Multichannel Vestibular Prosthesis Pilot Early Feasibility Trial

多通道前庭假体试点早期可行性试验

基本信息

批准号：
8612561
负责人：
Charles C Della Santina
金额：
$ 50.11万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-17 至 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8612561
关键词：
3-Dimensional Action Potentials Acute Address Advanced Development Affect Animals Auditory Bilateral Canned Foods Chronic Clinical Clinical Data Clinical Trials Cochlear Implants Cochlear Nerve Code Computer Simulation Coupling Development Devices Disabled Persons Disease Dizziness Economics Electrodes Equilibrium Esthesia Facial nerve structure Feasibility Studies Foundations Frequencies Gait Gentamicins Goals Head Head Movements Hearing Human Hybrids Implant Individual Industry Injury Institutional Review Boards Labyrinth Life Macaca mulatta Measures Nerve Neuraxis Neurons Performance Physiologic pulse Power Sources Prosthesis Prosthesis Design Protocols documentation Quality Control Reflex action Regulation Rehabilitation therapy Reporting Research Rodent Rotation Safety Solid Staging Stimulus Surgeon System Technology Testing Therapeutic Translating Translational Research Trauma United States Food and Drug Administration Vertigo Vestibular Nerve Vestibular loss Vision clinical application clinical practice design effective therapy fall risk implanted sensor improved next generation nonhuman primate novel ototoxicity pilot trial pre-clinical programs prototype public health relevance rehabilitation strategy research and development research study response restoration sensor vector vestibular prosthesis vestibular reflex vestibulo-ocular reflex

项目摘要

DESCRIPTION (provided by applicant): Bilateral loss of vestibular function (inner ear balance sensation) is disabling, with affected individuals suffering chronic disequilibrium, increased risk of falls, and inability to maintain stable vision during head movements typical of daily life. Whil most individuals with partial loss compensate through rehabilitative strategies enlisting other senses, those with profound loss who fail to compensate have no good therapeutic options. Because the vestibular nerves are intact in many such cases, electrical stimuli encoding head rotation should be able to drive the nerve and restore sensation of head movement, much like a cochlear implant restores auditory function. The proposed research program represents the fourth step of a five-step plan to develop an effective treatment for individuals disabled by bilateral vestibular deficiency. Step 1 was to establish a neurophysiologic foundation for prosthetic restoration of the 3D VOR in rodents. Step 2 comprised development of the first multichannel, head-mounted vestibular prosthesis able to restore sensation of 3D head rotation. Step 3 optimized stimulus protocols and electrode designs in rodents and then transitioned experiments from acute to chronic and from rodents to nonhuman primates. Step 4 - the current proposal - will translate MVP technology from rhesus monkeys to humans via an early feasibility study of a modified cochlear implant adapted to serve as a vestibular prosthesis, setting the stage for final revisions to MVP designs and a subsequent, large-scale pivotal trial.

描述（由申请人提供）：双侧前庭功能（内耳平衡感觉）丧失导致残疾，受影响的个体患有慢性不平衡，风险增加跌倒，以及在日常生活中典型的头部运动时无法保持稳定的视力。虽然大多数部分丧失的人通过利用其他感官的康复策略进行补偿，但那些无法补偿的严重丧失的人没有好的治疗选择。由于在许多此类情况下前庭神经是完整的，编码头部旋转的电刺激应该能够驱动神经并恢复头部运动的感觉，就像人工耳蜗恢复听觉功能一样。拟议的研究计划是为因双侧前庭缺陷而致残的个体开发有效治疗方法的五步计划的第四步。第 1 步是为啮齿类动物 3D VOR 的假体修复建立神经生理学基础。第 2 步包括开发第一个多通道、头戴式前庭假体，能够恢复 3D 头部旋转的感觉。第三步优化了啮齿类动物的刺激方案和电极设计，然后将实验从急性过渡到慢性，从啮齿类动物过渡到非人类灵长类动物。第 4 步（目前的提案）将通过对用作前庭假体的改良人工耳蜗植入物进行早期可行性研究，将 MVP 技术从恒河猴转化为人类，为 MVP 设计的最终修订和随后的大规模应用奠定基础。关键审判。