Cognixion ONE for ALS

Overseen By Cole Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cognixion

Disqualifiers: Aphasia, Deaf, Epilepsy, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

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.

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

Research Team

Chris Principal Investigator

Principal Investigator

Cognixion

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 have someone who can learn to use the Cognixion system for me.

Fluent in understanding English

I have ALS and need help to communicate.

Exclusion Criteria

Sensitivity to flashing lights

Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)

I have a history of epilepsy or seizures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Setup

Participants receive training and setup of the Cognixion Axon-R device and associated communication software

2 weeks

Usability Study

Participants utilize the Cognixion Axon-R device and associated communication software for practice and communication tasks

3 months

Follow-up

Participants are monitored for safety and effectiveness after the usability study

4 weeks

Treatment Details

Interventions

• Cognixion Axon-R

Trial Overview 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.

Participant Groups

Group I: Usability Study Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Cognixion

Lead Sponsor

Trials

1

Recruited

10+