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NCT Number: NCT06810219

Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

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

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Key information

Conditions

ALS (Amyotrophic Lateral Sclerosis) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. System Usability Score

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

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

  2. Information Transfer Rate (ITR)

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

    The rate, in bits per minute, of information transfer for each of the device modalities.

    ITR is measured using a standardized selection procedure.

Secondary outcomes

  1. Words per Minute (WPM)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Principal Investigator

CONTACT

[email protected]

8053200774

Cole Study Coordinator

CONTACT

[email protected]

214-907-6399

Sponsors and collaborators

Lead sponsor

Cognixion

Industry

Registry information

Official study title

Cognixion ALS BCI Longitudinal Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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