Clinical trial NCT04026581: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Brain Stem Stroke
Cerebral Palsy
Traumatic Brain Injury
Speech Disorders
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2019-07-19
Enrollment: 19
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with severe communication disabilities and minimal movement impairment.

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.

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

Primary outcomes:
measure: Change in daily communication performance
timeFrame: Baseline vs. 1 month
measure: Change in daily communication performance
timeFrame: 1 month vs. 2 months
measure: Change in daily communication performance
timeFrame: 2 months vs. 3 months
measure: Change in daily communication performance
timeFrame: 3 months vs. 4 months
measure: Change in daily communication performance
timeFrame: 4 months vs. 5 months
measure: Change in daily communication performance
timeFrame: 5 months vs. 6 months
measure: Change in daily communication performance
timeFrame: 6 months vs. 7 months
measure: Change in daily communication performance
timeFrame: 7 months vs. 8 months
measure: Change in daily communication performance
timeFrame: 8 months vs. 9 months
measure: Change in daily communication performance
timeFrame: 9 months vs. 10 months
measure: Change in daily communication performance
timeFrame: 10 months vs. 11 months
measure: Change in daily communication performance
timeFrame: 11 months vs. 12 months
measure: Change in daily communication performance
timeFrame: 12 months vs. 13 months
measure: Change in daily communication performance
timeFrame: 13 months vs. 14 months
measure: Change in daily communication performance
timeFrame: 14 months vs. 15 months
measure: Change in daily communication performance
timeFrame: 15 months vs. 16 months
measure: Change in daily communication performance
timeFrame: 16 months vs. 17 months
measure: Change in daily communication performance
timeFrame: 17 months vs. 18 months
measure: Change in daily communication performance
timeFrame: 18 months vs. 19 months
measure: Change in daily communication performance
timeFrame: 19 months vs. 20 months
measure: Change in daily communication performance
timeFrame: 20 months vs. 21 months
measure: Change in daily communication performance
timeFrame: 21 months vs. 22 months
measure: Change in daily communication performance
timeFrame: 22 months vs. 23 months
measure: Change in daily communication performance
timeFrame: 23 months vs. 24 months
Secondary outcomes:
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: Baseline vs. 1 month
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 1 month vs. 2 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 2 months vs. 3 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 3 months vs. 4 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 4 months vs. 5 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 5 months vs. 6 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 6 months vs. 7 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 7 months vs. 8 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 8 months vs. 9 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 9 months vs. 10 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 10 months vs. 11 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 11 months vs. 12 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 12 months vs. 13 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 13 months vs. 14 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 14 months vs. 15 months
measure: User satisfaction of speech generating device (SGD) or daily communication
timeFrame: 15 months vs. 16 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 16 months vs. 17 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 17 months vs. 18 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 18 months vs. 19 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 19 months vs. 20 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 20 months vs. 21 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 21 months vs. 22 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 22 months vs. 23 months
measure: User satisfaction of speech generating device (SGD) for daily communication
timeFrame: 23 months vs. 24 months
Other outcomes:
Locations:
city: Carnegie
country: United States
facility: AAC Institute Clinic (ICAN Talk Clinic)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh, AAC Performance and Testing Laboratory
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Katya Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References: