A Pilot Clinical Trial for Speech Neuroprosthesis

言语神经假体的初步临床试验

• 批准号: 10113331
• 负责人: Edward Chang
• 金额: $ 115.81万
• 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/10113331
• 关键词: Brain; Chronic; Clinical Trials; Communication; Electrocorticogram; Electrodes; Electroencephalography; Epilepsy; Feasibility Studies; Goals; Human; Implant; Individual; Institutional Review Boards; Investigation; Lateral; Medical; Methods; Microelectrodes; Motor Cortex; Nervous System Trauma; Operative Surgical Procedures; Paralysed; Patients; Property; Prosthesis; Risk; Safety; Sampling; Scalp structure; Speech; Surface; Target Populations; Technology; Text; base; brain computer interface; clinical application; cohort; density; design; implantation; innovation; neural network; neuroprosthesis; neurotransmission; patient population; pilot trial; relating to nervous system; restoration; speech synthesis

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.

神经损伤导致沟通的丧失是毁灭性的。这项拟议的试点试验旨在评估言语修复技术在一小群瘫痪患者中的可行性。我们将利用长达十年的人类语言运动皮层功能特性的科学研究，以及最近在植入电极（用于癫痫手术计划）的正常说话患者中的语音解码演示。我们提出了一个长期的直接神经接口恢复通信的早期可行性研究。我们提出了三个关键的创新来实现这一目标：1）长期植入的高密度128通道皮层电图（ECoG）阵列，从整个外侧运动皮层（包括语音运动皮层）采样，2）应用最先进的神经网络解码方法，3）文本和语音合成解码器方法的直接比较。皮质电图是一种使用非穿透电极记录大脑表面神经活动（局部场电位）的方法。我们假设，ECoG可能有明显的优势，为临床应用目前的替代品（如微电极或头皮脑电图），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，这种规模和覆盖范围是必要的，足以解码语音在完整的个人。ECoG在人类医疗应用（如癫痫和脑机接口）中的长期植入具有越来越多的有据可查的安全性和可靠性。我们已经消除了FDA IDE和当地IRB批准用于研究用途的监管障碍。该研究的主要目标是通过从神经信号解码的文本和合成语音进行通信。次要目标是证明基于ECoG的记录在慢性植入环境中的稳健性和稳定性。这些目标将确定语言神经修复技术在瘫痪患者目标人群中的可行性。