Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

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

NCT Number	NCT06810219
Lead Sponsor	Cognixion
Conditions	ALS (Amyotrophic Lateral Sclerosis)
Enrollment	10 participants
Start Date	2025-01-20
Primary Completion	2025-08-30 (estimated)
Study Completion	2025-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-05