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.

Study Status:

Recruiting

Disease:

Amyotrophic Lateral Sclerosis , Brain Stem Stroke , Cerebral Palsy , Traumatic Brain Injury , Speech Disorders

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

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

Katya Hill, PhD, University of Pittsburgh

Clinicaltrials.gov ID:

NCT04026581

Neals Affiliated?

No

Coordinating Center Contact Information

University of Pittsburgh

Katya Hill, PhD / email hidden; JavaScript is required / 412-523-6424

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

Estimated Enrollment:

20

Estimated Study Start Date:

06 / 05 / 2019

Estimated Study Completion Date:

08 / 31 / 2023

Posting Last Modified Date:

10 / 07 / 2022

Date Study Added to neals.org:

07 / 19 / 2019

Minimum Age:

14 Years

Maximum Age:

N/A

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

AAC Institute Clinic (ICAN Talk Clinic) | Recruiting

Shannon Carney / 412-489-5527 / email hidden; JavaScript is required

Carnegie, Pennsylvania 15102
United States

University of Pittsburgh, AAC Performance and Testing Laboratory | Recruiting

Katya Hill, PhD / 412-523-6424 / email hidden; JavaScript is required

Pittsburgh, Pennsylvania 15260
United States