Recruiting

Augmented Reality BCI

Sponsor:

Cognixion

Code:

NCT06810219

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognixion ONE

Study Details

Brief summary:

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:

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

Key measures include:

ITR - information transfer rate SUS - system usability scale

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Study ID

NCT06810219

Start date

Jan 20, 2025

Status verified date

Jan, 2025

Completion date

Oct 31, 2025

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Usability Study

Participants will utilize the Cognixion Axon-R device and associated communication software for practice and communication tasks as prescribed by the study administrator.

Interventions

Cognixion ONE

A wearable augmented reality brain computer interface with self contained computer and software to enable communication using the device input and output capabilities.

Primary outcome measure

  • System Usability Score [ Time Frame: 3 months from training and setup of device. ]
  • Information Transfer Rate (ITR) [ Time Frame: 3 months from training and setup of device. ]

Central Contacts and Locations

Central contacts

Christopher Principal Investigator

8053200774chris@cognixion.com

Cole Study Coordinator

214-907-6399cole@cognixion.com

Locations

Cognixion

Recruiting

Santa Barbara, California, United States, 93101-1665

Contacts

Chris Ullrich

8053200774chris@cognixion.com

Cole Study Coordinator

214-907-6399cole@cognixion.com

Principal Investigator:

Chris Principal Investigator

More Information

Sponsor

Cognixion

Last update posted

Feb 5, 2025

Last verified

Jan, 2025

Keywords

  • usability study
  • augmented reality
  • brain computer interface
  • Amyotrophic lateral sclerosis
  • als
  • generative AI
  • longitudinal study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cognixion on 2025-02-05.