Santa Barbara – November 04, 2026 -- Cognixion Corporation is enrolling 30 US adults with amyotrophic lateral sclerosis (ALS) in the CHOICE study, which tests its wearable brain-computer interface (BCI) against the eye-tracking speech devices patients use today. The trial is registered on ClinicalTrials.gov as NCT07871071 and is funded entirely by federal money from the National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health.
Participants test three communication options at home over 12 weeks
Each participant uses their own eye-tracking speech generating tablet, a head-worn Cognixion BCI with augmented reality display glasses, and a touchscreen-based version of the Cognixion system. Participants choose which option to use in each session. The time they voluntarily spend with each is the study's primary outcome measure.
Secondary measures are communication speed and accuracy, usability, workload, quality of life and caregiver burden. Sessions take place in participants' homes with a trained caregiver present. Cognixion's study team handles setup, training and regular check-ins.
Cognixion's non-invasive system combines four technologies and does not depend on eye movement
The investigational system integrates a clinical-grade non-invasive BCI, optical see-through AR glasses, the proprietary AI Context Engine and a proprietary AI Digital Twin of each patient. It supports eye tracking and gaze detection alongside brain sensing, unlike some invasive BCI approaches that do not rely on eye movement in the same way. It can interoperate with participants' existing tablet-based speech generating devices but is designed to run independently of them.
Chris Ullrich, Cognixion's chief technology officer and the study's principal investigator, said the company's aim is to restore "dignity and agency" to people who have lost the ability to communicate. He added that the data should show a path to broader access to advanced technology and less physical and emotional burden on caregivers.
Eligibility requires a Tobii Dynavox or Smartbox device and a trainable caregiver
Eligible participants are adults aged 18 or older whose speech is significantly affected by ALS. They must have used a Tobii Dynavox or Smartbox eye-tracking speech generating device for at least 30 days, or be evaluating one. They also need a caregiver who can be trained and attend sessions. Participation is free.
Device remains investigational with no FDA clearance
The Cognixion BCI is not approved or cleared by the US Food and Drug Administration for any medical use, and the company gives no guarantee of benefit to participants. Participants may withdraw at any time, and their regular ALS care continues unchanged. The research is supported by NIH Award Number R44DC023888.