Recruiting

Cognixion ONE vs. Eye-Tracking

Sponsor:

Cognixion

Code:

NCT07871071

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognixion ONE AR-BCI configuration

Cognixion ONE screen-based BCI configuration

Existing eye-gaze speech generating device

Study Details

Brief summary:

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.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT07871071

Start date

Nov 15, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Existing eye-gaze speech generating device

The participant's own commercial eye-gaze speech generating device (Tobii Dynavox or Smartbox Grid Pad with eye-gaze module), used in matched-task and free-conversation sessions throughout the window.

experimental: Cognixion ONE - AR-BCI configuration

Axon-R EEG assembly with a head-worn augmented-reality display (Apple Vision Pro or XReal AR glasses, selected per participant) running the Assisted Reality communication application.

experimental: Cognixion ONE - screen-based BCI configuration

Axon-R EEG assembly with an external screen display running the same Assisted Reality communication application. No head-worn display is used.

Interventions

Cognixion ONE AR-BCI configuration

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

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

The participant's own prescribed commercial eye-gaze speech generating device, used as the active within-subject comparator.

Primary outcome measure

  • Voluntary daily use time per input modality [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Cognixion Study Team

8332646496cognih001@cognixion.com

Locations

Cognixion Corporation

Recruiting

Santa Barbara, California, United States, 93101

Contacts

Chris Ullrich, M.Sc.

cognih001@cognixion.com

More Information

Sponsor

Cognixion

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • brain-computer interface
  • BCI
  • augmentative and alternative communication
  • AAC
  • speech generating device
  • augmented reality
  • electroencephalography
  • SSVEP
  • eye tracking
  • assistive technology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Cognixion on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.