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.

导致沟通丧失的神经损伤是毁灭性的。该提出的试点试验旨在评估一小群瘫痪的患者中语音假体技术的可行性。我们将利用人类语音运动皮层功能性能的长达十年的科学研究，以及在通常讲植入电极（用于癫痫手术计划）的常态患者中进行语音解码的最新演示。我们建议对长期直接神经界面进行早期可行性研究，以恢复交流。我们提出了三项关键创新来实现此目标：1）长期植入的高密度128通道电视学（ECOG）阵列，该阵列从整个侧向运动皮层（包括语音运动皮层）中取样，2）应用最先进艺术神经网络解码方法，以及3）文本和语音合成解码器方法的直接比较。电视学是一种使用非穿透电极从脑表面记录神经活动（局部场电位）的方法。我们假设ECOG在临床应用中可能具有明显的优势，而不是当前的替代方案（例如微电极或头皮EEG），鉴于我们可以同时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，足以解释完整个体中的语音。 ECOG在人类医学应用中具有越来越多的长期植入的安全性和可靠性概况，例如癫痫和大脑计算机界面。我们已经通过FDA IDE和当地IRB批准了调查用途，我们已经脱离了风险的监管障碍。该研究的主要目标是通过文本和从神经信号解码的综合语音进行沟通。次要目标是证明在慢性植入环境中基于ECOG的记录的稳健性和稳定性。这些目标将确定言语神经假体技术在瘫痪的患者的目标人群中的可行性。