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| ID | Type | Description | Link |
|---|---|---|---|
| 90IFDV0002-01-00 | Other Grant/Funding Number | NIDILRR |
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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Speech generating device (SGD) evaluation including BCI access | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in daily communication performance | 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| User satisfaction of speech generating device (SGD) for daily communication | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with severe communication disabilities and minimal movement impairment.
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| Name | Affiliation | Role |
|---|---|---|
| Katya Hill, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AAC Institute Clinic (ICAN Talk Clinic) | Carnegie | Pennsylvania | 15102 | United States | ||
| University of Pittsburgh, AAC Performance and Testing Laboratory |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee.
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D020526 | Brain Stem Infarctions |
| D002547 | Cerebral Palsy |
| D000070642 | Brain Injuries, Traumatic |
| D013064 | Speech Disorders |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Training and treatment | Behavioral | 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. |
|
| Change in daily communication performance |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome. | 23 months vs. 24 months |
| Pittsburgh |
| Pennsylvania |
| 15260 |
| United States |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001925 | Brain Damage, Chronic |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |