NCT06810219Recruiting
Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS
Cognixion ALS BCI Longitudinal Study
Source: ClinicalTrials.gov · Last updated 5 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 22 Jan 2025
- Start date
- 20 Jan 2025
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- Cognixion
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06810219
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 20 Jan 2025 to the primary completion date, 30 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)
- 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
Other
- Severely hearing impaired or deaf
- Sensitivity to flashing lights
- Scalp that is prone to irritation, inflammation, injury, or infectious process
Who the study is looking for
- 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"
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cognixion Coordinator of this site? Confirm its status | Santa Barbara | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.