Brain-Computer Interface Communication Device for People With ALS
ConditionAmyotrophic Lateral Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCognixion
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Cognixion ONE AR-BCI configuration
DeviceNon-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
DeviceThe same EEG sensing assembly and communication application presented on an external screen rather than a head-worn display.
Existing eye-gaze speech generating device
DeviceThe participant's own prescribed commercial eye-gaze speech generating device, used as the active within-subject comparator.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Existing eye-gaze speech generating deviceActive comparator 1 intervention
Group B: Cognixion ONE - AR-BCI configurationExperimental treatment 1 intervention
Group C: Cognixion ONE - screen-based BCI configurationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 weeksSecondary outcomes
1
Communication rate
Words per minute during structured communication tasks and free conversation, per modality.
Time frame
12 weeks2
Selection accuracy
Percent correct selections on the BCI Game ground-truth task. Benchmark: at least 80 percent accuracy on at least two BCI targets.
Time frame
12 weeks3
Information Transfer Rate
Bits per minute, computed from BCI Game performance and from communication-task throughput.
Time frame
12 weeks4
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.
Time frame
12 weeksOther outcomes
1
Sustained pure-BCI use after eye-gaze decline
Continued use of pure-BCI input among participants whose eye-gaze function declines during the study.
Time frame
12 weeks2
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.
Time frame
12 weeks3
Author-of-Record disclosure compliance
Rate of participant confirmation on AI-suggested phrases prior to the phrase being spoken.
Time frame
12 weeks4
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.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cognixion
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov
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