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 导致沟通丧失的神经损伤是毁灭性的。该提议的试点试验设计 评估一小群瘫痪的患者队列中语音假肢技术的可行性。我们将利用 对人类语音运动皮层的功能特性的长达十年的科学研究，最近 植入电极的常态患者的语音解码（用于癫痫手术） 规划）。我们建议对长期直接神经界面进行早期可行性研究，以恢复 沟通。我们提出三项关键创新来实现这一目标：1）长期植入的高级创新 密度128通道电视学（ECOG）阵列，该阵列从整个侧向运动皮质中取样 （包括语音运动皮层），2）最先进的神经网络解码方法的应用，3） 文本和语音合成解码器方法的直接比较。电视学是一种方法 使用非穿透电极从脑表面记录神经活动（局部场电位）。我们 假设ECOG在临床应用方面可能与当前替代方案具有不同的优势（例如 鉴于我们可以实现高密度采样并覆盖整个语音，微电极或头皮脑 运动皮层。我们以前已经证明，这种规模和覆盖范围是必要的，足以满足 在完整的个体中解码语音。 ECOG的安全性和可靠性越来越多 人类医学应用中的长期植入等癫痫和脑计算机界面。我们有 与FDA IDE和当地IRB批准有关调查用途的已经脱离风险的监管障碍。主要 该研究的目标是通过文本和综合语音通过神经信号解码。 第二个目标是证明基于ECOG录音的稳健性和稳定性 植入设置。这些目的将确定目标神经假体技术在目标中的可行性 瘫痪的患者人群。