💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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