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

脑机接口与高效增强和替代通信系统之间的兼容性：商业准备情况

• 批准号: 10384113
• 负责人: KATYA J HILL
• 金额: $ 96.52万
• 依托单位: PRENTKE ROMICH COMPANY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10384113
• 关键词: Adopted; Algorithms; Amyotrophic Lateral Sclerosis; Augmentative and Alternative Communication; Calibration; Cerebral Palsy; Characteristics; Clinical; Clinical Competence; Clinical Services; Clinical Trials; Communication; Competence; Complex; Computer software; Consumption; Country; Custom; Data; Degenerative Disorder; Detection; Development; Device Designs; Documentation; Electroencephalography; Engineering; Ensure; European; Eye; Family member; Funding Mechanisms; Future; Goals; Hand; Head; Health; Home; Human Resources; Impairment; Individual; International; Interview; Laboratories; Language; Longevity; Maintenance; Medical Device; Methods; Mission; Monitor; Movement; Participant; Pathway interactions; Peripheral; Persons; Phase; Population; Production; Public Health; Qualifying; Quality of life; Readiness; Regulation; Resources; Risk; Safety; Services; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Societies; Support System; Surveys; System; Techniques; Testing; Text; Trainers Training; Training; Training Support; United States Centers for Medicare and Medicaid Services; United States National Institutes of Health; User-Computer Interface; Voice; Volition; Work; automated algorithm; base; brain computer interface; commercialization; design; disability; dosage; efficacy testing; experience; gaze; improved; innovation; online resource; preference; prevent; programs; prototype; satisfaction; screening; software development; support network; touchscreen; virtual

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.

大脑计算机界面和 高效率增强和替代通信系统：商业准备 脑部计算机界面（BCIS）为无法移动但仅包括简单的人提供文本生产 通信接口，不广泛使用。增强和替代通信（AAC）系统 被广泛使用并提供高效，精确的沟通，但需要移动，以防止人们使用 严重损害，例如晚期肌萎缩性侧索硬化症或严重的脑瘫。第一阶段和 第二阶段的STTR努力创建了一个原型商业级AAC-BCI的Prentke Romich 公司（PRC）广泛的语言应用和通信系统产品线。 根据Par-20-130 par-20-130，SBIR/STTR商业化准备飞行员（CRP）计划 技术援助和后期发展，本申请的总体目标是完成晚期 AAC-BCI的舞台开发，优化目标用户长期使用的设计，最终确定监管 以及报销途径，评估训练训练的资源并进行一项小型临床试验 产品用于计划未来，更大的临床试验。该对象将通过以下特定目的来完成： 目标1：关于与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循环将优化AAC-BCI。优化将 包括一个自动待机模式，当需要通信时，用户可以独立退出。 AIM 2：优化AAC-BCI设计，以进行调节和报销注意事项。 风险分析，实验室测试，迭代工程改进和文档将确保 AAC-BCI有资格获得医疗机构和医疗保险服务中心（CMS）的医疗设备报销 满足FDA II类（豁免）医疗设备要求，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从业者 临床服务的能力。 AAC-BCI用户，支持人员和专业专业的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各种剂量和类型的培训，评估 他们的经验和满意度，并完成了能力任务清单，简短面试和在线调查。 AIM 4：具有特定目标用户特征的人使用的家庭AAC-BCI使用的临床试验。 AIM 3培训的中国顾问和临床医生将确定潜在的AAC-BCI用户并支持人员， 在室内AAC-BCI设置和沟通上训练他们，并按月跟踪使用和满意度。 这项工作的创新是将BCI访问到中国的高效AAC语言制作中 设计与个人能力，需求和偏好相匹配的设计。意义是延长生活质量 与CMS偿还批准的批准，以提供最严重的身体障碍的人 来自一家拥有临床支持网络的成熟公司的AAC-BCI，可在整个生命周期内提供服务。