Brain-Computer Interface Communication Device for People With ALS

This study compares a wearable brain-computer interface (BCI) communication device with the eye-tracking communication devices that people with ALS already use. As ALS progresses, speech is lost and many people come to rely on an eye-tracking speech generating device. Eye-tracking performance can decline as oculomotor control is affected, and some people reach a point where it no longer works reliably for them. The Cognixion ONE device adds a brain-computer interface input, which does not depend on eye movement, alongside an AI-assisted communication application. Thirty adults with ALS who currently use a Tobii Dynavox or Smartbox eye-tracking device will take part. Each participant uses three communication options at home over a 12-week period: their own eye-tracking device, the Cognixion ONE device with a head-worn augmented-reality display, and the Cognixion ONE device with a screen-based display. For some sessions the option is assigned; for others the participant chooses. The main measure is how much time participants voluntarily choose to spend using each option. That choice is treated as the clearest signal of which option genuinely works better for them. The study also measures communication speed and accuracy, usability, workload, quality of life, and caregiver burden. The Cognixion ONE device is an investigational research device. It is not approved or cleared by the U.S. Food and Drug Administration for any medical use.