NCT07209943Not yet recruiting
Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro
Cognixion Pass Through Study
Source: ClinicalTrials.gov · Last updated 7 Oct 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 capable communication platform. The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord injury (SCI) that have assistive communication and computer control needs. Each subject will receive an integrated Cognixion + Apple Vision Pro device that includes an augmented reality brain computer interface and associated communication software. The study duration is 3-4 months for each participant. The key questions that will be addressed in this study are: 1. Identify the ability of individuals with target indications to use the integrated Cognixion-Apple Vision Pro system to communicate effectively. 2. Identify the ability of such individuals to learn to use BCI, ET-BCI and other modalities, and to measure their progress over time. 3. Identify the effectiveness of the different forms of input supported by the combined Cognixion-Apple Vision Pro system (BCI, eye-tracking) in allowing such individuals to communicate and have agency. 4. Identify how input such as BCI can be optimized to suit the needs of individuals (e.g., specific frequencies that work best for an individual, SNR with different frequencies, number of targets, length of recording for each frequency) and improve overall usability. 5. Identify the extent to which personalization through a large language model (LLM) affects communication. 6. Identify the appropriate capabilities to enable through an agentic communication interface. Key measures include: ITR - information transfer rate SUS - system usability scale
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- 16 Oct 2025
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Cognixion
- Diseases
- ALS (motor neurone disease), Stroke
- NCT number
- NCT07209943
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 16 Oct 2025 to the primary completion date, 30 Apr 2026
- 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
- Claustrophobia related to the Apple Vision Pro with comfort adapter
- Scalp that is prone to irritation, inflammation, injury, or infectious process
Who the study is looking for
- Must have a designated on-site support individual who can be trained on the Cognixion system
- Fluent in understanding English
- 18 years or older
- Must have one of ALS, spinal cord injury or chronic brain injury and need an assistive communication device
- Must be able to engage in volitional eye opening and sustain eye opening independently for at least 30 minutes.
- 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, independent 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 HQ Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.