Clinical Research Directory

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