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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

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.

项目总结