Real World Testing of a Brain-Computer Interface

Completed

• Conditions: Speech Disorders; Brain Stem Stroke; Cerebral Palsy; Amyotrophic Lateral Sclerosis; Traumatic Brain Injury
• Interventions: Behavioral: Training and treatment; Behavioral: Speech generating device (SGD) evaluation including BCI access

• Registration Number: NCT04026581
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-06-05
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training and Treatment	Training and treatment	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.
Assessment	Speech generating device (SGD) evaluation including BCI access	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.

Primary Outcome Measures

Name	Time	Method
Change in daily communication performance	23 months vs. 24 months	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

Secondary Outcome Measures

Name	Time	Method
User satisfaction of speech generating device (SGD) for daily communication	23 months vs. 24 months	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) or daily communication	15 months vs. 16 months	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

Trial Locations

Locations (2)

AAC Institute Clinic (ICAN Talk Clinic); 🇺🇸 Carnegie, Pennsylvania, United States

University of Pittsburgh, AAC Performance and Testing Laboratory; 🇺🇸 Pittsburgh, Pennsylvania, United States