Vestibular implantation in older adults

老年人的前庭植入

• 批准号: 10419861
• 负责人: Charles C Della Santina
• 金额: $ 51.64万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10419861
• 关键词: 3-Dimensional; Adult; Adverse event; Affect; Age; Anatomy; Auditory; Benefits and Risks; Bilateral; Chronic; Clinical; Clinical Research; Cochlear Implants; Cochlear implant procedure; Cognition; Conscious; Data; Databases; Decision Making; Devices; Disabled Persons; Dizziness; Ear; Effectiveness; Elderly; Electric Stimulation; Equilibrium; Esthesia; Face; Feasibility Studies; Funding; Gait; Goals; Grant; Head; Head Movements; Hearing; Home; Hypesthesia; Impaired cognition; Implant; Incidence; Individual; Intervention; Journals; Knowledge; Laboratories; Labyrinth; Life; Measurement; Measures; Medical; Medicine; Motion; Natural History; Nerve; New England; Observational Study; Operative Surgical Procedures; Outcome; Participant; Patient Outcomes Assessments; Patients; Performance; Perioperative; Persons; Placebos; Policy Maker; Posture; Proprioception; Prosthesis; Protocols documentation; Rehabilitation therapy; Relative Risks; Reporting; Research; Research Design; Risk; Rotation; Running; Safety; Self-Help Devices; Semicircular canal structure; Sensory; Signs and Symptoms; Stimulus; Swimming; System; Testing; Therapeutic; Third-Party Payer; Time; United States Food and Drug Administration; Vestibular Labyrinth; Vestibular Nerve; Vestibular loss; Vision; Walking; Work; age related; aged; arm; burden of illness; cognitive load; cognitive task; cohort; comorbidity; cost; design; disability; effectiveness evaluation; efficacy evaluation; experience; fall risk; falls; first-in-human; follow-up; health related quality of life; hearing impairment; high risk; human old age (65+); implantation; improved; middle age; open label; otoconia; posture instability; rehabilitation strategy; response; restoration; safety testing; senescence; standard of care; vestibular prosthesis; vestibulo-ocular reflex; way finding; young adult

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. Most individuals with mild or moderate loss compensate through rehabilitative strategies enlisting other senses; however, those with severe loss who fail to compensate have no good therapeutic options. For older individuals who are already contending with decreases in vision, proprioception and other systems that normally contribute to maintaining balance, lack of compensatory reserve can make loss of vestibular sensation even more impactful. Fortunately, when the vestibular nerves are anatomically intact, as is true in most such cases, electrical stimuli encoding head rotation can artificially drive nerve activity to partially restore vestibular sensation, much as a cochlear implant partially restores auditory sensation. In the first-in-human early feasibility study designed to test the safety and efficacy of long-term prosthetic vestibular nerve stimulation as a sensory restoration treatment, we performed unilateral vestibular implantation in 8 adults aged 51-66 years old who had been disabled for 2-23 years by bilateral vestibular hypofunction. We found that vestibular implantation and 24 hr/day motion-modulated prosthetic stimulation targeting the three implanted semicircular canals drives directionally-aligned vestibulo-ocular reflexes, improves objective measures of posture and gait, and improves patient-reported dizziness handicap and vestibular-related disability. However, we do not yet know whether this sensory-restoration treatment will work well in older adults, who are thought to have greater difficultly adapting to asymmetry in input from the two vestibular labyrinths. Drawing on an established design, experienced study team and protocol that have already yielded highly impactful results in the existing study of younger subjects, the proposed research will extend this approach to older adults disabled by bilateral vestibular hypofunction. Results are very likely to yield sustained impact, by clarifying the relative risks and benefits of this intervention in older adults and by providing data that can inform decisions by regulators, policy-makers and third-party payers regarding whether older adults disabled by bilateral vestibular loss should have access to vestibular implantation.

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。最多 患有轻度或中等损失的人通过康复策略来补偿其他感觉； 但是，那些未能补偿的严重损失的人没有良好的治疗选择。适用于较老的 已经在视觉，本体感受和其他系统中竞争的个人 通常有助于维持平衡，缺乏补偿储备会导致前庭损失 感觉更具影响力。幸运的是，当前庭神经在解剖学上完好无损时， 大多数这样的情况，编码头部旋转的电刺激可以人为地推动神经活动以部分恢复 前庭感觉，就像人工耳蜗植入物部分恢复听觉感觉。在第一个人类中 早期可行性研究旨在测试长期假肢神经的安全性和功效 刺激作为一种感觉恢复处理，我们在8岁的成年人中进行了单方面的前庭植入 51-66岁的患有双侧前庭功能低下2 - 23年。我们发现 前庭植入和24小时运动调节的假肢刺激针对三个植入 半圆形管驱动定向对准的前庭反射，改善了客观的衡量标准 姿势和步态，并改善患者报告的头晕障碍和与前庭相关的残疾。然而， 我们尚不知道这种感觉恢复治疗在老年人中是否会很好地奏效，他们被认为是 在两个前庭迷宫的输入中，有更大的难以适应不对称性。在一个 建立的设计，经验丰富的学习团队和协议，已经在 现有的对年轻受试者的研究，拟议的研究将向老年人扩展这种方法 通过双侧前庭功能低下。结果很可能通过阐明亲戚来产生持续的影响 这种干预对老年人的风险和利益，并提供可以通过 监管机构，政策制定者和第三方付款人是否涉及双边前庭残疾的老年人 损失应该可以使用前庭植入。