Vestibular implantation in older adults

老年人的前庭植入

• 批准号: 10652590
• 负责人: Charles C Della Santina
• 金额: $ 51.91万
• 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/10652590
• 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; Compensation; Conscious; Data; Databases; Decision Making; Devices; Disabled Persons; Dizziness; Ear; Effectiveness; Elderly; Electric Stimulation; Equilibrium; Esthesia; Exclusion; 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; Organ; 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; 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.

项目概要 双侧前庭感觉丧失会导致失能，受影响的个体会遭受慢性失衡， 跌倒的风险增加，并且在日常生活中典型的头部运动时无法保持稳定的视力。最多 轻度或中度丧失的个体通过利用其他感官的康复策略进行补偿； 然而，那些损失严重且无法补偿的人没有好的治疗选择。对于年龄较大的 已经在与视力、本体感觉和其他系统下降作斗争的人 通常有助于维持平衡，代偿储备的缺乏会导致前庭功能丧失 感觉更有影响力。幸运的是，当前庭神经在解剖学上完好无损时，就像在 在大多数此类情况下，编码头部旋转的电刺激可以人为地驱动神经活动以部分恢复 前庭感觉，就像人工耳蜗部分恢复听觉一样。在人类首次 旨在测试长期假体前庭神经的安全性和有效性的早期可行性研究 作为一种感觉恢复治疗，我们对 8 岁成年人进行了单侧前庭植入 51-66岁，因双侧前庭功能减退致残2-23年。我们发现 前庭植入和针对三个植入体的 24 小时/天运动调制假肢刺激 半规管驱动定向排列的前庭眼反射，改善客观测量 姿势和步态，并改善患者报告的头晕障碍和前庭相关残疾。然而， 我们还不知道这种感觉恢复治疗对老年人是否有效，人们认为老年人 更难适应两个前庭迷路输入的不对称性。画在 既定的设计、经验丰富的研究团队和方案已经在以下方面产生了极具影响力的结果 现有针对年轻受试者的研究，拟议的研究将把这种方法扩展到老年人残疾人 双侧前庭功能减退所致。通过澄清相对的结果，结果很可能产生持续的影响 这种干预措施对老年人的风险和益处，并提供可以为决策提供信息的数据 监管机构、政策制定者和第三方付款人关于老年人是否因双侧前庭致残的问题 失去前庭植入应有机会。