Clinical trial NCT06810219: Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS
Official title: Cognixion ALS BCI Longitudinal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ALS (Amyotrophic Lateral Sclerosis)
Keywords: usability study
augmented reality
brain computer interface
Amyotrophic lateral sclerosis
als
generative AI
longitudinal study
Lead sponsor: Cognixion
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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


Eligibility 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

Primary outcomes:
measure: System Usability Score
timeFrame: 3 months from training and setup of device.
measure: Information Transfer Rate (ITR)
timeFrame: 3 months from training and setup of device.
Secondary outcomes:
measure: Words per Minute (WPM)
timeFrame: 3 months from training and setup of device.
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Cognixion
state: California
Study officials:
affiliation: Cognixion
name: Chris Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590
citation: 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.
citation: 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.