Real World Testing of a Brain-Computer Interface
2 other identifiers
observational
19
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2019
CompletedFirst Submitted
Initial submission to the registry
July 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedDecember 6, 2023
December 1, 2023
4.3 years
July 17, 2019
December 5, 2023
Conditions
Outcome Measures
Primary Outcomes (24)
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 Outcomes (24)
User satisfaction of speech generating device (SGD) for daily communication
Baseline vs. 1 month
User satisfaction of speech generating device (SGD) for daily communication
1 month vs. 2 months
User satisfaction of speech generating device (SGD) for daily communication
2 months vs. 3 months
User satisfaction of speech generating device (SGD) for daily communication
3 months vs. 4 months
User satisfaction of speech generating device (SGD) for daily communication
4 months vs. 5 months
- +19 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
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.
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.
Eligibility Criteria
Individuals with severe communication disabilities and minimal movement impairment.
You may qualify if:
- 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
You may not qualify if:
- history of photosensitive epilepsy
- open sores on the scalp
- history of uncorrectable hearing loss
- unavailable to participate during the times scheduled for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
AAC Institute Clinic (ICAN Talk Clinic)
Carnegie, Pennsylvania, 15102, United States
University of Pittsburgh, AAC Performance and Testing Laboratory
Pittsburgh, Pennsylvania, 15260, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katya Hill, PhD
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 17, 2019
First Posted
July 19, 2019
Study Start
June 5, 2019
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
December 6, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 9 months and ending 36 months following article publication.
- Access Criteria
- Investigators whose proposed use of the data has been approved by an independent review committee.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)