Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Cognixion ONE AR-BCI configuration for Amyotrophic Lateral Sclerosis

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.

Official registry: https://clinicaltrials.gov/study/NCT07871071 · Cognixion · enrollment listed as 30

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Cognixion ONE AR-BCI configuration, Cognixion ONE screen-based BCI configuration, or Existing eye-gaze speech generating device. The registry lists allocation as randomized. This study compares a wearable brain-computer interface (BCI) communication device with the eye-tracking communication devices that people with ALS already use.

They plan to enroll about 30 people at Santa Barbara. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Within-Subject Longitudinal Evaluation of the Cognixion ONE Brain-Computer Interface Speech Generating Device in Individuals With ALS

Interventions: Cognixion ONE AR-BCI configuration, Cognixion ONE screen-based BCI configuration, Existing eye-gaze speech generating device

Primary outcome (registry wording): Voluntary daily use time per input modality

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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)
  • 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

Public study contact (from the registry)

Cognixion Study Team

8332646496

cognih001@cognixion.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07871071 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07871071?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07871071?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary