Cognixion Device for Communication in ALS, TBI, and SCI
Cognixion + Apple Vision Pro
Brain Injuries, Traumatic+19
+ Amyotrophic Lateral Sclerosis
+ Brain Diseases
Device Feasibility Study
Summary
Study start date: October 16, 2025
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Device Feasibility Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
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