Real World Testing of a Brain-Computer Interface

December 5, 2023 updated by: Katya Hill, University of Pittsburgh

Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Katya Hill, PhD
  • Phone Number: 412-523-6424
  • Email: khill@pitt.edu

Study Locations

  • United States
    • Pennsylvania
      • Carnegie, Pennsylvania, United States, 15102
        • AAC Institute Clinic (ICAN Talk Clinic)
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh, AAC Performance and Testing Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with severe communication disabilities and minimal movement impairment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline vs. 1 month
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.
1 month vs. 2 months
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.
2 months vs. 3 months
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.
3 months vs. 4 months
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.
4 months vs. 5 months
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.
5 months vs. 6 months
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.
6 months vs. 7 months
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.
7 months vs. 8 months
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.
8 months vs. 9 months
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.
9 months vs. 10 months
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.
10 months vs. 11 months
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.
11 months vs. 12 months
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.
12 months vs. 13 months
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.
13 months vs. 14 months
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.
14 months vs. 15 months
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.
15 months vs. 16 months
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.
16 months vs. 17 months
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.
17 months vs. 18 months
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.
18 months vs. 19 months
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.
19 months vs. 20 months
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.
20 months vs. 21 months
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.
21 months vs. 22 months
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.
22 months vs. 23 months
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.
23 months vs. 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline vs. 1 month
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.
1 month vs. 2 months
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.
2 months vs. 3 months
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.
3 months vs. 4 months
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.
4 months vs. 5 months
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.
5 months vs. 6 months
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.
6 months vs. 7 months
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.
7 months vs. 8 months
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.
8 months vs. 9 months
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.
9 months vs. 10 months
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.
10 months vs. 11 months
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.
11 months vs. 12 months
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.
12 months vs. 13 months
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.
13 months vs. 14 months
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.
14 months vs. 15 months
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.
15 months vs. 16 months
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.
16 months vs. 17 months
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.
17 months vs. 18 months
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.
18 months vs. 19 months
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.
19 months vs. 20 months
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.
20 months vs. 21 months
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.
21 months vs. 22 months
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.
22 months vs. 23 months
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.
23 months vs. 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katya Hill, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY19010094
  • 90IFDV0002-01-00 (Other Grant/Funding Number: NIDILRR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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