Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

NCT06810219 | Recruiting FDA Device

• 1 other identifier: ALSUS1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Words per Minute (WPM)

  3 months from training and setup of device.

Study Arms (1)

Usability Study

EXPERIMENTAL

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

Interventions

Cognixion ONE DEVICE

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

Usability Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Cognixion: lead

Study Sites (1)

Cognixion

Santa Barbara, California, 93101-1665, United States

RECRUITING

Related Publications (3)

• Lewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590

  BACKGROUND

• 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.

  PMID: 29676287 BACKGROUND

• 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.

  PMID: 29950436 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chris Principal Investigator

  Cognixion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Principal Investigator

CONTACT

8053200774; chris@cognixion.com

Cole Study Coordinator

CONTACT

214-907-6399; cole@cognixion.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 5, 2025
• Study Start: January 20, 2025
• Primary Completion: August 30, 2025
• Study Completion: October 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)