Cognixion
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.
Within-subject longitudinal evaluation. Each participant serves as their own control and uses all three modalities across a 12-week primary endpoint window: (a) their existing commercial eye-gaze speech generating device as the active comparator, (b) the Cognixion ONE AR-BCI configuration, and (c) the Cognixion ONE screen-based BCI configuration. Letterboard is retained as a within-subject fallback for participants whose eye-gaze becomes non-viable during the window. The Cognixion ONE platform combines a constant medical-grade EEG sensing assembly (Axon-R, IEC 60601 certified) with one of thr…
Inclusion Criteria: * Diagnosis of ALS established by a neurologist, meeting either the Gold Coast Criteria (preferred) or the revised El Escorial criteria (definite, probable, probable laboratory-supported, or possible ALS), documented by the referring or treating neurologist * ALSFRS-R Speech subscale score of 3 or lower (impaired but functional speech) through 0 (anarthric) * Documented use of a Tobii Dynavox or Smartbox eye-gaze speech generating device as primary or secondary communication method for at least 30 days prior to screening. Candidates who meet all other criteria but lack a p…
Non-invasive EEG-based brain-computer interface using steady-state visual evoked potentials, presented on a head-worn augmented-reality display, with AI-assisted word and phrase suggestion. Input modalities available: pure BCI, hybrid eye-tracking plus BCI, eye tracking, and switch control, subject to display configuration.
The same EEG sensing assembly and communication application presented on an external screen rather than a head-worn display.
The participant's own prescribed commercial eye-gaze speech generating device, used as the active within-subject comparator.