Amyotrophic Lateral SclerosisNCT07871071
Brain-Computer Interface Communication Device for People With ALS
A study testing Cognixion ONE AR-BCI configuration, Cognixion ONE screen-based BCI configuration and Existing eye-gaze speech generating device in people with Amyotrophic Lateral Sclerosis, run by Cognixion at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Cognixion ONE AR-BCI configuration, Cognixion ONE screen-based BCI configuration and Existing eye-gaze speech generating device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cognixion Corporation
Santa Barbara, California, 93101
Chris Ullrich, M.Sc., cognih001@cognixion.com
About this study
Official title: Within-Subject Longitudinal Evaluation of the Cognixion ONE Brain-Computer Interface Speech Generating Device in Individuals With ALS
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.
Read more
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.
Read the detailed description
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).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Cognixion ONE AR-BCI configuration, Cognixion ONE screen-based BCI configuration, Existing eye-gaze speech generating device
- Keywords
- brain-computer interface, BCI, augmentative and alternative communication, AAC, speech generating device, augmented reality, electroencephalography, SSVEP, eye tracking, assistive technology
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognixion ONE AR-BCI configurationDevice
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 configurationDevice
The same EEG sensing assembly and communication application presented on an external screen rather than a head-worn display.
Existing eye-gaze speech generating deviceDevice
The participant's own prescribed commercial eye-gaze speech generating device, used as the active within-subject comparator.
| Study group | Role | What they receive |
|---|---|---|
| Existing eye-gaze speech generating device | Active comparator | 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. Receives: Device: Existing eye-gaze speech generating device |
| Cognixion ONE - AR-BCI configuration | Experimental | 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. Receives: Device: Cognixion ONE AR-BCI configuration |
| Cognixion ONE - screen-based BCI configuration | Experimental | Axon-R EEG assembly with an external screen display running the same Assisted Reality communication application. No head-worn display is used. Receives: Device: Cognixion ONE screen-based BCI configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (10)
Communication rate
Words per minute during structured communication tasks and free conversation, per modality.
Measured: 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%
Measured: 12 weeks
Information Transfer Rate
Bits per minute, computed from BCI Game performance and from communication-task throughput.
Minimum: 0 bits/min, no maximum
Measured: 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.
Measured: 12 weeks
System Usability Scale (SUS)
Standardized 10-item usability instrument. Score range 0 to 100; higher scores indicate better usability.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and every 4 weeks through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Within-subject design. Every participant uses all three communication modalities across the 12-week window, in structured task blocks where modality is assigned by protocol and free-choice blocks where the participant selects. Sequence is not randomized.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cognixion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Chris Ullrich, M.Sc., Principal investigator, Cognixion Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871071
- Sponsor's protocol ID
- COG-NIH-001
- Other IDs
- 1R44DC023888-01A1
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
Publications
Wolpaw JR, Bedlack RS, Reda DJ, Ringer RJ, Banks PG, Vaughan TM, Heckman SM, McCane LM, Carmack CS, Winden S, McFarland DJ, Sellers EW, Shi H, Paine T, Higgins DS, Lo AC, Patwa HS, Hill KJ, Huang GD, Ruff RL. Independent home use of a brain-computer interface by people with amyotrophic lateral sclerosis. Neurology. 2018 Jul 17;91(3):e258-e267. doi: 10.1212/WNL.0000000000005812. Epub 2018 Jun 27.
PubMed 29950436Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, Nakanishi A. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct 31;169(1-2):13-21. doi: 10.1016/s0022-510x(99)00210-5.
PubMed 10540002