Cognixion ONE for ALS

Recruiting in Palo Alto (17 mi)

Overseen ByChris Principal Investigator

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Cognixion

No Placebo Group

Trial Summary

What is the purpose of 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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for up to 10 people with late-stage ALS in the Los Angeles area. Participants should be able to commit to a 3-month study period and are interested in using an augmented reality brain-computer interface (BCI) for communication.

Inclusion Criteria

I am 18 years old or older.

I have ALS and need help to communicate.

I can open my eyes and keep them open without help.

Exclusion Criteria

I am severely hearing impaired or deaf.

I have a history of epilepsy or seizures.

I do not have severe vision problems like glaucoma or double vision.

I have a history of vertigo or similar balance disorders.

Participant Groups

The Cognixion ONE, an augmented reality BCI with communication software, is being tested. The study aims to see how fast participants can learn it, its effectiveness compared to eye tracking, and if AI personalization improves communication.

1Treatment groups

Experimental Treatment

Group I: Usability StudyExperimental Treatment1 Intervention

Participants will utilize the Cognixion Axon-R device and associated communication software for practice and communication tasks as prescribed by the study administrator.