DIrectional and SCalable (DISC) Microelectrode Array for Speech Decoding

用于语音解码的定向和可扩展 (DISC) 微电极阵列

• 批准号: 10513043
• 负责人: JOHN P SEYMOUR
• 金额: $ 159.87万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10513043
• 关键词: Acute; Address; Animals; Aphasia; Area; Augmentative and Alternative Communication; Brain; Brain region; Broca Aphasia; Classification; Clinical; Communities; Craniotomy; Cues; Data; Development; Devices; Diagnostic; Dimensions; Dysarthria; Electrocorticogram; Electrodes; Electroencephalography; Enrollment; Epilepsy; Excision; Feasibility Studies; Functional disorder; Future; Goals; Human; Hybrids; Immunity; Implant; Industry; Information Networks; Institutional Review Boards; Intractable Epilepsy; Language; Language Therapy; Legal patent; Locked-In Syndrome; Longevity; Machine Learning; Mechanics; Methods; Microelectrodes; Modeling; Modification; Monitor; Neurobiology; Neurosciences; Noise; Observational Study; Operative Surgical Procedures; Patients; Performance; Persons; Physics; Positioning Attribute; Predictive Factor; Production; Radial; Reporting; Research Personnel; Resolution; Robotics; Rodent; Safety; Seizures; Shapes; Sheep; Signal Transduction; Source; Speech; Speech Therapy; Surface; Surgeon; System; Technology; Testing; Time; Tissues; Trephine hole; Utah; Validation; Vibrissae; arm; barrel cortex; biomaterial compatibility; brain computer interface; cranium; density; design; efficacy testing; implantable device; improved; in vivo; manufacture; microsystems; minimally invasive; model design; neural; neurophysiology; neurosurgery; novel; novel strategies; patient subsets; recruit; response; safety study; safety testing; sheep model; tool; translational goal; usability; virtual; volunteer

Abstract Currently, the brain-computer interface (BCI) field has demonstrated two distinct device strategies - macroelectrodes (e.g., surface grids and depth) versus microelectrode arrays, and some are even pushing the field to smaller, higher density arrays hoping to address the general signal degradation. Both approaches have been in development for decades. However, BCI devices to treat aphasia, dysarthria, or locked-in syndrome also need to access deeper brain regions given the very large, parallel networks involved in speech. Consider that two-thirds of the cortex is buried beyond the reach of most state-of-the-art technologies. We have designed a novel approach to brain recordings to address the challenge of multi-scale recordings at any desired depth. Our team presents a novel device whose form is based on the proven safety and utility of the stereo-EEG (SEEG). We created a directional and scalable local field potential array (DISC) using the phenomenon of "substrate shielding". This is not the first combination micro/macro device but is the first to demonstrate stereo-local field potentials using a patent pending design. Our preliminary in vivo data demonstrates significant improvement when using DISC in many critical factors predictive of future BCI performance: (i) signal amplitude, (ii) signal-to-noise ratio, and (iii) source separation in classification tasks. This project will allow us to safely test word decoding performance both offline and online in epilepsy volunteers from speech regions. The project's first aim is to develop a robust DISC hybrid assembly with 128 or more recording channels per implant. Each implanted device will be a commercially available SEEG combined with microelectrodes without any modification to the clinical function of the device. Aim 1 will include verification, validation, biocompatibility, and electrical safety testing. Aim 1 will also include functional and safety studies in animals to complete our effort to provide a safe, reliable system prior to human feasibility studies. After all milestones are met, including receiving an FDA investigational device exemption, this novel recording system will demonstrate the effect size and variance of word and speech decoding in humans as compared with conventional ring electrodes. Typically, 12-20 depth arrays are used in epileptogenic monitoring and we will replace two depth electrodes with a DISC hybrid assembly in 8 experimental patients and compare decoding performance to the within-patient controls and with a separate 8 patients having SEEG electrodes only. Enrolled volunteers will conduct overt and covert speech tasks. Positive results will inform and enable a word and speech decoder for persons suffering from locked-in syndrome and eventually non-fluent aphasia.

摘要 目前，脑机接口（BCI）领域已经展示了两种不同的设备策略-宏电极 (e.g.,表面网格和深度）与微电极阵列，有些甚至推动该领域， 更小，更高密度的阵列，希望解决一般的信号退化。这两种方法都在 几十年的发展。然而，治疗失语症、构音障碍或闭锁综合征的脑机接口设备还需要 来进入大脑更深的区域，因为语言涉及到非常大的并行网络。考虑到三分之二 大多数先进技术都无法触及。 我们设计了一种新颖的大脑记录方法，以解决多尺度记录的挑战， 任何想要的深度。我们的团队提出了一种新的设备，其形式是基于已证明的安全性和实用性， 立体脑电图（SEEG）。我们创建了一个方向性和可扩展的局部场电位阵列（DISC），使用 “衬底屏蔽”现象。这不是第一个组合微/宏设备，但却是第一个 使用正在申请专利的设计展示立体局部场电位。我们的初步体内数据 在预测未来BCI的许多关键因素中使用DISC时，显示出显著改善 性能：（i）信号幅度，（ii）信噪比，和（iii）分类任务中的源分离。这 该项目将使我们能够安全地测试癫痫志愿者的离线和在线单词解码性能， 言语区 该项目的第一个目标是开发一个强大的光盘混合组装128个或更多的记录通道， 植入每种植入器械将是市售SEEG与微电极的组合， 器械临床功能的任何修改。目标1将包括验证、确认、生物相容性， 电气安全测试。目标1还将包括动物的功能和安全性研究，以完成我们的努力 在人类可行性研究之前提供一个安全可靠的系统。 在达到所有里程碑后，包括获得FDA试验用器械豁免， 系统将展示人类单词和语音解码的效果大小和方差， 传统的环形电极。通常，12 - 20个深度阵列用于癫痫监测，我们将 在8名实验患者中用DISC混合组件替换两个深度电极，并比较解码 与患者内对照相比，单独的8名患者仅具有SEEG电极。入组 志愿者将进行显性和隐性的演讲任务。积极的结果将通知和使一个词和讲话 解码器的人患有闭锁综合征和最终非流利失语症。