Real World Testing of a Brain-Computer Interface

University of Pittsburgh

Status: Completed

Conditions: Traumatic Brain Injury; Speech Disorders; Cerebral Palsy; Amyotrophic Lateral Sclerosis; Brain Stem Stroke

Treatments: Behavioral: Speech generating device (SGD) evaluation including BCI access; Behavioral: Training and treatment

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04026581

STUDY19010094

90IFDV0002-01-00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

19 participants in 2 patient groups

Assessment

Description:

A comprehensive AAC assessment collecting clinical and personal data required to select a speech-generating device (SGD) is conducted along with a trial of three AAC technology solutions, followed by a trial for BCI access to an AAC system.

Treatment:

Behavioral: Speech generating device (SGD) evaluation including BCI access

Training and Treatment

Description:

AAC training and treatment services will be provided and communication performance outcomes monitored over the course of studying clinical treatment services. At monthly home visits the SLP gathers clinical and personal data on communication performance outcomes and user satisfaction of their AAC system and any alternative access methods.

Treatment:

Behavioral: Training and treatment