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Augmented Reality BCI Study for Late Stage ALS

This study is testing a wearable device called Cognixion ONE, which is an augmented reality brain-computer interface (BCI). It's designed to help people with late-stage Amyotrophic Lateral Sclerosis (ALS) communicate. Researchers want to see how easy it is for participants to learn and use this device, how well other ways of inputting information (like eye tracking) work, and if personalized settings using artificial intelligence (AI) improve communication. The study aims to enroll up to 10 participants in the greater Los Angeles area. To join, you must be at least 18 years old, have late-stage ALS and need a communication device, be able to open your eyes voluntarily, and have someone who can help you with the study and learn to use the device. The main goals are to measure how usable the system is and how quickly information can be transferred using it, both after three months.

Study design
This is an interventional study, meaning participants will receive a specific device. It plans to enroll up to 10 participants with late-stage ALS.
What's involved
Each participant will use the Cognixion Axon-R device and associated software for a duration of 3 months. Someone must be present with the participant and trained on the system.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for the study are taken at 3 months from the start of device training and setup.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06810219

Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Recruiting
NAAges 18+InterventionalDevice feasibility
Cognixion
~10 participants
Updated 2025-02-05 on ClinicalTrials.gov
What's tested:Cognixion ONE

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
System Usability Score
Measured over 3 months from training and setup of device.
+1 more outcome measured

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Explore related trials

Amyotrophic Lateral Sclerosis

NCT06810219

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cognixion

    Santa Barbara, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Chris Principal Investigator · PRINCIPAL_INVESTIGATOR · Cognixion

Who to contact

Christopher Principal Investigator
[email protected]
8053200774
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • System Usability Score3 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.

  • Information Transfer Rate (ITR)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.