Pediatric Percutaneous Cochlear Implantation Clinical Validation & Implementation

小儿经皮人工耳蜗植入临床验证

• 批准号: 7935302
• 负责人: ROBERT F LABADIE
• 金额: $ 62.24万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-19 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7935302
• 关键词: Acoustic Nerve; Address; Adoption; Adult; Age; Age Distribution; American; Anatomy; Atlases; Brain; Bypass; Child; Childhood; Clinic Visits; Clinical; Clinical Research; Clinical Trials; Cochlea; Cochlear Implants; Cochlear implant procedure; Collaborations; Computer software; Conceptions; Coupling; Databases; Ear; Electrodes; Excision; External Ear; External auditory canal; Face; Facial nerve structure; Funding; General Anesthesia; General anesthetic drugs; Germany; Goals; Grant; Guidelines; Hearing; Hearing Impaired Persons; Hospitals; Hour; Image; Implant; Implantation procedure; Labyrinth; Lateral; Leg; Local anesthesia; Logistics; Mainstreaming; Mastoid process; Medical; Methods; Modification; Nebraska; Operative Surgical Procedures; Outcome; Outpatients; Patients; Population; Procedures; Protocols documentation; Recruitment Activity; Regulation; Rehabilitation therapy; Research; Risk; Safety; Scala Tympani; Scanning; Semicircular canal structure; Site; Social Work; Societies; Structure; Surface; Techniques; Technology; Temporal bone structure; Testing; Time; Translating; United States; Universities; Validation; Work; X-Ray Computed Tomography; base; bone; boys; cost; cranium; design; design and construction; economic impact; experience; hearing impairment; implantation; improved; manufacturing facility; minimal risk; novel; programs; public health relevance; safety testing; skull base; tool

DESCRIPTION (provided by applicant): Access to the inner ear, specifically the cochlea, is currently required for cochlear implant (CI) surgery, in which an electrode array is used to stimulate the auditory nerve and allow deaf people to hear. More than 120,000 CIs have been placed worldwide. Projections indicate that up to 750,000 Americans with severe hearing loss may benefit from CI (Mohr, Feldman, Dunbar et al., 2000) many of whom are children. In our ongoing, NIH-funded adult project (R01 DC008408), we have demonstrated the feasibility of percutaneous cochlear implantation (PCI). PCI reduces CI surgery to a single pass of a drill from the lateral skull base to the cochlea. The drill path is planned and executed via image-guided technology so as to avoid vital adjacent anatomy and hit the target-the scala tympani of the cochlea. In clinical trials we have validated the technique on 15 adult patients with statistical projections indicating 99.9% avoidance of vital anatomy, specifically the facial nerve. In the attached submission, we propose to translate this technology to the pediatric population. To do this, modifications to our technique are necessary. Our current adult technique consists of the following six steps: (i) placing three bone-implanted fiducial markers/anchors surrounding the ear under local anesthesia in an out-patient setting, (ii) obtaining a clinically applicable CT scan, (iii) using the CT scan to plan a surgical trajectory from the surface of the skull to the basal turn of the cochlea avoiding vital anatomy, (iv) constructing a microstereotactic frame to constrain a drill to pass along the planned trajectory (for the adult study, frame construction requires 48 hours), (v) affixing the frame to the bone-implanted anchors, and (vi) employing the frame to confirm the drill trajectory. Because children and adults differ anatomically, we propose to modify our technique by using a large database of pediatric CT scans to produce age-stratified anatomical atlases that will allow us to perform step (iii) in an automated fashion, as we are currently doing for adults with a single atlas. Because federal guidelines prohibit clinical studies on children entailing greater than minimal risk without the prospect of benefit for children, we have substantially modified steps (ii) and (iv) such that both the acquisition of the CT scan and the design and construction of the microstereotactic frame occur simultaneously with traditional CI surgery, thus reducing the risk to an acceptable level under the guidelines. To do this, we have done extensive work incorporating intraoperative CT scanner into our protocols and designed, developed, and tested a novel microstereotactic frame which can be designed and constructed in 30 minutes-well below the shortest surgical time in our review of 2,256 surgeries. We have recruited two additional well-respected CI programs to participate in the study-Boys Town (Omaha, NE) and the busiest CI center in the world, Medical Hospital of Hannover (Hannover, Germany) with whom we have a standing collaboration. Our hope is that this technique, percutaneous cochlear implantation, will make CI surgery quicker, cheaper, and easier to perform, allowing more children to benefit from aural rehabilitation with CIs. PUBLIC HEALTH RELEVANCE: In the United States about 20,000 deaf children have benefitted from cochlear implantation, a 2+ hour surgery that involves removal of a portion of the bone behind the external ear to reach the inner ear, the cochlea, and place a wire which stimulates the cochlea allowing hearing. Using image guided surgical techniques-similar to GPS technology used to provide geographic directions-we have shown that a much less invasive surgical approach is possible by tracking and controlling the path of a drill such that the cochlea may be reached by a single drill-we call this technique Percutaneous Cochlear Implantation (PCI) and have demonstrated it in adult patients. We now propose to test and perform PCI in children with our efforts focused on the differences between adults and children (for example, (i) anatomy and (ii) federal regulations governing research) with the proposed benefits of PCI including decreased operative time, decreased surgical cost, standardized surgery, and possibly even improved hearing outcomes.

描述（由申请人提供）：目前，人工耳蜗植入 (CI) 手术需要进入内耳，特别是耳蜗，其中使用电极阵列来刺激听觉神经并让聋人听到声音。全球已放置超过 120,000 个 CI。预测表明，多达 750,000 名患有严重听力损失的美国人可能会从 CI 中受益（Mohr、Feldman、Dunbar 等人，2000 年），其中许多是儿童。在我们正在进行的 NIH 资助的成人项目 (R01 DC008408) 中，我们证明了经皮人工耳蜗植入 (PCI) 的可行性。 PCI 将 CI 手术简化为从侧颅底到耳蜗的一次钻孔操作。通过图像引导技术规划和执行钻孔路径，以避免重要的邻近解剖结构并击中目标——耳蜗的鼓阶。在临床试验中，我们在 15 名成年患者身上验证了该技术，统计预测表明 99.9% 避免了重要解剖结构，特别是面神经。在所附的意见书中，我们建议将该技术应用于儿科人群。为此，需要对我们的技术进行修改。我们目前的成人技术包括以下六个步骤：（i）在门诊局部麻醉下在耳朵周围放置三个骨植入基准标记/锚，（ii）获得临床适用的 CT 扫描，（iii）使用CT 扫描规划从头骨表面到耳蜗基底转的手术轨迹，避免重要解剖结构，(iv) 构建微立体框架以约束钻头沿着计划轨迹通过（对于（成人研究中，框架构建需要 48 小时），(v) 将框架固定到植入骨的锚固上，以及 (vi) 使用框架确认钻孔轨迹。由于儿童和成人在解剖学上存在差异，因此我们建议通过使用儿科 CT 扫描的大型数据库来生成按年龄分层的解剖图谱来修改我们的技术，这将使我们能够以自动化方式执行步骤 (iii)，正如我们目前正在做的那样拥有单一地图集的成年人。由于联邦指南禁止对儿童进行临床研究，而这些研究的风险大于最小风险，且不会为儿童带来益处，因此我们对步骤 (ii) 和 (iv) 进行了大幅修改，以便 CT 扫描的采集以及微立体定向的设计和构建框架与传统 CI 手术同时进行，从而将风险降低到指南下​​可接受的水平。为此，我们做了大量工作，将术中 CT 扫描仪纳入我们的方案中，并设计、开发和测试了一种新型微立体定向框架，该框架可以在 30 分钟内设计和构建，远低于我们回顾的 2,256 例手术中的最短手术时间。我们还招募了另外两个备受推崇的 CI 项目来参与这项研究：Boys Town（内布拉斯加州奥马哈）和世界上最繁忙的 CI 中心汉诺威医学医院（德国汉诺威），我们与他们有长期合作关系。我们希望这种经皮人工耳蜗植入技术能够使 CI 手术更快、更便宜、更容易进行，让更多的儿童受益于 CI 的听力康复。 公共健康相关性：在美国，大约 20,000 名聋哑儿童从人工耳蜗植入中受益，这是一项 2 个多小时的手术，涉及去除外耳后面的部分骨头以到达内耳（耳蜗），并放置一根导线，将其植入耳蜗中。刺激耳蜗以提供听力。使用图像引导手术技术（类似于用于提供地理方向的 GPS 技术），我们已经证明，通过跟踪和控制钻头的路径，可以采用侵入性小得多的手术方法，这样单个钻头就可以到达耳蜗。这种技术称为经皮人工耳蜗植入术 (PCI)，并已在成年患者中进行了验证。我们现在建议在儿童中测试和实施 PCI，我们的努力重点是成人和儿童之间的差异（例如，(i) 解剖学和 (ii) 管理研究的联邦法规），建议 PCI 的好处包括减少手术时间、减少手术费用、标准化手术，甚至可能改善听力结果。