Pilot Clinical Trial of Deep Brain Stimulation for Tinnitus

描述（由申请人提供）：耳鸣是一种幻听障碍，影响10-15%的普通人群。在没有外界声音的情况下，一只耳朵或两只耳朵会不断地发出铃声、嘶嘶声、嗡嗡声、咆哮声和其他声音。问题越来越严重，因为婴儿潮一代和军人接触有害的噪音往往会引发症状。虽然大多数慢性耳鸣患者在很大程度上忽略了他们的听觉，但有些人会对他们的听觉幻觉产生情绪反应，并遭受睡眠，情绪和日常生活活动的损害。在美国和欧洲，有1300万耳鸣患者寻求医疗救助。超过100万人患有持续的症状，这些症状对现有的治疗方法难以治愈，比如助听器、神经行为消声手术，以及听觉皮层的磁或电刺激。那些耳鸣患者几乎没有治疗手段。一种潜在的治疗慢性耳鸣的新方法是阻止与耳鸣相关的大脑活动到达大脑中枢，从而加强对听觉幻觉的不良行为反应。通过对尾状核LC区进行脑深部电刺激（DBS），可以消除或忽略具有感知后果的病理性神经活动。我们建议在LC区域进行DBS的试点临床试验，用于患有严重或非常严重的慢性耳鸣问题的成年人。本项目的具体目的是：1)评估DBS在LC地区对耳鸣严重程度的治疗效果大小；2)评估DBS在LC地区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.