Pilot Clinical Trial of Deep Brain Stimulation for Tinnitus

描述（由申请人提供）：耳鸣是一种影响10-15%普通人群的幻肢听觉障碍。在没有外部声音的情况下，有持续的铃声，嘶嘶声，嗡嗡声，咆哮声和其他声音局限于一只或两只耳朵。这个问题越来越严重，因为婴儿潮一代和军事人员接触有害噪音往往会引发症状。虽然大多数慢性耳鸣患者会在很大程度上忽视他们的听觉，但有些人会对他们的听觉幻象产生情绪反应，并在睡眠，情绪和日常生活活动方面受到损害。在美国和欧洲有1300万耳鸣患者寻求医疗帮助。超过100万人患有顽固性症状，这些症状对现有治疗方法无效，例如助听器，神经行为声音消除程序以及听觉皮层的磁或电刺激。耳鸣的危害有哪些？ 慢性耳鸣的一种潜在的新治疗方法是阻止耳鸣相关的大脑活动到达大脑中心，从而加强对听觉幻象的不良行为反应。通过将脑深部电刺激（DBS）应用于尾状核的LC区，具有感知后果的病理性神经活动将被消除或忽略。我们提出了一个试点的临床试验DBS在LC区的成年人有一个大的或非常大的问题，慢性耳鸣。本项目的具体目的是：1）估计LC区DBS对耳鸣严重程度的治疗效应大小，2）评估LC区DBS的初步安全性和耐受性。

DESCRIPTION (provided by applicant): Tinnitus is a phantom auditory disorder that affects 10-15% of the general population. In the absence of external sounds, there is constant ringing, hissing, buzzing, roaring and other sounds localized to one or both ears. The problem is growing because injurious noise exposure in baby boomers and military personnel can often trigger symptoms. Whereas most patients with chronic tinnitus will largely ignore their acoustic sensation, some will have emotional reactions to their auditory phantom and suffer from impairments in sleep, mood, and activities of daily living. Thirteen million with tinnitus in the U and Europe seek medical attention. Over 1 million suffer from unremitting symptoms that are refractory to established treatments, such as hearing aids, neurobehavioral sound extinction procedures, and magnetic or electrical stimulation of auditory cortex. Those tinnitus sufferers have little therapeutic recourse. A potential new treatment for chronic tinnitus is to block tinnitus-related brain activity from reaching brain centers that reinforce adverse behavioral reactions to the auditory phantom. By applying deep brain stimulation (DBS) to area LC of the caudate nucleus, pathological neural activity with perceptual consequences will either be eliminated or ignored. We propose a pilot clinical trial of DBS in area LC in adults with a big or very big problem with chronic tinnitus. The specific aims of this project are: 1) to estimate the treatment effect size of DBS in area LC on tinnitus severity, and 2) assess preliminary safety and tolerability of DBS in area LC.