Status:
NOT_YET_RECRUITING
Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro
Lead Sponsor:
Cognixion
Conditions:
ALS (Amyotrophic Lateral Sclerosis)
TBI Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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"
- 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
- Claustrophobia related to the Apple Vision Pro with comfort adapter
- 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
Exclusion
Key Trial Info
Start Date :
October 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07209943
Start Date
October 16 2025
End Date
May 31 2026
Last Update
October 7 2025
Active Locations (1)
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1
Cognixion HQ
Santa Barbara, California, United States, 93101-1665