Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    20
  • sponsor
    University of Pittsburgh
Updated on 24 October 2022
stroke
cerebral palsy
traumatic brain injury
primary lateral sclerosis
amyotrophic lateral sclerosis

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.

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.

Details
Condition Amyotrophic Lateral Sclerosis, Brain Stem Stroke, Cerebral Palsy, Traumatic Brain Injury, Speech Disorders
Treatment Speech generating device (SGD) evaluation including BCI access, Training and treatment
Clinical Study IdentifierNCT04026581
SponsorUniversity of Pittsburgh
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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