Brain-computer Interface Commercial Readiness
NCT Number: NCT06521736
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-Verbal Communication|Degenerative Neurologic Disease
Interventions: DEVICE: AAC-BCI device
Sponsor: Katharine Katya Joan Hill
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)|University of Michigan|PRC
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-05-31
Locations: University of Pittsburgh, Pittsburgh, Pennsylvania, 15260, United States

Summary:
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.

Primary Outcome Measures: Commercial readiness of augmentative and alternative communication brain-computer interface (AAC-BCI) system., Stakeholder participants agree "yes" that the Alternative Communication Brain-Computer Interface (AAC-BCI) system is ready for product release with an average combined agreement of 70% on a binary yes/no scale., 6 months
Secondary Outcome Measures: Alternative Communication Brain-Computer Interface (AAC-BCI) system user-satisfaction, Participants rate degree of satisfaction associated with use of the Alternative Communication Brain-Computer Interface (AAC-BCI) system for communication using a five-point Likert Scale where 1= Very Dissatisfied, 2= Dissatisfied, 3= Neither Satisfied or Dissatisfied, 4= Satisfied, and 5= Very Satisfied; 1-3 is a negative outcome, and 4-5 are a positive outcome., 6 months|Alternative Communication Brain-Computer Interface (AAC-BCI) system performance, Participants rate degree of satisfaction with the overall performance of the Alternative Communication Brain-Computer Interface (AAC-BCI) system during communication using a five-point Likert Scale where 1= Very Dissatisfied, 2= Dissatisfied, 3= Neither Satisfied or Dissatisfied, 4= Satisfied, and 5= Very Satisfied; 1-3 is a negative outcome, and 4-5 are a positive outcome., 6 months|Alternative Communication Brain-Computer Interface (AAC-BCI) system reliability, Participants rate degree of satisfaction with the overall reliability of the Alternative Communication Brain-Computer Interface (AAC-BCI) system features and functions during daily use using a five-point Likert Scale where 1= Very Dissatisfied, 2= Dissatisfied, 3= Neither Satisfied or Dissatisfied, 4= Satisfied, and 5= Very Satisfied; 1-3 is a negative outcome, and 4-5 are a positive outcome., 6 months|Alternative Communication Brain-Computer Interface (AAC-BCI) system comfort, Participant rate degree of satisfaction with the overall comfort of using the Alternative Communication Brain-Computer Interface (AAC-BCI) system during daily use using a five-point Likert Scale where 1= Very Dissatisfied, 2= Dissatisfied, 3= Neither Satisfied or Dissatisfied, 4= Satisfied, and 5= Very Satisfied; 1-3 is a negative outcome, and 4-5 are a positive outcome., 6 months