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

脑机接口与计算机接口的兼容性 高效增强型和替代通信系统：商业准备 脑机接口(BCI)使不能移动但仅包括简单文本的人能够产生文本 通信接口，并未得到广泛应用。增强和替代通信(AAC)系统 被广泛使用，并提供高效和准确的交流，但需要移动，防止被人使用 有严重损伤，如晚期肌萎缩侧索硬化症或严重脑瘫。第一阶段及 第二阶段STTR工作为Prentke Romich创建了一个商业级AAC-BCI外围设备原型 公司(中国)广泛的语言应用和交流系统产品线。 根据PAR-20-130，SBIR/STTR商业化准备试点(CRP)计划 技术援助和后期开发，本申请的总体目标是完成后期- AAC-BCI的阶段性开发，优化设计以供目标用户长期使用，最终确定法规 和报销路径，评估培训员培训资源，并进行家庭内的小型临床试验 使用产品来规划未来更大规模的临床试验。这一目标将通过以下具体目标来实现： 目标1：针对目标用户群体的长期使用，优化AAC-BCI设计。 实验室测试和软件开发的迭代周期将优化AAC-BCI。优化将 包括当需要通信时用户可以独立退出的自动待机模式。 目标2：出于监管和报销方面的考虑，优化AAC-BCI设计。 风险分析、实验室测试、迭代工程改进和文档将确保 AAC-BCI有资格获得医疗补助和医疗保险服务中心(CMS)的医疗器械报销， 符合FDA第二类(豁免)医疗器械要求，并符合相应的国际法规。 目标3：评估AAC-BCI培训资源的剂量和交付，以实现实践者 临床服务能力。 AAC-BCI用户、支持人员和跨专业从业人员将评估培训和支持 资源。中国顾问和临床医生将参加不同剂量和类型的培训，评估 他们的经历和满意度，并完成能力任务核对表、简短访谈和在线调查。 目的4：针对具有特定目标用户特征的人群进行家庭AAC-BCI使用的临床试验。 来自AIM 3培训的中国顾问和临床医生将确定潜在的AAC-BCI用户和支持人员， 对他们进行家庭AAC-BCI设置和沟通方面的培训，并每月跟踪跟踪使用情况和满意度。 这项工作的创新之处在于将BCI Access融入到中华人民共和国的高效AAC语言生产中 符合个人能力、需求和偏好的设计。其意义在于生活质量的延伸 与CMS报销批准沟通，为那些身体残疾最严重的人提供 AAC-BCI来自一家拥有临床支持网络的成熟公司，可在整个生命周期内提供服务。

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.