Multichannel Vestibular Prosthesis Pilot Early Feasibility Trial

多通道前庭假体试点早期可行性试验

• 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
• 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

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）：双侧前庭功能丧失（内耳平衡感）是致残性的，受影响的个体患有慢性平衡失调，风险增加 福尔斯，以及在日常生活中头部运动时不能保持稳定的视力。虽然大多数部分丧失的人通过恢复其他感官的策略来补偿，但那些无法补偿的深度丧失者没有很好的治疗选择。因为在许多这样的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，就像耳蜗植入物恢复听觉功能一样。 拟议的研究计划代表了五步计划的第四步，为双侧前庭功能障碍的患者开发有效的治疗方法。第一步是建立啮齿类动物3D VOR假体修复的神经生理学基础。第2步包括开发第一个能够恢复3D头部旋转感觉的多通道头戴式前庭假体。第3步优化了啮齿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-将通过对改装后的人工耳蜗植入物进行早期可行性研究，将MVP技术从恒河猴转移到人类身上，以用作前庭假体，为MVP设计的最终修订和随后的大规模关键试验奠定基础。