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About
The goal of this clinical trial is to evaluate the commercial readiness of an Augmentative and Alternative Communication Brain-Computer Interface (AAC-BCI) device for people with minimal movement who benefit from expressive communication technology. Our clinical trial focuses on up to 8 AAC-BCI users but involves a team of support participants with different roles: an industry partner's consultant, a speech language pathologist (SLP), and the user's in-home support person. Patient and team reported outcome measures data will be collected on usage, performance, reliability and comfort along with performance data of using the AAC-BCI device in the home.
Full description
Our clinical trial focuses on 8 Alternative Communication Brain-Computer Interface (AAC-BCI) users but involves a team of support participants with different roles: an industry partner's consultant, a speech language pathologist (SLP) and the user's in-home support person. The AAC-BCI user and support person will be recruited from the SLP's clinic and screened to confirm that the individuals meet the inclusion and exclusion criteria before enrollment. The investigators intend to recruit users with a perceived need for Brain-Computer Interface (BCI) access, ex: eye gaze access is deteriorating, unable to determine another access method. The investigators expect that our user participants will be in late-stage amyotrophic lateral sclerosis (ALS), diagnosed with a brainstem stroke, other degenerative neurologic disorder such as Kennedy disease, or have severe quadriplegic cerebral palsy. The support person will be screened to ensure they are comfortable with technology, learning innovative technology and are available to set-up the AAC-BCI daily at the user's request. The home must have internet. A total of 8 enrolled users means that the investigators will have up to 16 team members supported by a consultant. All clinical trial activity will occur in the home. Once consented and enrolled, the first training session with set-up and calibration will occur with the SLP and PRC consultant. The support person must be present. A second training session with a calibration check and use and training on electroencephalogram (EEG) and logfile data collection will occur within one week. The following baseline data will be collected by the consultant and SLP: 1) A functional rating scale; 2) copy spell task (15 minutes); 3) free spell task (15 minutes); National Aeronautics and Space Administration (NASA) Task Load Index (TLX).
The roles of the team members are as follows:
At the end of the 6-month study, participants will complete a Qualtrics survey to rate the overall commercial readiness of the AAC-BCI device along with rating the AAC-BCI device on satisfaction, performance, reliability, and comfort.
Enrollment
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Inclusion criteria
For augmentative and alternative communication, brain-computer interface (AAC-BCI) Users:
For Support Persons
For PRC Regional Consultants
For Clinicians:
Exclusion criteria
For Support Persons:
Unable to participate during the scheduled time periods
Can not attend the in-home training sessions
--Does not speak English
Does not know how to use the internet
For PRC Regional Consultants:
For Clinicians:
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Jane Huggins, PhD; Katharine J Hill, PhD
Data sourced from clinicaltrials.gov
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