An interventional study of Cognixion ONE AR-BCI configuration and Cognixion ONE screen-based BCI configuration in Amyotrophic Lateral Sclerosis, sponsored by Cognixion. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Cognixion · Not applicable, Interventional, and Supportive care
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.
Within-subject longitudinal evaluation. Each participant serves as their own control and uses all three modalities across a 12-week primary endpoint window: (a) their existing commercial eye-gaze speech generating device as the active comparator, (b) the Cognixion ONE AR-BCI configuration, and (c) the Cognixion ONE screen-based BCI configuration. Letterboard is retained as a within-subject fallback for participants whose eye-gaze becomes non-viable during the window.
The Cognixion ONE platform combines a constant medical-grade EEG sensing assembly (Axon-R, IEC 60601 certified) with one of three interchangeable display configurations - an Apple Vision Pro augmented-reality headset, XReal augmented-reality glasses, or an external screen - and a Cognixion-developed AI-assisted communication application. Selection is made by steady-state visual evoked potential response, optionally combined with eye tracking as a hybrid modality. Display configuration is selected per participant and may be changed during the study under documented criteria with participant re-consent.
All study activity is conducted by Cognixion personnel in participants' homes, with weekly remote supervision and at-least-monthly on-site visits. Recruitment partners provide referrals only and do not execute study activities. Sessions run 3 to 5 times per week at approximately one hour each, with a trained caregiver present for all sessions using the study device.
Enrollment is rolling across the first 18 months of a 36-month period of performance. Disease progression is tracked by the complete 12-item ALSFRS-R at baseline and every 4 weeks, entering the primary statistical model as a time-varying covariate.
The study is funded by the National Institute on Deafness and Other Communication Disorders under SBIR award R44DC023888, and builds on a completed Phase 1 feasibility study (NCT07209943).
1,000 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 284 are open to participants now.
This study's planned enrollment of 30 is below the median of 37 across 678 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →Cognixion is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Existing eye-gaze speech generating device
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.
Device: Cognixion ONE AR-BCI configuration
Axon-R EEG assembly with an external screen display running the same Assisted Reality communication application. No head-worn display is used.
Device: Cognixion ONE screen-based 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.
The same EEG sensing assembly and communication application presented on an external screen rather than a head-worn display.
The participant's own prescribed commercial eye-gaze speech generating device, used as the active within-subject comparator.
Voluntary daily use time per input modality
Minutes per day of voluntary use of each of the three communication modalities, captured from device telemetry. Measures user preference across available options, and is robust to learning effects, communication-partner effects, and prompt-driven artifacts that bias single-session performance measures. Minmum:0mins/day Maximum: 1440mins/day
Time frame: 12 weeks
Communication rate
Words per minute during structured communication tasks and free conversation, per modality.
Time frame: 12 weeks
Selection accuracy
Percent correct selections on the BCI Game ground-truth task. Benchmark: at least 80 percent accuracy on at least two BCI targets. Range: 0-100%
Time frame: 12 weeks
Information Transfer Rate
Bits per minute, computed from BCI Game performance and from communication-task throughput. Minimum: 0 bits/min, no maximum
Time frame: 12 weeks
Modality preference and time allocation
Fraction of voluntary use time spent in each input mode: pure BCI, hybrid eye-tracking plus BCI, eye tracking, and switch control. Normalized value: 0-1.0 for each modality.
Time frame: 12 weeks
System Usability Scale (SUS)
Standardized 10-item usability instrument. Score range 0 to 100; higher scores indicate better usability.
Time frame: Baseline and multiple longitudinal time points through 12 weeks
NASA Task Load Index (NASA-TLX)
Six-subscale cognitive workload assessment administered after structured task sessions. Higher scores indicate greater workload. Score range: 0-100
Time frame: 12 weeks
ALS-Specific Quality of Life Instrument, Short Form (ALSSQOL-SF)
Validated ALS-specific quality of life measure. Higher scores indicate better quality of life. Range: 0-10
Time frame: Baseline and 12 weeks
Zarit Burden Interview (ZBI)
Caregiver burden assessment administered to the designated caregiver. Higher scores indicate greater burden. Score range: 0-88
Time frame: Baseline and 12 weeks
Conversation metrics
Turn-taking dynamics, dialog efficiency, AI suggestion-acceptance rate, and vocabulary diversity (type-token ratio). Normalized scores: 0-1
Time frame: 12 weeks
Disease progression (ALSFRS-R)
Complete 12-item ALS Functional Rating Scale - Revised. Score range 0 to 48; higher scores indicate better function. Evaluator-administered at baseline, validated self-entry version thereafter. Score range: 0-48
Time frame: Baseline and every 4 weeks through 12 weeks
Sustained pure-BCI use after eye-gaze decline
Continued use of pure-BCI input among participants whose eye-gaze function declines during the study. Observational
Time frame: 12 weeks
Caregiver setup time
Time for the caregiver to set up the device for a session. Target is 5 minutes or less by end of cohort onboarding. Minimum is 1min, no maximum.
Time frame: 12 weeks
Author-of-Record disclosure compliance
Rate of participant confirmation on AI-suggested phrases prior to the phrase being spoken. Normalized score: 0-1
Time frame: 12 weeks
Articulatory precision trajectory
Within-person rate of change in articulatory precision from a weekly recorded reading passage, and its concordance with the ALSFRS-R speech item, bulbar subdomain, and total score. Analyzed within the speech-analytic evaluable subset. Normalized: 0-1
Time frame: 12 weeks
Time to loss of measurable speech
Time from enrollment to the last scorable speech session, within the speech-analytic evaluable subset. Censored at Week 12 or withdrawal. Days from start of study.
Time frame: 12 weeks
Plan to share: Yes — Open access: Raw EEG from BCI Calibration task Controlled Access: Communication metrics, survesy, ALSFRS-R scores, modality telemetry, deidentified adverse event tables, speech scores
Supporting information: Study protocol, Clinical study report
Time frame: IPD and supporting information will be available from 03/2029 for at least 12 months
Access criteria: Raw EEG data - unrestricted All other - NIH designated controlled access repository
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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