ALS (Amyotrophic Lateral Sclerosis)
Conditions
Keywords
usability study, augmented reality, brain computer interface, Amyotrophic lateral sclerosis, als, generative AI, longitudinal study
Brief 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
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.
Sponsors
Cognixion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Score | 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Words per Minute (WPM) | 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. |
Countries
United States
Contacts
Primary ContactChristopher Principal Investigator
Backup ContactCole Study Coordinator
Outcome results
None listed