A Pilot Clinical Trial for Speech Neuroprosthesis

言语神经假体的初步临床试验

• 批准号: 10364681
• 负责人: Edward Chang
• 金额: $ 109.35万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-03 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10364681
• 关键词: Acoustics; Adult; Affect; Algorithms; Amyotrophic Lateral Sclerosis; Area; Articulation; Articulators; Brain; Brain Stem Infarctions; Chronic; Clinical; Clinical Trials; Communication; Communication Tools; Communications Media; Devices; Disease; Electrocorticogram; Electrodes; Electroencephalography; Epilepsy; Feasibility Studies; Feedback; Future; Genetic Transcription; Goals; Human; Impairment; Implant; Individual; Institutional Review Boards; Investigation; Jaw; Language; Larynx; Lateral; Lip structure; Medical; Methods; Microelectrodes; Modeling; Motor; Motor Cortex; Muscular Dystrophies; Myopathy; Nervous System Trauma; Operative Surgical Procedures; Outcome; Paralysed; Patients; Performance; Persons; Play; Population; Production; Property; Prosthesis; Quality of life; Risk; Safety; Sampling; Scalp structure; Signal Transduction; Speech; Speed; Stroke; Study Subject; Surface; System; Target Populations; Technology; Text; Time; Tongue; Training; Weight; Work; auditory feedback; base; brain computer interface; clinical application; cohort; communication device; density; design; implantation; improved; innovation; neural network; neuroprosthesis; neurotransmission; patient population; phrases; pilot trial; primary outcome; recurrent neural network; relating to nervous system; restoration; signal processing; speech synthesis; spelling

PROJECT SUMMARY Neurological injury that results in the loss of communication is devastating. This proposed pilot trial is designed to evaluate the feasibility of speech prosthetic technology in a small cohort of paralyzed patients. We will leverage a decade-long scientific investigation of the functional properties of human speech motor cortex, and recent demonstration of speech decoding in normally speaking patients implanted with electrodes (for epilepsy surgery planning). We propose an early feasibility study of a long-term direct neural interface for restoration of communication. We propose three critical innovations to achieve this goal: 1) a chronically implanted high- density 128 channel electrocorticography (ECoG) array which samples from the entire lateral motor cortex (including speech motor cortex), 2) application of state-of-the-art neural network decoding approaches, and 3) direct comparison of text and speech synthesis decoder approaches. Electrocorticography is a method of recording neural activity (local field potentials) from the brain surface using non-penetrating electrodes. We hypothesize that ECoG may have distinct advantages for clinical application over current alternatives (e.g. microelectrode or scalp EEG) given that we can achieve both high-density sampling and cover the entire speech motor cortex. We have previously demonstrated that this scale and coverage is necessary and sufficient to decode speech in intact individuals. ECoG has an increasing well documented safety and reliability profile for long-term implantation in human medical applications such epilepsy and brain computer interfaces. We have already de-risked regulatory hurdles with FDA IDE and local IRB approval for investigational use. The primary goals of the study are to enable communication via text and synthesized speech decoded from neural signals. The secondary goal is to demonstrate the robustness and stability of ECoG-based recordings in the chronic implantation setting. These aims will determine the feasibility of speech neuroprosthetic technology in target population of patients who are paralyzed.

项目总结 导致沟通障碍的神经损伤是毁灭性的。这项拟议的试点试验旨在 目的：评价语音假体技术在少部分瘫痪患者中应用的可行性。我们将利用 对人类语言运动皮质功能特性的长达十年的科学研究，以及最近 植入电极的正常说话患者的语音解码演示(用于癫痫外科 规划)。我们建议进行一项长期直接神经接口的早期可行性研究，用于修复 沟通。为了实现这一目标，我们提出了三项关键创新：1)一种长期植入的高- 密度128导联皮质脑电(ECoG)阵列，从整个外侧运动皮质取样 (包括语言运动皮质)，2)最先进的神经网络解码方法的应用，3) 直接比较文本和语音合成解码器的方法。皮质脑电图术是一种 使用非穿透电极记录大脑表面的神经活动(局部场电位)。我们 假设ECoG在临床应用上可能比目前的替代方案具有明显的优势(例如： 微电极或头皮EEG)，因为我们可以实现高密度采样和覆盖整个语音 运动皮质。我们以前已经证明，这一规模和覆盖范围是必要和足够的，以 对完好无损的个体进行语音解码。ECOG拥有越来越完善的安全和可靠性配置文件， 长期植入在人类医学上的应用，如癫痫和脑机接口。我们有 已经消除了FDA IDE和当地IRB批准用于研究的监管障碍。初级阶段 这项研究的目标是通过文本和从神经信号解码的合成语音进行交流。 第二个目标是证明基于ECoG的记录在慢性病患者中的稳健性和稳定性 植入设置。这些目标将决定语音神经假体技术在靶区的可行性。 瘫痪患者的数量。