Real World Testing of a Brain-Computer Interface

Overview

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.

Full Title of Study: “Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2023

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.

Interventions

  • 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.

Arms, Groups and 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pittsburgh
  • Collaborator
    • National Institute on Disability, Independent Living, and Rehabilitation Research
  • Provider of Information About this Clinical Study
    • Principal Investigator: Katya Hill, Associate Professor – University of Pittsburgh
  • Overall Official(s)
    • Katya Hill, PhD, Principal Investigator, University of Pittsburgh

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