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，脑机接口（BCI）一直被探索作为恢复通信的一种手段 闭锁综合征（LIS）是一种毁灭性的，往往是不可逆的神经系统疾病， 认知功能完好，但大脑几乎所有的运动输出都被中断，有效地切断了沟通 与外界的联系迄今为止，非侵入性BCI（例如EEG）具有不足的信号保真度和空间分辨率。 分辨率，而在手部运动皮层中使用微电极阵列的侵入性BCI已经提供了光标和 多关节机器人控制在受控设置，但一直难以学习，并需要经常 由于微电极-组织界面的不稳定性，重新训练解码模型。 我们的团队最近使用了高密度皮层电图（ECoG）记录（JHU和 Utrecht大学）和其他人用于各种不同上肢的实时检测和分类 动作和语音成分。ECoG具有足够的时空分辨率和信号质量， 解码上肢原生皮层表征的宽带高伽马（~60 - 200 Hz）响应 动作和言语。语音表示在空间上分布在几平方厘米上， 理想地适用于皮层电图（ECoG），但不适用于MEA。 在NEJM最近发表的一篇具有里程碑意义的论文（Vansteensel et al. 2016）中，拉姆齐博士在乌得勒支的团队证明了 LIS患者在家中使用完全植入式无线ECoG BCI，无需研究人员监督。 为了扩展这个4通道系统的功能，我们的团队提出了一项首次人体临床试验， 确定植入6个月的具有更多通道的ECoG BCI的安全性和有效性。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的建议"CortiCom系统"，它独特地结合了128通道高清- 带有经皮基座连接器和神经信号处理器（Blackrock）的ECoG阵列（PMT Corp 微系统）。在这个早期可行性试验中，我们的团队将追求以下目标/里程碑： 1.证明对基本BCI功能的有效和稳定控制（启动BCI、呼叫护理人员和BCI 菜单导航）。CortiCom将使用实时解码不同手指，手臂 关节、嘴部和面部肌肉，以控制关键的BCI功能，例如护理人员呼叫（3个月）， 和菜单导航-上/下/左/右，回车，后退/退出（6个命令）。 2.演示基于关键字的语音BCI的高效和稳定操作。CortiCom将使用低- 延迟检测和尝试语音（关键字）的分类以扩展通信。关键字 解码将使用分层混合模型来基于关键字的独特空间- 人口活动的时间特征关键字命令词汇表，基于通信值和 在试验期间，将从6个（3个月）扩大到20个或更多的关键词。