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 Disorders

Study Type:

Observational Study

Study Category:

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Katya Hill, PhD University of Pittsburgh

Clinicaltrials.gov ID (11 digit #):

NCT04026581

Neals Affiliated?

No

Coordinating Center Contact Information

University of Pittsburgh
Katya 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.

Study Sponsor:

University of Pittsburgh

Participant Duration:

Estimated Enrollment:

20

Estimated Study Start Date:

06/05/2019

Estimated Study Completion Date:

08/31/2023

Posting Last Modified Date:

07/25/2019

Date Study Added to alsconsortium.org:

07/25/2019
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    14

    Maximum Age:

    N/A

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?


    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

  • Site Contact Information

    AAC Institute Clinic (ICAN Talk Clinic)
    Shannon Carney / .(JavaScript must be enabled to view this email address) / 412-489-5527
    Carnegie, Pennsylvania 15102
    United States

    University of Pittsburgh, AAC Performance and Testing Laboratory
    Katya Hill, PhD / .(JavaScript must be enabled to view this email address) / 412-523-6424
    Pittsburgh, Pennsylvania 15260
    United States