Optimization of a human vestibular prosthesis

人体前庭假体的优化

• 批准号: 9530614
• 负责人: Jay T. Rubinstein
• 金额: $ 50.76万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9530614
• 关键词: Acceleration; Address; Animals; Area; Auditory; Australia; Bilateral; Cell Nucleus; Chronic; Clinical; Cochlear Implants; Computers; Contracts; Coupled; Custom; Data; Development; Device Designs; Devices; Dimensions; Disease; Ear; Electric Stimulation; Electrodes; Equilibrium; Ethics; Exercise; Eye Movements; Freedom; Future; Goals; Head; Hearing; Human; Hybrids; Implant; Individual; Investigation; Ipsilateral; Labyrinth; Lesion; Link; Longitudinal Studies; Macaca mulatta; Measures; Meniere' s Disease; Modeling; Modification; Monitor; Monkeys; National Institute on Deafness and Other Communication Disorders; Operative Surgical Procedures; Patients; Physiologic pulse; Postoperative Period; Productivity; Prostheses and Implants; Prosthesis; Quality of life; Rehabilitation therapy; Research; Risk; Rotation; Safety; Series; Signal Transduction; Stimulus; Surface; System; Technology; Testing; Therapeutic; Vestibular Diseases; Vestibular loss; X-Ray Computed Tomography; abnormal reflex; base; bone; bone loss; cranium; design; disability; effective therapy; equilibration disorder; experience; first grade; functional restoration; hearing impairment; human subject; implantable device; implantation; longitudinal human study; neural prosthesis; nonhuman primate; public health relevance; relating to nervous system; response; safety study; sample fixation; sensor; spinal reflex; success; vestibular prosthesis; vestibulo-ocular reflex; visual image movement

DESCRIPTION (provided by applicant): Vestibular disorders exact a huge toll in lost productivity and quality of life. The bilateral loss of vestibular function is currently a disorder without effective treatment other than rehabilitative strategies which cannot restore normal vestibulo-ocular or vestibulo-spinal reflexes. Due to the extraordinary success of cochlear implants, there has been a major effort to develop a similar neural prosthesis for the diseased vestibular system. We have developed a vestibular neurostimulator, studied it in rhesus monkeys, and performed four human implants under an FDA investigational device exemption for the treatment of uncontrolled Meniere's disease. Our four human subjects have had profound hearing loss postoperatively and significant loss of electrically-evoked responses has been observed in all of our human subjects and some of our monkeys over months postoperatively. We propose a modification to our existing devices to provide greater stability within the labyrinth and to partly restore hearing in the implanted ear. We also propose a detailed series of longitudinal human studies with the new design to characterize the function of a gyroscopic sensor that we have developed for the treatment of vestibular loss as well as safety studies of the new design in non-human primates. These studies will greatly enhance our understanding of the effects of a vestibular implant in humans and allow us to develop an investigational device exemption for the treatment of uncompensated unilateral and bilateral vestibular loss.

描述（由申请人提供）：前庭疾病对生产力失去的生产力和生活质量造成了巨大影响。前庭功能的双边丧失目前是一种疾病 没有有效的治疗方法，除了无法恢复正常前庭或前庭反射的康复策略。由于耳蜗植入物取得了非凡的成功，因此为患病的前庭系统开发了类似的神经假体。我们已经开发了一个前庭神经刺激剂，在恒河猴中研究了它，并在FDA研究装置豁免下进行了四个人植入物，以治疗不受控制的Meniere病。我们的四个人类受试者在术后有严重的听力损失，并且在术后几个月内，在我们的所有人类受试者和一些猴子中都观察到了电诱发的反应的显着丧失。我们建议对现有设备进行修改，以在迷宫中提供更大的稳定性，并在植入的耳朵中部分恢复听力。我们还提出了一系列详细的纵向人类研究，并具有新的设计，以表征我们为治疗前庭损失以及非人类灵长类动物新设计的安全性研究而开发的陀螺传感器的功能。这些研究将大大增强我们对人类前庭植入物影响的理解，并允许我们开发一种研究设备豁免，以治疗无补偿的单侧和双侧前庭损失。

项目成果

Interactions between Auditory and Vestibular Modalities during Stimulation with a Combined Vestibular and Cochlear Prosthesis.

使用组合前庭和耳蜗假体进行刺激期间听觉和前庭模式之间的相互作用。

• DOI: 10.1159/000503846
• 发表时间: 2020
• 期刊: Audiology & neuro-otology
• 影响因子: 1.6
• 作者: Phillips,JamesO;Ling,Leo;Nowack,Amy;Rebollar,Brenda;Rubinstein,JayT
• 通讯作者: Rubinstein,JayT

The Dynamics of Prosthetically Elicited Vestibulo-Ocular Reflex Function Across Frequency and Context in the Rhesus Monkey.

• DOI: 10.3389/fnins.2018.00088
• 发表时间: 2018
• 期刊: Frontiers in neuroscience
• 影响因子: 4.3
• 作者: Phillips JO;Ling L;Nowack AL;Phillips CM;Nie K;Rubinstein JT
• 通讯作者: Rubinstein JT

The vestibular implant: Opinion statement on implantation criteria for research.

• DOI: 10.3233/ves-200701
• 发表时间: 2020
• 期刊: Journal of vestibular research : equilibrium & orientation
• 作者: van de Berg R;Ramos A;van Rompaey V;Bisdorff A;Perez-Fornos A;Rubinstein JT;Phillips JO;Strupp M;Della Santina CC;Guinand N
• 通讯作者: Guinand N