Compatibility Between Brain-Computer Interface and High Efficiency Augmentative and Alternative Communication Systems: Commercial Readiness

Compatibility Between Brain-Computer Interface and High Efficiency Augmentative and Alternative Communication Systems: Commercial Readiness Brain-computer interfaces (BCIs) enable text production for people who cannot move but include only simple communication interfaces and are not widely used. Augmentative and alternative communication (AAC) systems are widely used and give efficient and precise communication, but require movement, preventing use by people with severe impairments, such as advanced amyotrophic lateral sclerosis or severe cerebral palsy. Phase I and Phase II STTR efforts created a prototype commercial-grade AAC-BCI peripheral for the Prentke Romich Company’s (PRC’s) extensive language application and communication system product line. In accordance with PAR-20-130, the SBIR/STTR Commercialization Readiness Pilot (CRP) Program for Technical Assistance and Late Stage Development, the overall objective of this application is to complete late- stage development of the AAC-BCI, optimize the design for long-term use by target users, finalize regulatory and reimbursement pathways, evaluate train-the-trainer resources, and conduct a small clinical trial of in-home product use to plan future, larger clinical trials. This object will be accomplished by the following specific aims: Aim 1: Optimize the AAC-BCI design with regard to long-term use with target user populations. Iterative cycles of laboratory testing and software development will optimize the AAC-BCI. Optimization will include an automatic standby mode which the user can independently exit when communication is desired. Aim 2: Optimize AAC-BCI design for regulatory and reimbursement considerations. Risk Analysis, laboratory testing, iterative engineering refinements and documentation will ensure that the AAC-BCI qualifies for medical device reimbursement by the Centers for Medicaid and Medicare Services (CMS), meets FDA Class II (Exempt) Medical Device requirements, and meets corresponding international regulations. Aim 3: Evaluate dosage and delivery of AAC-BCI training resources to achieve practitioner competence for clinical services. AAC-BCI users, support persons and interprofessional practitioners will evaluate training and support resources. PRC consultants and clinicians will participant in trainings that vary in dosage and types, evaluate their experience and satisfaction, and complete a competency task checklist, brief interview, and online survey. Aim 4: Clinical trial of in-home AAC-BCI use by people with specific target user characteristics. PRC consultants and clinicians from Aim 3 trainings will identify potential AAC-BCI users and support people, train them on in-home AAC-BCI set-up and communication and follow monthly to track use and satisfaction. The innovation of this work is merging BCI access into PRC’s high-efficiency AAC language production designs that match individual ability, need, and preference. The significance is the extension of quality-of-life communication with CMS reimbursement approval to those with the most severe physical impairments, providing an AAC-BCI from an established company with a clinical support network to provide services across the lifespan.