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Real World Testing of a Brain-Computer Interface

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ClinicalTrials.gov Identifier: NCT04026581
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Katya Hill, 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.

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.

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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, 2022
Estimated Study Completion Date : August 31, 2023


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026581


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

Locations
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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
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Principal Investigator: Katya Hill, PhD University of Pittsburgh

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Responsible Party: Katya Hill, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04026581     History of Changes
Other Study ID Numbers: STUDY19010094
90IFDV0002-01-00 ( Other Grant/Funding Number: NIDILRR )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
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.

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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:
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Brain Injuries
Brain Injuries, Traumatic
Cerebral Palsy
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Speech Disorders
Brain Stem Infarctions
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
Signs and Symptoms
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Stroke
Vascular Diseases