Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS
ConditionALS (Amyotrophic Lateral Sclerosis)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCognixion
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Cognixion ONE
DeviceA wearable augmented reality brain computer interface with self contained computer and software to enable communication using the device input and output capabilities.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Usability StudyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months from training and setup of device.2
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.
Time frame
3 months from training and setup of device.Secondary outcomes
1
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.
Time frame
3 months from training and setup of device. Source ClinicalTrials.gov