Cognixion ALS BCI Longitudinal Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cognixion
RECRUITING
Santa Barbara
Contact Information
Primary
Christopher Principal Investigator
chris@cognixion.com
8053200774
Backup
Cole Study Coordinator
cole@cognixion.com
214-907-6399
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 10
Treatments
Experimental: Usability Study
Participants will utilize the Cognixion Axon-R device and associated communication software for practice and communication tasks as prescribed by the study administrator.
Sponsors
Leads: Cognixion

This content was sourced from clinicaltrials.gov