Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for individuals with neurodegenerative diseases or nervous system disorders who have limited movement and could benefit from technology that helps them communicate. Participants will use an AAC-BCI device at home, supported by a team including a consultant, speech therapist, and in-home support person.Inclusion Criteria
I am 18 years old or older.
For augmentative and alternative communication, brain-computer interface (AAC-BCI) Users:
Natural speech does not meet daily communication needs requiring the use of a speech generating device
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Exclusion Criteria
For AAC-BCI Users:
Does not own or use a speech generating device
I cannot participate in the study during the scheduled times.
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Participant Groups
The study tests the readiness of an AAC-BCI device for market release by assessing its usage, performance, reliability, and comfort when used by patients in their homes. It involves both patient feedback and objective performance data collection.
1Treatment groups
Experimental Treatment
Group I: Testing commercial readiness of an AAC-BCI deviceExperimental Treatment1 Intervention
Participants with severe movement disabilities will use the augmentative and alternative communication, brain-computer interface (AAC-BCI) device at least 10 hours a week in their homes receiving supported from a caregiver, speech language pathologist and consultant and rate the intervention on user satisfaction, performance, reliability, comfort and overall readiness for commercialization.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PittsburghPittsburgh, PA
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Who Is Running the Clinical Trial?
Katharine Katya Joan HillLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
PRCCollaborator
University of MichiganCollaborator