DIrectional and SCalable (DISC) Microelectrode Array for Speech Decoding

摘要 目前，脑-机接口(BCI)领域已经展示了两种截然不同的设备策略--大电极 (例如，表面网格和深度)与微电极阵列的对比，一些甚至将电场推向 希望解决一般信号退化的更小、更高密度的阵列。这两种方法都已经在 几十年来的发展。然而，治疗失语症、构音障碍或闭锁综合征的脑机接口设备也需要 考虑到语音中涉及的非常大的并行网络，我们可以进入更深层次的大脑区域。考虑到三分之二 大脑皮层的部分被埋在了大多数最先进的技术所无法企及的地方。 我们设计了一种新的大脑记录方法，以应对多尺度记录的挑战，网址为 任何想要的深度。我们的团队提出了一种新的设备，其形式基于已证明的安全性和实用性 立体脑电信号(SEEG)。我们创建了一个定向和可扩展的局部场势阵列(DISC)，它使用 “衬底屏蔽”现象。这不是第一个微/宏组合设备，但它是第一个 使用正在申请专利的设计演示立体局部场势。我们初步的活体数据 在预测未来BCI的许多关键因素中，使用DISC显示出显著的改善 性能：(I)信号幅度，(Ii)信噪比，(Iii)分类任务中的源分离。这 该项目将允许我们安全地测试癫痫志愿者的离线和在线单词解码性能 语音区。 该项目的第一个目标是开发一种坚固的光盘混合组件，每个组件具有128个或更多记录通道 植入。每个植入的装置将是商业上可用的SEEG与微电极相结合，而不是 对该设备的临床功能的任何修改。目标1将包括验证、确认、生物兼容性、 和电气安全测试。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。 在达到所有里程碑之后，包括获得FDA的调查设备豁免，这一新颖的记录 系统将演示单词和语音解码在人类中的影响大小和变化 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 8例实验患者用圆盘混合组件替换两个深度电极并进行解码比较 与患者内对照和单独的8名仅使用SEEG电极的患者进行比较。已注册 志愿者将进行公开和秘密的演讲任务。积极的结果将通知并启用单词和演讲 为患有闭锁综合征和最终不流利的失语症的人提供解码器。

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.