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 双侧前庭感觉丧失是致残的，受影响的个体患有慢性平衡失调， 福尔斯的风险增加，以及在日常生活中头部运动时不能保持稳定的视力。最 轻度或中度损失的人通过恢复其他感官的策略进行补偿; 然而，那些严重损失而又无法补偿人没有好的治疗选择。老年 那些已经在与视力、本体感觉和其他系统的下降作斗争的人， 通常有助于维持平衡，缺乏补偿性储备可能会导致前庭功能丧失 更有冲击力的感觉。幸运的是，当前庭神经在解剖学上是完整的，就像在 在大多数情况下，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，就像耳蜗植入部分恢复听觉一样。在第一次人类 早期可行性研究，旨在测试长期人工前庭神经的安全性和有效性 我们对8例年龄在18岁左右的成年人进行了单侧前庭神经植入术， 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24小时/天的运动调制假体刺激，目标是三个植入的 半规管驱动定向排列的前庭眼反射，改善客观的措施， 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，在这方面， 我们还不知道这种感觉恢复治疗是否对老年人有效，他们被认为 更难以适应来自两个前庭神经节的输入的不对称性。在一个 已建立的设计，经验丰富的研究团队和方案，已经产生了非常有影响力的结果， 现有的年轻受试者的研究，拟议的研究将扩大这种方法，老年人残疾 双侧前庭功能减退结果很有可能产生持续的影响，通过澄清相对 在老年人中进行这种干预的风险和益处，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支付者关于老年人是否因双侧前庭功能障碍而残疾， 损失应获得前庭植入。