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Cognixion enrolls 30 adults with ALS in NIH-funded brain-computer interface study

Cognixion is enrolling 30 adults with ALS who use Tobii Dynavox or Smartbox eye-tracking devices in a 12-week home study of its brain-computer interface, the company said. The ClinicalTrials.gov record lists the study as recruiting at one site in Santa Barbara, California.

By The Priority Review desk

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Cognixion Corporation is now enrolling 30 adults with amyotrophic lateral sclerosis (ALS) in the CHOICE study, a comparison of its investigational wearable brain-computer interface with the eye-tracking communication devices participants already use, the company said on Nov. 4, 2026. The study, registered as NCT07871071, is supported by the National Institute on Deafness and Other Communication Disorders. Sessions take place in participants' homes with a trained caregiver present, the company said, and the record says recruitment partners provide referrals only.

Estimated study timeline
  1. Estimated start date 2026-11-15
  2. Estimated primary completion date 2028-04
  3. Estimated completion date 2029-06

From the ClinicalTrials.gov record NCT07871071.

Why it matters

The ClinicalTrials.gov record lists Cognixion as lead sponsor and the National Institute on Deafness and Other Communication Disorders as collaborator. It describes the study as non-randomized, with a crossover model and phase listed as NA. The record says the device is an investigational research device that is not approved or cleared by the U.S. Food and Drug Administration for any medical use. It also says the study builds on a completed Phase 1 feasibility study, NCT07209943.

Who the study is looking for

The company described the eligible group as adults 18 or older with ALS whose speech is significantly affected, who use a Tobii Dynavox or Smartbox eye-tracking speech generating device for at least 30 days or are in the process of evaluating one, and who have a caregiver who can be trained and present for sessions. The company said there is no cost to participate.

The record's inclusion criteria add these conditions:

  • An ALS diagnosis established by a neurologist, meeting either the Gold Coast Criteria or the revised El Escorial criteria.
  • An ALSFRS-R Speech subscale score of 3 or lower.
  • A designated caregiver able to complete a 2-hour onboarding and a Month-3 refresher.
  • Volitional eye opening sustained independently for at least 30 minutes.
  • A reliable communication method other than the study device for affirmative assent, at minimum a yes/no channel.

Exclusion criteria in the record include a history of photosensitive epilepsy or active seizure disorder, vertigo or other vestibular disorders, and concurrent enrollment in another investigational communication-device or brain-computer interface trial.

Study design and timeline

The record lists an estimated enrollment of 30. Each participant uses three options over 12 weeks: their own eye-gaze speech generating device as the active comparator, 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 by protocol, and for others the participant chooses.

The primary outcome is voluntary daily use time per input modality, in minutes per day, captured from device telemetry over 12 weeks. The company said how much time participants voluntarily spend with each option is the study's primary outcome measure. Secondary outcomes in the record include communication rate, selection accuracy, System Usability Scale scores, NASA Task Load Index, quality of life and caregiver burden through the Zarit Burden Interview.

The record lists an estimated start date of 2026-11-15, an estimated primary completion date of 2028-04 and an estimated completion date of 2029-06. Its overall status is RECRUITING, with one location, Cognixion Corporation in Santa Barbara, California. The record says enrollment is rolling across the first 18 months of a 36-month period of performance, and that recruitment partners provide referrals only and do not execute study activities.

Funding and contacts

The company said the research is supported by the National Institute on Deafness and Other Communication Disorders under Award Number R44DC023888 and that the project is 100 % funded by federal funds from that institute. The record describes the study as funded under SBIR award R44DC023888.

People with ALS, caregivers and clinicians can reach the study team by email at theCHOICEstudy@cognixion.com or by phone at (833) 264-6496 ext. 702, the company said. The record lists the principal investigator as Chris Ullrich of Cognixion Corporation.

Sources