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出境医 / 临床实验 / Real World Testing of a Brain-Computer Interface
Real World Testing of a Brain-Computer Interface
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, 2022 |
| Estimated Study Completion Date : | August 31, 2023 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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.
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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.
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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.
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Outcome Measures
Primary Outcome 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 Outcome 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.
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 |
| 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 |
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| Original Primary Outcome Measures | Same as current | ||||||||||
| Change History | |||||||||||
| Current Secondary Outcome Measures |
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| 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 |
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| 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 |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||
| Recruitment Status | Recruiting | ||||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 14 Years and older (Child, Adult, Older Adult) | ||||||||||
| Accepts Healthy Volunteers | No | ||||||||||
| Contacts |
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| 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 ) |
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| Has Data Monitoring Committee | No | ||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Katya Hill, University of Pittsburgh | ||||||||||
| Study Sponsor | University of Pittsburgh | ||||||||||
| Collaborators | National Institute on Disability, Independent Living, and Rehabilitation Research | ||||||||||
| Investigators |
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| PRS Account | University of Pittsburgh | ||||||||||
| Verification Date | September 2020 | ||||||||||
