Augmented Reality BCI Longitudinal Study for Persons with Late Stage ALS

Cognixion ALS BCI Longitudinal Study

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

Study Overview

• Status: Recruiting
• Conditions: ALS (Amyotrophic Lateral Sclerosis)
• Intervention / Treatment: Device: Cognixion ONE

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Principal Investigator; Phone Number: 8053200774; Email: chris@cognixion.com
• Study Contact Backup: Name: Cole Study Coordinator; Phone Number: 214-907-6399; Email: cole@cognixion.com

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93101-1665
      • Recruiting
      • Cognixion
      • Contact: Cole Study Coordinator; Phone Number: 214-907-6399; Email: cole@cognixion.com
      • Contact: Chris Ullrich; Phone Number: 8053200774; Email: chris@cognixion.com
      • Contact: Chris Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Score	A score ranging from 0 to 100 that captures the usability the device. This is an essential characteristic of a device feasibility study.	3 months from training and setup of device.
Information Transfer Rate (ITR)	The rate, in bits per minute, of information transfer for each of the device modalities. ITR is measured using a standardized selection procedure.	3 months from training and setup of device.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Words per Minute (WPM)	WPM is the number of words that a participant can speak in one minute. This statistic is calculated by counting the total time from partner utterance until a response is spoken by the participant.	3 months from training and setup of device.

Collaborators and Investigators

• Sponsor: Cognixion
• Investigators: Principal Investigator: Chris Principal Investigator, Cognixion

Publications and helpful links

General Publications

• Lewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590
• Kellmeyer P, Grosse-Wentrup M, Schulze-Bonhage A, Ziemann U, Ball T. Electrophysiological correlates of neurodegeneration in motor and non-motor brain regions in amyotrophic lateral sclerosis-implications for brain-computer interfacing. J Neural Eng. 2018 Aug;15(4):041003. doi: 10.1088/1741-2552/aabfa5. Epub 2018 Apr 20.
• Wolpaw JR, Bedlack RS, Reda DJ, Ringer RJ, Banks PG, Vaughan TM, Heckman SM, McCane LM, Carmack CS, Winden S, McFarland DJ, Sellers EW, Shi H, Paine T, Higgins DS, Lo AC, Patwa HS, Hill KJ, Huang GD, Ruff RL. Independent home use of a brain-computer interface by people with amyotrophic lateral sclerosis. Neurology. 2018 Jul 17;91(3):e258-e267. doi: 10.1212/WNL.0000000000005812. Epub 2018 Jun 27.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: augmented reality; Amyotrophic lateral sclerosis; longitudinal study; brain computer interface; als; usability study; generative AI
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: ALSUS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Usability insights related to this use case on this type of device will be shared with other accessibility and BCI researchers at conference events and through publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No