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

脑控制通信指标：肌萎缩侧索硬化症通信脑机接口临床结果评估的全面综述

• 批准号: 10848139
• 负责人: Spencer Kellis
• 金额: $ 19.98万
• 依托单位: BLACKROCK MICROSYSTEMS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10848139
• 关键词: Metrics; Brain; Controlled; Communication; comprehensive

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.

项目总结/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。病人可能活好几年 在症状发作后，导致完全丧失书面和口头交流， 降低生活质量，增加护理人员负担，并对延长生命的护理造成重大障碍， ALS研究工作。通信脑机接口（cBCI）提供了一个独特的机会， 为那些由于ALS或其他原因而严重瘫痪的人提供无运动交流。以前的工作与 Blackrock Neurotech cBCI技术已经开发出控制键盘、解码笔迹、恢复 言语，并恢复锁定ALS患者的言语交流。与我们的发展相结合 突破性的cBCI技术，我们希望引领市场的全面发展 cBCI如何影响ALS患者以及未来的进步如何更好地改善患者生活的知识库 那些患有这种不可逆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），以获取（1）ALS患者及其护理人员的需求和价值观，以及 医疗保健提供者与沟通和cBCI相关，（2）患者对cBCI的看法，（3）能力 和使用cBCI的通信的有效性，（4）cBCI对患者的医疗保健和生活质量的影响， 护理人员，和（5）cBCI在ALS人群中的财务和健康经济影响。鉴于相对 cBCI作为ALS患者的一种选择的新奇以及cBCI技术内部和之间的变化， 迫切需要更好地了解cBCI如何进行临床评估，并建立未来的框架。 ALS患者cBCI的COA开发。我们的目标是发展一个深入和广泛的 了解（1）当前围绕cBCI的临床和科学前景，（2）评估其 影响和有效性，（3）当前COA的优势和劣势，（4）患者需求及其感知 评估未来COA发展的领域。UH 2开发将包括一个 全面的文献综述和对关键意见领袖的一系列采访，以建立 知识以及与cBCI和ALS患者相关的当前COA景观的专家观点 人口UH 3的开发将与约翰霍普金斯大学合作进行 国家康复中心和犹他州大学，将包括一系列的病人和护理人员， 焦点小组深入了解与沟通和cBCI相关的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的现状，并确定了未来发展COA的明确途径，以帮助 cBCI的临床应用和评估，以改善晚期ALS患者的生活。