Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System
Study Purpose:
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.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Brain Stem Stroke, Cerebral Palsy, Traumatic Brain Injury, Speech DisordersStudy Type:
Observational StudyStudy Category:
Study Status:
EnrollingPhase:
Not ApplicableStudy Chair(s)/Principal Investigator(s):
Katya Hill, PhD University of Pittsburgh
Clinicaltrials.gov ID (11 digit #):
NCT04026581Neals Affiliated?
NoCoordinating Center Contact Information
University of PittsburghKatya Hill, PhD / .(JavaScript must be enabled to view this email address) / 412-523-6424
.(JavaScript must be enabled to view this email address) Pittsburgh, Pennsylvania 15260 United States
Full Study Summary:
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.