Investigation of the Cortical Communication (CORTICOM) System

皮质通讯 (CORTICOM) 系统的研究

• 批准号: 10256610
• 负责人: NATHAN E CRONE
• 金额: $ 230.97万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10256610
• 关键词: Academic Medical Centers; Amendment; Amyotrophic Lateral Sclerosis; Anatomy; Articulators; Back; Blinking; Brain; Brain Stem; Caliber; Caregivers; Classification; Clinical Trials; Cognition; Communication; Complement; Complex; Detection; Devices; Electrocorticogram; Electrodes; Electroencephalography; Enrollment; Epilepsy; Eye; Eye Movements; Face; Fatigue; Fingers; Freedom; Frequencies; Gestures; Hand; Home; Home environment; Hybrids; Implant; Institutional Review Boards; Interruption; Intuition; Investigation; Joints; Learning; Left; Lesion; Locked-In Syndrome; Love; Microelectrodes; Modeling; Motor; Motor Cortex; Motor output; Movement; Muscle; Neurodegenerative Disorders; Neurologic; Neurons; Oral cavity; Paper; Patients; Population; Prosthesis; Reporting; Research Personnel; Resolution; Risk; Safety; Secure; Self-Help Devices; Signal Transduction; Speech; Stroke; Supervision; Surface; System; Testing; Time; Tissues; Training; Universities; Upper limb movement; Vocabulary; Wireless Technology; arm; base; brain computer interface; cognitive load; density; design; disability; feasibility testing; feasibility trial; first-in-human; microsystems; motor impairment; neuroregulation; neurotransmission; operation; phrases; portability; prosthesis control; relating to nervous system; response; robot control; safety testing; success; temporal measurement; tumor

For many years brain-computer interfaces (BCI's) have been explored as a means of restoring communication to patients with Locked-In Syndrome (LIS), a devastating and often irreversible neurological condition in which cognition is intact but nearly all motor output from the brain is interrupted, effectively cutting off communication with the outside world. To date non-invasive BCI's (e.g. EEG) have had inadequate signal fidelity and spatial resolution, while invasive BCI's using microelectrode arrays in hand motor cortex have delivered cursor and multi-joint robotic control in controlled settings, but have been difficult to learn and have required frequent retraining of decoding models, due to instabilities in the microelectrode-tissue interface. High-density electrocorticographic (ECoG) recordings have been recently used by our team (JHU and University of Utrecht) and by others for real-time detection and classification of a variety of different upper limb movements and speech components. ECoG has sufficient spatial-temporal resolution and signal quality to decode the broadband high-gamma (~60-200 Hz) responses of native cortical representations for upper limb movements and speech. Speech representations are spatially distributed over several square centimeters, ideally suited for electrocorticography (ECoG), but impractical for MEA's. In a recent landmark paper in NEJM (Vansteensel et al. 2016) Dr. Ramsey's team in Utrecht demonstrated home use of a fully implantable wireless ECoG BCI by a patient with LIS, without supervision by researchers. To expand on the capabilities of this 4-channel system, our team proposes a first-in-human clinical trial to establish the safety and efficacy of an ECoG BCI with far more channels, implanted for 6 months. Based on the long-term safety and signal quality of ECoG demonstrated in neuromodulation for epilepsy (Neuropace RNS), we have an IDE for the proposed “CortiCom System”, which uniquely combines a 128-channel HD- ECoG array (PMT Corp) with a transcutaneous pedestal connector and neural signal processor (Blackrock Microsystems). In this early feasibility trial, our team will pursue the following Aims/Milestones: 1. Demonstrate efficient and stable control of essential BCI functions (initiate BCI, call caregiver, and BCI menu navigation). CortiCom will use real-time decoding of attempted movements of different fingers, arm joints, and mouth and face muscles to control the critical BCI functions, e.g. caregiver calling (by 3 months), and menu navigation--Up/Down/Left/Right, Enter, and Back/Escape (6 commands). 2. Demonstrate efficient and stable operation of a keyword-based speech BCI. CortiCom will use low- latency detection and classification of attempted speech (keywords) to expand communication. Keyword decoding will use a hierarchical hybrid model to detect and classify keywords based on their unique spatial- temporal signatures of population activity. Keyword command vocabulary, based on communication value and ease of classification, will expand from 6 (by 3 months) to 20 or more keywords during the trial.

多年来，人们一直在探索脑机接口(BCI)作为一种恢复通信的手段 对于闭锁综合征(LIS)患者来说，这是一种毁灭性的且通常是不可逆转的神经状况，在这种情况下 认知是完好无损的，但大脑几乎所有的运动输出都被中断，有效地切断了沟通 与外部世界打交道。到目前为止，非侵入性脑机接口(如脑电)的信号保真度和空间分布都不够理想 分辨率，而在手运动皮质使用微电极阵列的侵入性BCI将光标和 在受控环境下的多关节机器人控制，但很难学习，需要经常使用 由于微电极-组织界面的不稳定，解码模型的重新训练。 我们的团队最近使用了高密度皮层脑电(ECoG)记录(JHU和 乌得勒支大学)和其他人用于实时检测和分类各种不同的上肢 动作和语音成分。ECOG具有足够的时空分辨率和信号质量 解码上肢自然皮质代表的宽带高伽马(~60-200赫兹)反应 动作和语言。语音表示在空间上分布在几平方厘米上， 非常适合于皮层脑电图术(ECoG)，但不适用于MEA。 在最近发表在《新英格兰医学杂志》上的一篇里程碑式的论文中(Vansteensel等人，2016)拉姆齐博士在乌得勒支的团队展示了 一名LIS患者在没有研究人员监督的情况下，在家中使用完全可植入的ECoG脑机接口。 为了扩展这个4通道系统的能力，我们的团队提出了一项首个人类临床试验，以 建立具有更多通道的ECoG BCI的安全性和有效性，植入6个月。基于 ECoG在癫痫神经调节中的长期安全性和信号质量(NeuroPace) RNS)，我们有一个IDE，为建议的“CortiCom系统”，它独特地结合了128个通道的高清- 带有经皮基座连接器和神经信号处理器的ECOG阵列(PMT公司)(BlackRock 微系统)。在这一早期可行性试验中，我们的团队将实现以下目标/里程碑： 1.展示对基本BCI功能的有效和稳定控制(启动BCI、呼叫护理员和BCI 菜单导航)。CortiCom将使用实时解码不同手指、手臂的尝试动作 关节，以及口腔和面部肌肉，以控制关键的BCI功能，例如护理员呼叫(3个月)， 和菜单导航--Up/Down/Left/Right、Enter和Back/Escape(6个命令)。 2.演示了基于关键字的语音BCI的高效稳定运行。CortiCom将使用LOW- 对尝试的语音(关键字)进行延迟检测和分类以扩展通信。关键字 解码将使用分层混合模型来检测关键字并根据其唯一的空间- 人口活动的时间特征。关键字命令词汇表，基于通信价值和 易于分类，将在试验期间从6个(3个月)扩展到20个或更多关键字。