Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Change in daily communication performance
Study Overview
Brief Summary
The goal of this project is to test a new AAC-BCI device comparing gel and dry electrode headgear used for communication while providing clinical care. Innovative resources will be employed to support the standard of care without considering limitations based on service billing codes. Clinical services will include AAC assessment, AAC-BCI device and treatment to individuals with minimal movement due to amyotrophic lateral sclerosis (ALS), brain stem strokes, severe cerebral palsy, traumatic brain injury (TBI) and their family support person. This is a descriptive study designed to measure and monitor the communication performance of individuals using the AAC-BCI, any other AAC strategies, their user satisfaction and perceptions of communication effectiveness, and the satisfaction of the family support persons.
Detailed Description
This clinical trial follows a descriptive study design collecting data to measure and monitor variables related to the standard of care in providing speech language pathology augmentative and alternative communication clinical (AAC) assessment and treatment. The study tracks participants through the AAC, speech generating device trial and AAC-BCI trial processes. In addition this study measures and monitors the communication performance of individuals using the AAC-BCI and any other AAC strategies for treatment in the home. Data on communication performance, user satisfaction, and perceptions of communication effectiveness are gathered over monthly visits along with the satisfaction and perceptions of communication effectiveness by the family support persons.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •natural speech does not meet daily communication needs requiring using a speech generating device
- •Has a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display
- •age 14 and above
- •able to read a standard computer screen
- •able to follow instructions
- •English as their native language
Exclusion Criteria
- •history of photosensitive epilepsy
- •open sores on the scalp
- •history of uncorrectable hearing loss
- •unavailable to participate during the times scheduled for the study
Outcomes
Primary Outcomes
Change in daily communication performance
Time Frame: 23 months vs. 24 months
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Secondary Outcomes
- User satisfaction of speech generating device (SGD) for daily communication(23 months vs. 24 months)
- User satisfaction of speech generating device (SGD) or daily communication(15 months vs. 16 months)
Investigators
Katya Hill
Associate Professor
University of Pittsburgh