NCT06810219

Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Cognixion ALS BCI Longitudinal Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cognixion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• ALS (Amyotrophic Lateral Sclerosis)

Interventions

Type	Name	Description
DEVICE	Cognixion ONE	A wearable augmented reality brain computer interface with self contained computer and software to enable communication using the device input and output capabilities.

Timeline

• Start date: 2025-01-20
• Primary completion: 2025-08-30
• Completion: 2025-10-31
• First posted: 2025-02-05
• Last updated: 2025-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study