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Cognixion Device for Communication in ALS, TBI, and SCI

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What is being tested

Cognixion + Apple Vision Pro

Device
Who is being recruted

ALS (Amyotrophic Lateral Sclerosis)
+1

+ TBI Traumatic Brain Injury
+ SCI - Spinal Cord Injury
Over 18 Years

See all eligibility criteria

How is the trial designed

Device Feasibility Study

Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorCognixion
Study ContactChristopher Ullrich, M.Sc.
Last updated: October 7, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 16, 2025Actual date on which the first participant was enrolled.

This study is focused on enhancing a special communication platform that uses brain-computer interface (BCI) technology. It targets individuals with late-stage conditions like ALS, traumatic brain injury, or spinal cord injury who need help with communication and computer use. Up to 10 participants will be involved, each using a Cognixion device integrated with Apple Vision Pro, which includes augmented reality and communication software. The aim is to see how well these individuals can use this system to communicate, learn to use new communication methods, and improve their interaction abilities over time. This research is essential as it could lead to better communication solutions for people with severe communication challenges. Participants in the study will use the Cognixion-Apple Vision Pro system for 3 to 4 months. The device, which involves brainwave, eye-tracking, and other inputs, will help researchers assess how effectively it enables communication. The study will evaluate several factors, such as how well users can learn to operate the system, the effectiveness of different input methods, and how personalization improves communication. Researchers will measure outcomes like the information transfer rate and user satisfaction to determine the system's usability. This study hopes to optimize these technologies to better meet the needs of users, potentially improving their independence and quality of life.

Official TitleCognixion Pass Through Study 
Principal SponsorCognixion
Study ContactChristopher Ullrich, M.Sc.
Last updated: October 7, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
10 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Device Feasibility Study
These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
ALS (Amyotrophic Lateral Sclerosis)
TBI Traumatic Brain Injury
SCI - Spinal Cord Injury
Stroke
Criteria

Inclusion criteria: * Must have a designated on-site support individual who can be trained on the Cognixion system * Fluent in understanding English * 18 years or older * Must have one of ALS, spinal cord injury or chronic brain injury and need an assistive communication device * Must be able to engage in volitional eye opening and sustain eye opening independently for at least 30 minutes. * 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, independent 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 * Claustrophobia related to the Apple Vision Pro with comfort adapter * 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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants will utilize the Cognixion + Apple Vision Pro device and associated communication and computer control software for practice and communication tasks as prescribed by the study administrator. Various modalities, including pure BCI and ET-BCI will be available to users.
Study Objectives
Primary Objectives

A score ranging from 0 to 100 that captures the usability the device and enables it to be compared with other human machine interface devices. This is an intrisic property of the device interface (hardware/software) and is not a healh outcome measure.

The rate, in bits per minute, of information transfer for each of the device modalities. ITR is measured using a standardized selection procedure and is a measure the captures how efficient the device interface is. It is an essential measure of device throughput and is not related to any health outcome.
Secondary Objectives

PPM is the number of complete phrases or compute rcommands that the user can construct in 1 minute. This is a usage metric that captures the efficiency of the device in predicting user utterances and does not relate to any health outcome.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Cognixion HQSanta Barbara, United StatesSee the location
Recruiting soonOne Study Center