Study of Cognixion ONE Augmented Reality Brain-Computer Interface for Communication in Adults with Late Stage ALS
Led by Cognixion · Updated on 2025-02-05
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
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
Research Team
C
Christopher Principal Investigator
C
Cole Study Coordinator
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Cognixion ONE (AR‑BCI device)
Eye‑gaze speech‑generating device (current care)
What it is
A wearable augmented‑reality brain‑computer interface (Cognixion ONE) enabling communication via device input and output.
An established eye‑gaze‑driven speech‑generating device that supports communication for people with ALS.
Role in study
Participants use this device during the usability feasibility evaluation.
Serves as the commonly used assistive communication method outside the trial.
Primary use
To assess usability and feasibility of AR‑BCI to enable communication via device interface.
To provide communication access using eye‑gaze control for selecting messages or letters.
How it is used
Participant wears the AR headset with integrated computer and software controlling communication via brain‑computer interface.
User controls speech output by moving eyes to select letters or messages on a speech‑generating device.
Evidence maturity
Feasibility being evaluated; evidence is preliminary and limited to usability data.
Eye‑gaze SGDs have established clinical use and documented effectiveness in ALS communication.
Important risks
Not reported in registry; safety risks are not specified.
Safety considerations not detailed; typical device risks not specified in sources.
Important limitations
Results limited to feasibility/usability in small sample; broader effectiveness and long‑term use not established.
Eye‑gaze SGDs require calibration, eye control, and may be slower or limited in severe oculomotor impairment.
Potential patient impact
Impact on communication ability patient‑observed outcomes not yet available.
Use of eye‑gaze SGDs supports maintained communication when speech fails.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
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
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
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
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...