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.

项目摘要 神经损伤导致沟通的丧失是毁灭性的。这项试点试验的目的是 评估语言修复技术在一小群瘫痪患者中的可行性。我们将利用 对人类语言运动皮层功能特性进行了长达十年的科学研究， 植入电极（用于癫痫手术）的正常讲话患者的语音解码演示 规划）。我们提出了一个早期的可行性研究，长期的直接神经接口恢复的 通信我们提出了三个关键的创新，以实现这一目标：1）长期植入高- 密度128通道皮层电图（ECoG）阵列，从整个外侧运动皮层采样 （包括语音运动皮层），2）最先进的神经网络解码方法的应用，以及3） 直接比较文本和语音合成解码器的方法。皮质电图是一种 使用非穿透电极记录来自脑表面的神经活动（局部场电位）。我们 假设ECoG在临床应用中可能比当前的替代方案（例如， 微电极或头皮EEG），因为我们可以实现高密度采样并覆盖整个语音 运动皮层我们以前已经证明，这种规模和覆盖面是必要的，也是足够的， 解码完整个体的语言ECoG的安全性和可靠性越来越得到充分证明， 长期植入人类医疗应用，如癫痫和脑机接口。我们有 FDA IDE和当地IRB批准用于研究用途，已经消除了监管障碍的风险。主 这项研究的目标是通过从神经信号解码的文本和合成语音实现通信。 第二个目标是证明在慢性脑梗死患者中基于ECoG的记录的稳健性和稳定性。 植入设置。这些目标将决定言语神经修复技术在目标的可行性 瘫痪的病人。