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Brain-Computer Interface Communication Device for People With ALS

Sponsor: Cognixion • ClinicalTrials.gov ID: NCT07871071

Registry updated: 2026-10-16

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Description

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.

Interventions

Cognixion ONE AR-BCI configuration (Device)
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.
Cognixion ONE screen-based BCI configuration (Device)
The same EEG sensing assembly and communication application presented on an external screen rather than a head-worn display.
Existing eye-gaze speech generating device (Device)
The participant's own prescribed commercial eye-gaze speech generating device, used as the active within-subject comparator.

Eligibility criteria

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

Conditions

Amyotrophic Lateral Sclerosis

Locations

Cognixion Corporation — Santa Barbara, California, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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