Brain-computer interface chat tool for people with ALS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial uses the Cognixion ONE platform, which combines EEG-based brain input with multiple display options, to allow people with ALS to communicate. In a within-subject design, thirty adults with ALS will try three modalities over 12 weeks: their current eye-tracking device, the Cognixion ONE with an AR headset, and the Cognixion ONE with a screen. The study is conducted in participants’ homes with remote supervision and regular on-site visits, using a mixed modality approach that may include eye-tracking as a backup. The goal is to see whether the brain-computer interface can maintain or improve communication when eye movement becomes unreliable.

Why it matters

Who can join: the full rules

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

Where it's running

• Cognixion Corporation
  Santa Barbara, California, United States Recruiting

Study contacts

• Principal investigator: Chris Ullrich, M.Sc. — Cognixion Corporation
• Study coordinator: Cognixion Study Team
• Email: cognih001@cognixion.com
• Phone: 8332646496

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.