RecruitingNot ApplicableNCT06810219

Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Cognixion ALS BCI Longitudinal Study

Sponsor

Cognixion

Enrollment

10 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

ALS (Amyotrophic Lateral Sclerosis)

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brain-computer interface (BCI) communication device called the Cognixion Axon-R, which uses augmented reality and brain signals to help people with late-stage ALS (amyotrophic lateral sclerosis) communicate without speaking or moving their hands. The goal is to understand how quickly participants can learn to use the device and how well it works compared to eye-tracking alternatives. You may be eligible if you are 18 or older, have ALS and need an assistive communication device, can open and sustain your eyes voluntarily, speak English, and have a trusted person who can consent on your behalf and be trained on the system. Participation involves using the device over a 3-month period in the greater Los Angeles area with regular assessments of usability and communication quality. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.