Using augmented reality to improve communication for late stage ALS patients
Cognixion ALS BCI Longitudinal Study
NA · Cognixion · NCT06810219
This study is testing a new augmented reality device to see if it can help people with late stage ALS communicate better and more easily.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cognixion (industry) |
| Locations | 1 site (Santa Barbara, California) |
| Trial ID | NCT06810219 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the usability of a brain-computer interface (BCI) communication platform specifically designed for individuals with late stage ALS. Participants will receive the Cognixion Axon-R augmented reality device and associated software over a three-month period. The study will evaluate how quickly participants can learn to use the BCI, the effectiveness of alternative input methods like eye tracking, and the impact of AI-driven personalization on communication quality. Key metrics will include information transfer rate and system usability scale scores.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with late stage ALS who require an assistive communication device and can engage in basic eye movements.
Not a fit: Patients who have severe hearing impairments, significant vision disorders, or disruptions in English comprehension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve communication abilities for patients with late stage ALS, enhancing their quality of life.
How similar studies have performed: While there have been studies on BCIs for ALS, this specific approach using augmented reality and generative AI personalization is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Santa Barbara, California
- Cognixion — Santa Barbara, California, United States (RECRUITING)
Study contacts
- Principal investigator: Chris Principal Investigator — Cognixion
- Study coordinator: Christopher Principal Investigator
- Email: chris@cognixion.com
- Phone: 8053200774
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ALS, usability study, augmented reality, brain computer interface, Amyotrophic lateral sclerosis, als, generative AI, longitudinal study