NCT07871071Recruiting
Brain-Computer Interface Communication Device for People With ALS
Within-Subject Longitudinal Evaluation of the Cognixion ONE Brain-Computer Interface Speech Generating Device in Individuals With ALS
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 7 Oct 2026
- Start date
- 15 Nov 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Cognixion
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07871071
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 15 Nov 2026 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent enrollment in another investigational communication-device or brain-computer interface trial
Other illness
- 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
- 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
- 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
- Severe hearing impairment or deafness that would prevent participation in conversational tasks
Other
- Active hospice enrollment without documented capacity to participate in research activities
- Sensitivity to flashing lights
- Claustrophobia related to head-mounted display use, after attempted accommodation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cognixion Corporation Coordinator of this site? Confirm its status | Santa Barbara | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.