Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06810219

Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Led by Cognixion · Updated on 2025-02-05

10

Participants Needed

1

Research Sites

40 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official 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 a legally authorized representative who can consent and be present during the study
  • Must have a designated person who can be trained to use the Cognixion system
  • Fluent in understanding English
  • 18 years or older
  • Diagnosed with ALS and require an assistive communication device
  • Able to open and maintain eye opening voluntarily for a certain duration
  • Have a reliable way to communicate "Yes" and "No" outside of using the Cognixion device, such as vocalizations, head nods, eye blinks, or eyebrow raises
Not Eligible

You will not qualify if you...

  • Difficulty understanding English due to lack of fluency or language disorders such as aphasia
  • Severe hearing loss or deafness
  • Sensitivity to flashing lights
  • History of epilepsy or seizures
  • Vision problems limiting the visual field, including glaucoma, double vision, or involuntary eye movements
  • History of vertigo or other balance disorders
  • Scalp conditions 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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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

CONTACT

C

Cole Study Coordinator

CONTACT

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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Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS | DecenTrialz