Overview
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.
Description
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 three interchangeable display configurations - an Apple Vision Pro augmented-reality headset, XReal augmented-reality glasses, or an external screen - and a Cognixion-developed AI-assisted communication application. Selection is made by steady-state visual evoked potential response, optionally combined with eye tracking as a hybrid modality. Display configuration is selected per participant and may be changed during the study under documented criteria with participant re-consent.
All study activity is conducted by Cognixion personnel in participants' homes, with weekly remote supervision and at-least-monthly on-site visits. Recruitment partners provide referrals only and do not execute study activities. Sessions run 3 to 5 times per week at approximately one hour each, with a trained caregiver present for all sessions using the study device.
Enrollment is rolling across the first 18 months of a 36-month period of performance. Disease progression is tracked by the complete 12-item ALSFRS-R at baseline and every 4 weeks, entering the primary statistical model as a time-varying covariate.
The study is funded by the National Institute on Deafness and Other Communication Disorders under SBIR award R44DC023888, and builds on a completed Phase 1 feasibility study (NCT07209943).
Eligibility
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 prescribed eye-gaze device may be provided a loaner device, capped at 25 percent of the enrolled cohort
- Age 18 years or older
- A designated, trainable caregiver able to be present for structured study sessions and to complete a 2-hour onboarding and a Month-3 refresher
- Volitional eye opening sustained independently for at least 30 minutes, and sufficient visual function to perceive the augmented-reality display stimuli
- A reliable communication method other than the study device for affirmative assent, at minimum a yes/no channel via residual vocalization, head movement, blink, or brow raise
- Sufficient English comprehension to engage with the study protocol and the AI conversational interface
Exclusion Criteria:
- Active hospice enrollment without documented capacity to participate in research activities
- Cognitive or behavioral impairment of a degree that would preclude successful participation in study procedures, as judged by the treating neurologist, a study neurologist, or the study speech-language pathologist
- History of photosensitive epilepsy or active seizure disorder
- Sensitivity to flashing lights
- Severe uncorrected visual impairment that precludes use of an augmented-reality display
- Vision disorders restricting the visual field, such as glaucoma with significant field loss, diplopia, or nystagmus
- History of vertigo or other vestibular disorders that would be aggravated by augmented-reality display use
- Claustrophobia related to head-mounted display use, after attempted accommodation
- Scalp condition prone to irritation, inflammation, injury, or infectious process that precludes safe placement of EEG electrodes
- Severe oculomotor impairment that precludes establishment of an initial eye-gaze calibration on the participant's existing eye-gaze device
- Concurrent enrollment in another investigational communication-device or brain-computer interface trial
- Severe hearing impairment or deafness that would prevent participation in conversational tasks