Metrics for Brain Controlled Communication: A comprehensive review of clinical outcome assessments for communication brain computer interfaces in amyotrophic lateral sclerosis

项目摘要/摘要 美国目前约有25,000人患有肌萎缩侧索硬化症(ALS)， 最终致命的神经退行性疾病，逐渐影响运动功能。患者可能会存活数年 在出现导致完全丧失书面和口头交流的症状后，这会显著地 降低生活质量，增加照顾者负担，并对延长护理和 渐冻症的研究努力。通信脑机接口(CBCI)为完全 由于肌萎缩侧索硬化症或其他原因导致严重瘫痪的人可以自由交流。之前的工作与 贝莱德神经科技CBCI技术已经开发出控制键盘、破译笔迹、恢复 言语，并恢复锁定的ALS患者的言语交流。与我们的开发相结合 开创性的CBCI技术，我们希望引领市场全面发展 关于cBCI如何影响ALS患者以及未来的进步如何更好地改善ALS患者生活的知识库 那些患有这种不可逆转的致命疾病的人。我们的长期目标是建立和验证标准化的临床 结果评估(COA)，以捕捉(1)ALS患者、他们的照顾者和 与通信和cBCI相关的医疗保健提供者，(2)患者对cBCI的看法，(3)能力 和使用cBCI的沟通效果，(4)cBCI对患者的医疗保健和生活质量的影响 以及(5)在ALS人群中cBCI的财务和卫生经济影响。给出了相对的 CBCI作为ALS患者的一种选择的新颖性以及CBCI技术内部和跨CBCI技术的差异，有一个 迫切需要更好地了解cBCI是如何在临床上评估的，并为未来建立框架 肌萎缩侧索硬化症患者cBCI的COA研究进展。我们的目标是发展深度和广度的 了解(1)当前临床和科学环境对脑出血的影响，(2)对其评估 影响和疗效，(3)当前COA的优势和劣势，(4)患者的需求和他们的看法 (5)评估未来COA发展的领域。UH2的发展将包括一个 全面的文献回顾和对主要意见领袖的一系列采访，以建立 关于当前与cBCI和ALS患者相关的COA环境的知识和专家观点 人口。UH3的开发将与约翰·霍普金斯大学、兰乔·洛斯·阿米戈斯合作进行 国家康复中心和犹他大学，将由一系列患者和照顾者组成 焦点小组，深入了解与沟通和CBCI相关的具有临床意义的概念和终点 技术。在这个项目结束时，我们的期望是，我们将全面评估 CBCI的COA现状，并确定了COA未来发展的明确路径，以帮助 在临床应用和评估cBCI以提高晚期ALS患者的生活质量。

PROJECT SUMMARY/ABSTRACT Approximately 25,000 individuals in the US are currently living with amyotrophic lateral sclerosis (ALS), an ultimately fatal neurodegenerative disease that progressively impacts motor function. Patients may live for years after the onset of symptoms that result in complete loss of written and verbal communication, which drastically decreases quality of life, increases caregiver burden, and creates a significant barrier to life extending care and ALS research efforts. Communication brain computer interfaces (cBCIs) offer a unique opportunity for completely movement-free communication for those with severe paralysis due to ALS or other causes. Prior work with Blackrock Neurotech cBCI technology has developed methods to control keyboards, decode handwriting, restore speech, and restore verbal communication in locked-in ALS patients. In conjunction with development of our ground-breaking cBCI technologies, we hope to lead the market in the development of a comprehensive knowledgebase of how cBCIs affect ALS patients and how future advancements can better improve the lives of those with this irreversible, fatal condition. Our long-term goal is to establish and validate standardized clinical outcome assessments (COAs) to capture (1) the needs and values of ALS patients, their caregivers, and healthcare providers as they relate to communication and cBCIs, (2) patient perceptions of cBCIs, (3) capacity and efficacy of communication using cBCIs, (4) healthcare and quality of life impacts of cBCIs on patients and caregivers, and (5) financial and health economic impacts of cBCIs in the ALS population. Given the relative novelty of cBCIs as an option for ALS patients and the variation within and across cBCI technologies, there is a critical need to better understand how cBCIs are clinically assessed and to establish a framework for future development of COAs for cBCIs in patients with ALS. Our objective is to develop a deep and wide-ranging understanding of (1) the current clinical and scientific landscape surrounding cBCIs, (2) the assessment of their impacts and efficacy, (3) the strengths and weaknesses of current COAs, (4) patient needs and their perceptions of cBCIs, and (5) to evaluate areas for future COA development. UH2 development will comprise a comprehensive literature review and a series of interviews with key opinion leaders to establish a base of knowledge as well as expert perspectives on the current COA landscape related to cBCIs and the ALS patient population. UH3 development will occur in collaboration with Johns Hopkins University, Rancho Los Amigos National Rehabilitation Center, and the University of Utah and will consist of a series of patient and caregiver focus groups to gain insight into clinically meaningful concepts and endpoints related to communication and cBCI technologies. At the conclusion of this project, our expectation is that we will have comprehensively assessed the current landscape of COAs for cBCIs and identified a clear path toward future development of COAs to aid in clinical application and assessment of cBCIs to enhance the lives of those with advanced ALS.