Real World Testing of a Brain-Computer Interface

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

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 Overview

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

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 Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

• Study Contact: Name: Katya Hill, PhD; Phone Number: 412-523-6424; Email: khill@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Carnegie, Pennsylvania, United States, 15102
      • AAC Institute Clinic (ICAN Talk Clinic)
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh, AAC Performance and Testing Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with severe communication disabilities and minimal movement impairment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Assessment; 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.	Behavioral: Speech generating device (SGD) evaluation including BCI access; At the initial evaluation the participants will review the full range of AAC options and speech generating devices (SGDs) and complete a speech and language evaluation. The second evaluation date will involve a trial of SGDs matched to the participant's assessment results. The third visit is the trial of an AAC system with BCI access. Should the dry electrode headgear for BCI access prove ineffective, then the gel electrode cap will be offered to the participant for trial. At the end of the third visit, the evaluation results will be discussed with participant and family, and they will be asked to select the preferred SGD.
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.	Behavioral: Training and treatment; Participants receive training on the selected SGD followed by monthly treatment sessions from the SLP who monitors performance. In some cases the participants' SGD will be an AAC system with BCI access. In this case training will also include an identified system support person. Use of the SGD is monitored on a monthly basis through home visits and/or tele-practice sessions, when requested. Technical support for the SGD is provided on an as needed basis or when requested by the participant or support person.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	Baseline vs. 1 month
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	1 month vs. 2 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	2 months vs. 3 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	3 months vs. 4 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	4 months vs. 5 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	5 months vs. 6 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	6 months vs. 7 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	7 months vs. 8 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	8 months vs. 9 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	9 months vs. 10 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	10 months vs. 11 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	11 months vs. 12 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	12 months vs. 13 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	13 months vs. 14 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	14 months vs. 15 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	15 months vs. 16 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	16 months vs. 17 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	17 months vs. 18 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	18 months vs. 19 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	19 months vs. 20 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	20 months vs. 21 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	21 months vs. 22 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	22 months vs. 23 months
Change in daily communication performance	Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.	23 months vs. 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	Baseline vs. 1 month
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	1 month vs. 2 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	2 months vs. 3 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	3 months vs. 4 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	4 months vs. 5 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	5 months vs. 6 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	6 months vs. 7 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	7 months vs. 8 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	8 months vs. 9 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	9 months vs. 10 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	10 months vs. 11 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	11 months vs. 12 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	12 months vs. 13 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	13 months vs. 14 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	14 months vs. 15 months
User satisfaction of speech generating device (SGD) or daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	15 months vs. 16 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	16 months vs. 17 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	17 months vs. 18 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	18 months vs. 19 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	19 months vs. 20 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	20 months vs. 21 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	21 months vs. 22 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	22 months vs. 23 months
User satisfaction of speech generating device (SGD) for daily communication	Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.	23 months vs. 24 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Principal Investigator: Katya Hill, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Brain Damage, Chronic; Neuromuscular Diseases; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Ischemia; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Infarction; Stroke; Brain Infarction; Language Disorders; Communication Disorders; Cerebral Palsy; Brain Injuries; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Brain Injuries, Traumatic; Speech Disorders; Brain Stem Infarctions
• Other Study ID Numbers: STUDY19010094; 90IFDV0002-01-00 (Other Grant/Funding Number: NIDILRR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No