MedTrace Logo

Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

NCT06810219 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-02-05

No results posted yet for this study

Summary

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

Conditions

  • ALS (Amyotrophic Lateral Sclerosis)

Interventions

DEVICE

Cognixion ONE

A wearable augmented reality brain computer interface with self contained computer and software to enable communication using the device input and output capabilities.

Sponsors & Collaborators

  • Cognixion

    lead INDUSTRY

Principal Investigators

  • Chris Principal Investigator · Cognixion

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-08-30
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06810219 on ClinicalTrials.gov