Translational refinement of adaptive communication system for locked-in patients

描述（由申请人提供）：脑机接口（BCI）技术的普及为闭锁患者提供了成功沟通的潜在途径。大多数BCI系统要么涉及从一组同时呈现的刺激中进行选择，这需要对界面进行广泛的控制；或者使用二元刺激选择机制，由于缓慢的意图检测或固定的（与上下文无关的）刺激顺序而无法实现高通信速率。我们提出了一个新的界面，使用二进制选择的文本输入，通过快速串行可视化呈现自然语言组件。由获得性神经系统疾病（肌萎缩性侧索硬化症、脑干中风、帕金森病、多发性硬化症、脊髓损伤）和神经发育障碍（脑瘫、肌肉萎缩症）导致的严重言语和身体障碍（SSPI）个体推动了拟议的研究。四个实验室组成了这个转化研究项目的联盟：基础研究（Erdogmus，工程学；Roark，计算机科学和自然语言处理）和临床研究（Oken，神经病学/神经生理学；Fried-Oken，增强沟通/神经源性沟通障碍）。我们的目标是(1)开发一种创新的基于脑电图的脑机接口，以更少的错误和更高的满意度为目标SSPI人群实现更高的通信速率；(2)根据健康受试者和已上市AAC系统的专家LIS用户的用户反馈，在实验室对系统进行迭代完善；(3)在SSPI患者的自然临床环境中评估该系统的性能。创新的BCI是RSVP键盘，具有三个基本特征：(1)语言成分的快速串行视觉呈现（RSVP），从字母到单词再到短语；(2)采用多通道脑电图（EEG）和/或其他合适的响应机制的检测机制，该机制可以可靠地指示用户的二元意图，并根据用户的个性化神经生理数据进行调整；(3)开放词汇自然语言模型，具有准确预测即将到来的文本的能力。理论框架建立在坚实的贝叶斯基础之上；临床可用性是基于世卫组织ICF（世卫组织，2001年）和参与的补充和替代沟通（AAC）模型。在临床实验室和自然环境中，将对健全的受试者和SSPI患者进行严格的实验审查。对36名健康受试者采用假设驱动的交叉设计，对40名SSPI患者采用交替治疗随机化设计，获得不同迭代RSVP键盘的学习率、信息生成速度、错误率和用户满意度。在自然环境中使用新系统的LIS患者的运动、认知和语言技能的描述将为临床指南和功能装置的适应提供信息，从而更好地为患有SSPI的儿童和成人提供个性化治疗。拟议的转化研究的合作性质有望为脑机接口开发和临床AAC应用产生新的知识。

DESCRIPTION (provided by applicant): The proliferation of brain-computer interface (BCI) technology promises locked-in patients potential ways to communicate successfully. Most BCI systems either involve selection from among a set of simultaneously presented stimuli, requiring extensive control of the interface; or use binary stimulus selection mechanisms that fail to achieve high communication rates because of slow intent detection or a fixed (context independent) ordering of stimuli. We propose a new interface using binary selection of text input via rapid serial visual presentation of natural language components. Individuals with severe speech and physical impairments (SSPI) resulting from acquired neurological disorders (amyotrophic lateral sclerosis, brainstem stroke, Parkinson's disease, multiple sclerosis, spinal cord injury) and neurodevelopmental disorders (cerebral palsy, muscular dystrophy) drive the proposed research. Four laboratories form an alliance for this translational research project: basic research (Erdogmus, engineering; Roark, computer science and natural language processing), and clinical research (Oken, neurology/neurophysiology; Fried-Oken, augmentative communication/neurogenic communication disorders). Our aims are (1) to develop an innovative EEG-based BCI that achieves increased communication rates with fewer errors and greater satisfaction for the target SSPI populations; (2) to iteratively refine the system in the laboratory with user feedback from healthy subjects and expert LIS users of marketed AAC systems; (3) to evaluate the performance of the system within the natural clinical settings of SSPI patients. The innovative BCI is the RSVP Keyboard with three essential features: (1) rapid serial visual presentation (RSVP) of linguistic components ranging from letters to words to phrases; (2) a detection mechanism that employs multichannel electroencephalography (EEG) and/or other suitable response mechanisms that can reliably indicate the binary intent of the user and adapt based on individualized neurophysiologic data of the user; and (3) an open-vocabulary natural language model with a capability for accurate predictions of upcoming text. Theoretical framework is based on a solid Bayesian foundation; clinical usability is based on the WHO ICF (WHO, 2001) and an Augmentative and Alternative Communication (AAC) model of participation. Rigorous experimental scrutiny in both clinical laboratory and natural settings will be obtained with able-bodied subjects and SSPI patients. Measures of learning rate, speed of message production, error rate and user satisfaction for different iterations of the RSVP keyboard will be obtained using an hypothesis-driven crossover design for 36 healthy subjects, and alternating treatment randomization design for 40 patients with SSPI. Descriptions of the motor, cognitive, and language skills of LIS patients using the novel system in their natural environments will inform clinical guidelines and functional device adaptations to better individualize treatment for children and adults with SSPI. The collaborative nature of the proposed translational research is expected to yield new knowledge for both BCI development and clinical AAC use. Relevance: The populations of patients with locked-in syndrome are increasing as medical technologies advance and successfully support life. These individuals with limited to no movement could potentially contribute to their medical decision making, informed consent, and daily care giving if they had faster, more reliable means to interface with communication systems. The RSVP keyboard and proposed language models are innovative technological discoveries that are being applied to clinical augmentative communication tools so that patients and their families can participate in daily activities and advocate for improvements in standard clinical care. The proposed project stresses the translation of basic computer science into clinical care, supporting the proposed NIH Roadmap and public health initiatives.