Phase I Pediatric Auditory Brainstem Implant Clinical Trial

I期儿童听觉脑干植入临床试验

• 批准号: 8793392
• 负责人: Laurie S Eisenberg
• 金额: $ 72.5万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-12 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8793392
• 关键词: Phase; Pediatric; Auditory; Brainstem; Implant

DESCRIPTION (provided by applicant): The multichannel auditory brainstem implant (ABI) has now been used with some benefit in more than 1000 deaf patients worldwide who were not candidates for a cochlear implant (CI). For many years, the ABI was used primarily in adults deafened by Neurofibromatosis-Type 2 (NF2). During the past decade, ABI surgery has been safely performed on non-NF2 children outside of the United States, and results have shown great promise. The overall objective of this Phase I Clinical Trial grant is to evaluate safety in ten pediatric subjects who are not candidates for traditional cochlear implants due to cochlear nerve deficiency, cochlear aplasia, or cochlear ossification. These types of pathologies prevent normal transmission of auditory information between the cochlea and the brainstem. The House Research Institute proposes the first pediatric, non-NF2 ABI clinical trial in the United States. The Primary Aim is to describe the safety aspects of device implant surgery and 12- month use of an ABI in 10 pediatric patients with profound bilateral hearing loss not amenable to other treatments. If the surgical safety analysis shows no greater number of serious surgery-related adverse events than is commonly observed in non-NF2 adults undergoing craniotomy with or without an ABI and no more than four unexpected serious device-related adverse events are observed per these 10 subjects during 12 months of follow-up; then a Phase II study with a larger number of subjects will be proposed. A Secondary Aim will determine whether or not the device provides patients with access to sound (thresholds of 50 dB HL) during a critical period for communication skills development. Efficacy is here defined as access to sound at a level and within the frequency range, known to be associated with speech. Successful outcomes from this Phase I Clinical Trial will provide the necessary information for planning a Phase II investigation.

描述（由申请人提供）：多通道听觉脑干植入物（ABI）目前已在全球超过1000名不适合人工耳蜗（CI）的聋哑患者中使用，并取得了一定的效果。多年来，ABI主要用于2型神经纤维瘤病（NF2）导致的成人耳聋。在过去的十年中，ABI手术已经在美国以外的非nf2儿童中安全地进行，结果显示出很大的希望。这项I期临床试验拨款的总体目标是评估10名由于耳蜗神经缺损、耳蜗发育不全或耳蜗骨化而不适合传统人工耳蜗植入的儿童受试者的安全性。这些类型的病理阻碍了耳蜗和脑干之间听觉信息的正常传递。House研究所提出美国首个儿科非nf2 ABI临床试验。本研究的主要目的是描述10例重度双侧听力损失且无法接受其他治疗的儿童患者使用ABI的安全性。如果手术安全性分析显示严重的手术相关不良事件的数量不高于在有或没有ABI的非nf2成人开颅手术中通常观察到的数量，并且在12个月的随访中，每10名受试者观察到的意外严重器械相关不良事件不超过4个；然后，将提出一项涉及更多受试者的II期研究。辅助目标将确定该设备是否在沟通技能发展的关键时期为患者提供声音（阈值为50 dB HL）。在这里，功效被定义为在一定水平和频率范围内获得声音，已知与言语有关。I期临床试验的成功结果将为规划II期研究提供必要的信息。