Brain-Computer Interface Communication Device for People With ALS

Part of paid clinical trials in Santa Barbara, California.

Sponsor
Cognixion
Study ID
NCT07871071
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Oct 13, 2026
Start date
Nov 15, 2026
Status verified
Oct 2026
Primary completion
Apr 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cognixion CorporationSanta BarbaraCalifornia93101-

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