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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 : September 9, 2020
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Katya Hill, University of Pittsburgh

Tracking Information
First Submitted Date July 17, 2019
First Posted Date July 19, 2019
Last Update Posted Date September 9, 2020
Actual Study Start Date June 5, 2019
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real World Testing of a Brain-Computer Interface
Official Title Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals with severe communication disabilities and minimal movement impairment.
Condition
  • Amyotrophic Lateral Sclerosis
  • Brain Stem Stroke
  • Cerebral Palsy
  • Traumatic Brain Injury
  • Speech Disorders
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • 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.
    Intervention: Behavioral: Speech generating device (SGD) evaluation including BCI access
  • 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.
    Intervention: Behavioral: Training and treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 17, 2019)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2023
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Katya Hill, PhD 412-523-6424 khill@pitt.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04026581
Other Study ID Numbers STUDY19010094
90IFDV0002-01-00 ( Other Grant/Funding Number: NIDILRR )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
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.
Responsible Party Katya Hill, University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
Principal Investigator: Katya Hill, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date September 2020