Real World Testing of a Brain-Computer Interface

• ClinicalTrials.gov Identifier: NCT04026581
• Recruitment Status: Recruiting
• First Posted: July 19, 2019
• Last Update Posted: October 7, 2022
• Sponsor: University of Pittsburgh
• Collaborator: National Institute on Disability, Independent Living, and Rehabilitation Research
• Information provided by (Responsible Party): Katya Hill, University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment
Amyotrophic Lateral Sclerosis; Brain Stem Stroke; Cerebral Palsy; Traumatic Brain Injury; Speech Disorders	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 Design

• Study Type: Observational
• Estimated Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System
• Actual Study Start Date: June 5, 2019
• Estimated Primary Completion Date: August 31, 2023
• Estimated Study Completion Date: August 31, 2023

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Change in daily communication performance [ Time Frame: Baseline vs. 1 month ]
   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. Change in daily communication performance [ Time Frame: 1 month vs. 2 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.
3. Change in daily communication performance [ Time Frame: 2 months vs. 3 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.
4. Change in daily communication performance [ Time Frame: 3 months vs. 4 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.
5. Change in daily communication performance [ Time Frame: 4 months vs. 5 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.
6. Change in daily communication performance [ Time Frame: 5 months vs. 6 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.
7. Change in daily communication performance [ Time Frame: 6 months vs. 7 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.
8. Change in daily communication performance [ Time Frame: 7 months vs. 8 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.
9. Change in daily communication performance [ Time Frame: 8 months vs. 9 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.
10. Change in daily communication performance [ Time Frame: 9 months vs. 10 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.
11. Change in daily communication performance [ Time Frame: 10 months vs. 11 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.
12. Change in daily communication performance [ Time Frame: 11 months vs. 12 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.
13. Change in daily communication performance [ Time Frame: 12 months vs. 13 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.
14. Change in daily communication performance [ Time Frame: 13 months vs. 14 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.
15. Change in daily communication performance [ Time Frame: 14 months vs. 15 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.
16. Change in daily communication performance [ Time Frame: 15 months vs. 16 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.
17. Change in daily communication performance [ Time Frame: 16 months vs. 17 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.
18. Change in daily communication performance [ Time Frame: 17 months vs. 18 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.
19. Change in daily communication performance [ Time Frame: 18 months vs. 19 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.
20. Change in daily communication performance [ Time Frame: 19 months vs. 20 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.
21. Change in daily communication performance [ Time Frame: 20 months vs. 21 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.
22. Change in daily communication performance [ Time Frame: 21 months vs. 22 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.
23. Change in daily communication performance [ Time Frame: 22 months vs. 23 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.
24. Change in daily communication performance [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 14 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Individuals with severe communication disabilities and minimal movement impairment.

Criteria

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

Contacts and Locations

Contacts

Contact: Katya Hill, PhD; 412-523-6424; khill@pitt.edu

Locations

United States, Pennsylvania

AAC Institute Clinic (ICAN Talk Clinic); Recruiting

Carnegie, Pennsylvania, United States, 15102

Contact: Shannon Carney 412-489-5527 scarney@aacinstitute.org

University of Pittsburgh, AAC Performance and Testing Laboratory; Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contact: Katya Hill, PhD 412-523-6424 khill@pitt.edu

Sponsors and Collaborators

University of Pittsburgh

National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

• Principal Investigator: Katya Hill, PhD; University of Pittsburgh

More Information

• Responsible Party: Katya Hill, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04026581
• Other Study ID Numbers: STUDY19010094; 90IFDV0002-01-00 ( Other Grant/Funding Number: NIDILRR )
• First Posted: July 19, 2019
• Last Update Posted: October 7, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
• Supporting Materials: 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.

• 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

Additional relevant MeSH terms:

Brain Injuries; Cerebral Palsy; Brain Injuries, Traumatic; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Speech Disorders; Brain Stem Infarctions; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Neurodegenerative Diseases; Neuromuscular Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Stroke; Vascular Diseases