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Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Cognixion · NCT06810219

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
10
US sites recruiting
1
Study start
January 20, 2025
Record last updated
February 5, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The goal of this study is refine the usability of a BCI based communication platform.

The study will take place in the greater Los Angeles area and will enroll up to 10 participants with late stage ALS. Each subject will receive a Cognixion Axon-R augmented reality brain computer interface and associated communication software. The study duration is 3 months for each participant.

The key questions that will be addressed in this study are:

  • How quickly can participants learn and gain confidence with a pure BCI interface.
  • How effective are alternate input modalities including eye tracking for this use case.
  • Identify the extent to which generative AI based personalization impacts the communication quality.

Key measures include

ITR - information transfer rate SUS - system usability scale

Being studied: Cognixion ONE

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion criteria

  • Must have someone (LAR) who can consent to their participation and who will be present in the study alongside the participant
  • Must have a designated individual who can be trained on the Cognixion system
  • Fluent in understanding English
  • 18 years or older
  • Must have ALS and need an assistive communication device
  • Must be able to engage in volitional eye opening and sustain eye opening independently for x duration
  • Must have a way to communicate apart from using the Cognixion device such as vocalizations, head nod, eye blinks, eyebrow raises, etc. At a minimum, reliable way of communicating "Yes" and "No"

Exclusion criteria

  • Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)
  • Severely hearing impaired or deaf
  • Sensitivity to flashing lights
  • History of epilepsy and/or seizures
  • Vision disorders restricting the visual field such as glaucoma, diplopia (double vision), nystagmus (involuntary eye movements)
  • History of vertigo or other vestibular disorders
  • Scalp that is prone to irritation, inflammation, injury, or infectious process

Recruiting US locations

  • Cognixion

    Santa Barbara, CA 93101-1665

    Site contact: Chris Ullrich · 8053200774 · chris@cognixion.com

Study contacts (from the official record)

  • Christopher Principal Investigator · 8053200774 · chris@cognixion.com
  • Cole Study Coordinator · 214-907-6399 · cole@cognixion.com
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Augmented Reality BCI Longitudinal Study for Persons With Late… (NCT06810219) | Bored Studies