • Diagnosed with ALS and in need of an assistive communication device
  • Able to open and sustain eye opening independently
  • Have a reliable way to communicate "Yes" and "No" besides using the Cognixion device, such as vocalizations or head nods
Not Eligible

You will not qualify if you...

  • Disruption in English comprehension due to lack of fluency or language disorders
  • Severely hearing impaired or deaf
  • Sensitivity to flashing lights
  • History of epilepsy or seizures
  • Vision disorders limiting visual field, including glaucoma, diplopia, or nystagmus
  • History of vertigo or vestibular disorders
  • Scalp prone to irritation, inflammation, injury, or infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Implementation

Duration - 3 months from training and setup of device

Participants utilize the Cognixion ONE augmented reality brain computer interface device and associated communication software for practice and communication tasks as prescribed by the study administrator.

Regular visits during the 3 months as prescribed by the study administrator

Trial Site Locations

Total: 1 location

1

Cognixion

Santa Barbara, California, United States, 93101-1665

Actively Recruiting

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Research Team

C

Christopher Principal Investigator

C

Cole Study Coordinator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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Published Research Related To This Trial

Electrophysiological correlates of neurodegeneration in motor and non-motor brain regions in amyotrophic lateral sclerosis-implications for brain-computer interfacing.

Philipp Kellmeyer, Moritz Grosse-Wentrup, Andreas Schulze-Bonhage...

https://pubmed.ncbi.nlm.nih.gov/29676287