RECRUITING

Augmented Reality BCI Longitudinal Study for Persons with Late Stage ALS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Cognixion ALS BCI Longitudinal Study

Quick Facts

Study Start:2025-01-20
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06810219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have someone (LAR) who can consent to their participation and who will be present in the study alongside the participant
  2. * Must have a designated individual who can be trained on the Cognixion system
  3. * Fluent in understanding English
  4. * 18 years or older
  5. * Must have ALS and need an assistive communication device
  6. * Must be able to engage in volitional eye opening and sustain eye opening independently for x duration
  7. * 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"
  1. * Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)
  2. * Severely hearing impaired or deaf
  3. * Sensitivity to flashing lights
  4. * History of epilepsy and/or seizures
  5. * Vision disorders restricting the visual field such as glaucoma, diplopia (double vision), nystagmus (involuntary eye movements)
  6. * History of vertigo or other vestibular disorders
  7. * Scalp that is prone to irritation, inflammation, injury, or infectious process

Contacts and Locations

Study Contact

Christopher Principal Investigator
CONTACT
8053200774
chris@cognixion.com
Cole Study Coordinator
CONTACT
214-907-6399
cole@cognixion.com

Principal Investigator

Chris Principal Investigator
PRINCIPAL_INVESTIGATOR
Cognixion

Study Locations (Sites)

Cognixion
Santa Barbara, California, 93101-1665
United States

Collaborators and Investigators

Sponsor: Cognixion

  • Chris Principal Investigator, PRINCIPAL_INVESTIGATOR, Cognixion

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-20
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2025-01-20
Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • ALS (Amyotrophic Lateral Sclerosis)