Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction

前庭植入治疗成人发病的双侧前庭功能减退症

基本信息

批准号：
10625287
负责人：
Charles C Della Santina
金额：
$ 55.77万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-21 至 2026-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10625287
关键词：
3-Dimensional Action Potentials Adult Adverse event Affect Anatomy Auditory Authorization documentation Bilateral Brain Chronic Clinical Cochlear Implants Cochlear implant procedure Compensation Conscious Consent Data Databases Devices Disabled Persons Dizziness Ear Effectiveness Electric Stimulation Ensure Equilibrium Esthesia Exclusion Exhibits Feasibility Studies Foundations Future Gait Grant Hair Cells Head Head Movements Hearing Implant Individual Institutional Review Boards Laboratories Labyrinth Life Longterm Follow-up Measures Medical Device Medicine Monitor Motion Multicenter Trials National Institute on Deafness and Other Communication Disorders Nerve Noise Operative Surgical Procedures Outcome Patients Performance Persons Posture Procedures Prosthesis Protocols documentation Recruitment Activity Regulation Rehabilitation therapy Reporting Research Research Design Research Project Grants Rotation Running Safety Sample Size Sampling Scientific Inquiry Semicircular canal structure Signs and Symptoms Solid Stimulus Study Subject Swimming System Technology Testing Therapeutic Thinking United States United States Food and Drug Administration Vestibular Nerve Vestibular loss Vision Walking Work cell injury clinical investigation cognitive load cohort cost design disability effective therapy effectiveness evaluation efficacy evaluation experience fall risk falls first-in-human follow-up health related quality of life hearing impairment implantation improved inclusion criteria ototoxicity patient population posture instability power analysis programs prospective response standard of care vestibulo-ocular reflex volunteer

3-Dimensional Action Potentials Adult Adverse event Affect Anatomy Auditory Authorization documentation Bilateral Brain Chronic Clinical Cochlear Implants Cochlear implant procedure Compensation Conscious Consent Data Databases Devices Disabled Persons Dizziness Ear Effectiveness Electric Stimulation Ensure Equilibrium Esthesia Exclusion Exhibits Feasibility Studies Foundations Future Gait Grant Hair Cells Head Head Movements Hearing Implant Individual Institutional Review Boards Laboratories Labyrinth Life Longterm Follow-up Measures Medical Device Medicine Monitor Motion Multicenter Trials National Institute on Deafness and Other Communication Disorders Nerve Noise Operative Surgical Procedures Outcome Patients Performance Persons Posture Procedures Prosthesis Protocols documentation Recruitment Activity Regulation Rehabilitation therapy Reporting Research Research Design Research Project Grants Rotation Running Safety Sample Size Sampling Scientific Inquiry Semicircular canal structure Signs and Symptoms Solid Stimulus Study Subject Swimming System Technology Testing Therapeutic Thinking United States United States Food and Drug Administration Vestibular Nerve Vestibular loss Vision Walking Work cell injury clinical investigation cognitive load cohort cost design disability effective therapy effectiveness evaluation efficacy evaluation experience fall risk falls first-in-human follow-up health related quality of life hearing impairment implantation improved inclusion criteria ototoxicity patient population posture instability power analysis programs prospective response standard of care vestibulo-ocular reflex volunteer

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项目摘要

Project Summary Bilateral loss of vestibular 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. While most individuals with milder loss compensate through rehabilitative strategies enlisting other senses, those with severe loss who fail to compensate have no good therapeutic options. When the vestibular nerves are anatomically intact, as is true in most such cases, electrical stimuli encoding head rotation can drive nerve activity and partially restore vestibular sensation, much as a cochlear implant partially restores auditory sensation. In an on-going first-in-human early feasibility study of six adults disabled by bilateral vestibular hypofunction after ototoxic hair cell injury, we found that vestibular implantation and motion-modulated prosthetic stimulation targeting the implanted ear's three semicircular canals is a feasible, safe and effective treatment for ototoxic loss, as evidenced by directionally-aligned vestibulo-ocular reflexes reliably elicited during >3 years of continuous use, improvements in objective measures of posture and gait performance, and improvement of patient-reported dizziness handicap and vestibular-related disability. On the strength of those results, the United States Food & Drug Administration (FDA) has invited a request for humanitarian device exemption for treatment of ototoxic loss; however, FDA advised that additional data would be required to support expanding availability of this treatment to individuals with idiopathic loss, who make up the largest proportion of bilateral vestibular hypofunction cases. Drawing on a well-established design, intact study team, and protocol that yielded highly impactful results in the early feasibility study of subjects with ototoxic loss, the proposed research program will extend this approach to adults disabled by idiopathic adult-onset bilateral vestibular hypofunction. Results of this research are highly likely to yield broad, sustained impact, either through support of early regulatory approval (if results of vestibular implantation for treatment of idiopathic loss are as favorable as the results already obtained for ototoxic loss) or by providing the necessary foundational data to support design of a subsequent, large-scale pivotal trial of vestibular implantation for idiopathic loss.

项目摘要双边丧失前庭感觉正在残疾，受影响的个体患有慢性不平衡，跌倒的风险增加，无法在日常生活中典型的头部运动中保持稳定的视力。尽管大多数损失较轻的人通过康复策略来弥补其他感官，这些策略由于无法补偿的严重损失没有良好的治疗选择。当前庭神经是在解剖学上完好无损，在大多数情况下，编码头部旋转的电刺激可以驱动神经活动并部分恢复前庭感觉，就像人工耳蜗植入物部分恢复听觉感觉。在正在进行的一项人类的首次人类早期可行性研究中，六名被双侧前庭残疾耳毒性毛细胞损伤后功能障碍，我们发现前庭植入和运动调节针对植入耳朵的三个半圆形管的假体刺激是可行，安全有效的耳毒性损失的治疗，可靠地引起方向分配的前庭反射证明在持续使用> 3年> 3年期间改善患者报告的头晕障碍和与前庭相关的残疾。关于那些的力量结果，美国食品药品监督管理局（FDA）邀请了人道主义设备的请求治疗耳毒性损失的豁免；但是，FDA建议需要其他数据支持扩大对特发性损失的人的这种治疗的可用性，他们构成了最大的双侧前庭功能低下病例的比例。利用一个完善的设计团队，和方案在对耳毒性损失的受试者的早期可行性研究中产生了高度影响的结果，拟议的研究计划将把这种方法扩展到特发性成人双边残疾人的成年人前庭功能不全。这项研究的结果很可能会产生广泛的，持续的影响通过支持早期的监管批准（如果前庭植入结果治疗特发性损失的结果与已经获得的耳毒性损失所获得的结果或通过提供必要的基础一样有利数据支持随后的前后前庭植入特发性损失的大规模关键试验。