Stimulating the cochlear apex without longer electrodes

无需较长电极即可刺激耳蜗尖部

• 批准号: 10461862
• 负责人: David M Landsberger
• 金额: $ 21.19万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-04 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10461862
• 关键词: Acoustics; Address; Affect; Apical; Caliber; Clinical; Cochlea; Cochlear Implants; Cochlear duct; Code; Computer software; Devices; Disadvantaged; Discrimination; Ear; Electric Stimulation; Electrodes; FDA approved; Felis catus; Frequencies; Human; Implant; Implanted Electrodes; Inferior Colliculus; Intervention; Intervention Studies; Lead; Left; Length; Maps; Measures; Methods; Modification; Operative Surgical Procedures; Outcome; Patients; Perception; Performance; Phase; Probability; Reporting; Residual state; Scala Tympani; Site; Speech; Speech Perception; Structure; Tissues; design; electric field; experimental study; helicotrema; implantable device; implantation; improved; normal hearing; novel; novel strategies; relating to nervous system; signal processing; sound; temporalis muscle

PROJECT SUMMARY Cochlear implant (CI) electrode arrays are only partially inserted into the cochlea, in most cases leaving more than half of the cochlea unstimulated. In the normal hearing ear, the cochlear region left unstimulated by most CIs represents frequencies below approximately 800Hz. Providing electrical stimulation to a broader region of the cochlea with a CI has the potential to enhance performance. For example, increasing apical coverage has been shown to improve speech perception and accelerate CI patients’ adaptation to their device. These benefits may be due to representation of low-frequency information closer to the normal cochlear place. Furthermore, stimulation deeper than one cochlear turn may provide better perception of temporal information and better sound quality. However, using longer electrode arrays to access deep apical regions has several disadvantages. First, because the scala tympani diameter decreases with increasing cochlear depth, the likelihood of an incomplete insertion increases with electrode array length. Second, if deeper insertion is achieved, the probability of damage to cochlear structures increases as the walls of the cochlear duct become closer to the electrode. Third, even the longest electrodes only stimulate ~70% of the cochlear length. To address these shortcomings, we developed a novel approach to stimulate the cochlear apex without increasing the electrode array length. Moreover, our approach uses existing FDA-approved CIs, speech processors, and commercial fitting software without modification. In Cochlear CI devices, two extra-cochlear electrodes (ECEs) are used for grounds: ECE1 (usually placed under the temporalis muscle) and ECE2 (located on the implant case). In the novel approach, ECE1 is placed into the cochlear helicotrema via an apical cochleostomy and the electrode array is inserted from the basal end of the cochlea through a traditional cochleostomy. When an electrode from the array is grounded to ECE1 in the cochlear helicotrema, the electric field is driven towards the cochlear apex, stimulating residual neural tissue at sites deeper than available with the standard configuration of electrode arrays and ground electrodes. Using ECE2 as the ground provides monopolar stimulation, which is the clinical standard. Thus far, we have successfully implanted three patients using this novel surgical approach and implemented novel signal processing using the ECE1 electrode. All reported a lower pitch when using ECE1 instead of ECE2 as a ground. This new approach provides a unique opportunity to answer important scientific questions and to evaluate a new clinical intervention. It provides the first opportunity to directly stimulate the cochlear helicotrema (apex) in humans. We can now study if such stimulation improves temporal coding (Aim 1) and extends the tonotopic pitch range (Aim 2). Additionally, we can study if the intervention improves clinical outcomes (Aim 3). We propose to implant 15 patients with this new approach to address the three aims.

项目概要 人工耳蜗 (CI) 电极阵列仅部分插入耳蜗，在大多数情况下会留下 超过一半的耳蜗未受到刺激。在正常听力的耳朵中，耳蜗区域不受外界刺激 大多数 CI 代表低于约 800Hz 的频率。为更广泛的范围提供电刺激 具有 CI 的耳蜗区域有可能提高性能。例如，增加心尖 事实证明，覆盖范围可以改善语音感知并加速 CI 患者对其设备的适应。 这些好处可能是由于低频信息的表示更接近正常耳蜗位置。 此外，比耳蜗一圈更深的刺激可能会提供更好的时间信息感知 和更好的音质。然而，使用较长的电极阵列来进入深根尖区域有几个问题 缺点。首先，由于鼓阶直径随着耳蜗深度的增加而减小， 不完全插入的可能性随着电极阵列长度的增加而增加。其次，如果插入更深 当耳蜗管壁变得 更靠近电极。第三，即使是最长的电极也只能刺激约 70% 的耳蜗长度。 为了解决这些缺点，我们开发了一种刺激耳蜗尖部的新方法 无需增加电极阵列长度。此外，我们的方法使用现有的 FDA 批准的 CI、语音处理器和商业验配软件无需修改。在科利耳 CI 设备中， 两个耳蜗外电极 (ECE) 用于接地：ECE1（通常放置在颞肌下方） 肌肉）和 ECE2（位于植入物外壳上）。在新颖的方法中，ECE1 被放置在耳蜗中 通过心尖耳蜗造口术进行螺旋体手术，并从耳蜗基端插入电极阵列 通过传统的耳蜗造口术。当阵列中的电极接地到耳蜗中的 ECE1 时 helicotrema，电场被驱动到耳蜗尖部，刺激该部位的残余神经组织 比电极阵列和接地电极的标准配置更深。使用 ECE2 因为地面提供单极刺激，这是临床标准。至此，我们已经成功 使用这种新颖的手术方法植入三名患者并实施新颖的信号处理 使用 ECE1 电极。当使用 ECE1 而不是 ECE2 作为接地时，所有人都报告音调较低。 这种新方法提供了一个独特的机会来回答重要的科学问题并 评估新的临床干预措施。它提供了第一次直接刺激耳蜗的机会 人类中的helicotrema（顶端）。我们现在可以研究这种刺激是否可以改善时间编码（目标 1）以及 扩展音调音高范围（目标 2）。此外，我们可以研究干预措施是否改善临床 结果（目标 3）。我们建议为 15 名患者植入这种新方法来实现这三个目标。

项目成果

Stimulating the Cochlear Apex Without Longer Electrodes: Preliminary Results With a New Approach.

• DOI: 10.1097/mao.0000000000003529
• 发表时间: 2022-06-01
• 期刊: OTOLOGY & NEUROTOLOGY
• 影响因子: 2.1
• 作者: Landsberger, David M.;Stupak, Natalia;Spitzer, Emily R.;Entwisle, Lavin;Mahoney, Laurel;Waltzman, Susan B.;McMenomey, Sean;Friedmann, David R.;Svirsky, Mario A.;Shapiro, William;Roland, J. Thomas, Jr.
• 通讯作者: Roland, J. Thomas, Jr.