Pilot Clinical Trial of Deep Brain Stimulation for Tinnitus

脑深部刺激治疗耳鸣的临床试验

• 批准号: 8685943
• 负责人: STEVEN WAN CHEUNG
• 金额: $ 65.4万
• 依托单位: NORTHERN CALIFORNIA INSTITUTE/RES/EDU
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8685943
• 关键词: Acoustics; Activities of Daily Living; Adult; Affect; Area; Auditory; Auditory area; Awareness; Basal Ganglia; Behavior; Behavioral; Bilateral; Biological Assay; Brain; Caring; Case Series; Case Study; Cell Nucleus; Chronic; Clinical; Clinical Trials; Complex; Conscious; Corpus striatum structure; Data; Deep Brain Stimulation; Devices; Disabled Persons; Disease; Distress; Dorsal; Ear; Electric Stimulation; Equipment; Equipment and supply inventories; Esthesia; Europe; Extinction (Psychology); Felis catus; Foundations; Functional Magnetic Resonance Imaging; General Population; Head; Hearing; Hearing Aids; Human; Impairment; Implant; Loudness; Magnetic Resonance Imaging; Magnetism; Measures; Metric; Military Personnel; Monkeys; Moods; Movement Disorders; Noise; Operative Surgical Procedures; Otolaryngologist; Patients; Pattern; Procedures; Public Health; Qualifying; Reaction; Refractory; Reporting; Research; Rest; Safety; Selection Criteria; Severities; Sleep; Stimulus; Stroke; Structure; Symptoms; Techniques; Technology; Thalamic structure; Therapeutic; Tinnitus; Translations; Validation; base; caudate nucleus; clinical practice; disability; emotional reaction; experience; handicapping condition; hearing impairment; implantation; indexing; innovation; instrumentation; medical attention; neurobehavioral; neuropsychiatry; neuroregulation; public health relevance; relating to nervous system; sound; treatment effect

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.

描述（由申请人提供）：耳鸣是一种幻觉听觉障碍，影响 10-15% 的普通人群。在没有外部声音的情况下，一只或两只耳朵会持续发出铃声、嘶嘶声、嗡嗡声、轰鸣声和其他声音。这个问题日益严重，因为婴儿潮一代和军事人员接触有害噪音通常会引发症状。虽然大多数患有慢性耳鸣的患者会在很大程度上忽略他们的声感觉，但有些患者会对幻听产生情绪反应，并遭受睡眠、情绪和日常生活活动的损害。在美国和欧洲，有一千三百万耳鸣患者寻求医疗救助。超过 100 万人患有持续不断的症状，这些症状对现有的治疗方法（例如助听器、神经行为消声程序以及听觉皮层的磁或电刺激）无效。那些耳鸣患者几乎没有治疗手段。 慢性耳鸣的一种潜在新疗法是阻止与耳鸣相关的大脑活动到达大脑中枢，从而强化对幻听的不良行为反应。通过对尾状核的 LC 区域应用深部脑刺激 (DBS)，具有知觉后果的病理性神经活动将被消除或忽略。我们建议在患有慢性耳鸣的严重或非常严重问题的成人中进行区域 LC 的 DBS 试点临床试验。该项目的具体目标是：1）估计 LC 区 DBS 对耳鸣严重程度的治疗效果大小，2）评估 LC 区 DBS 的初步安全性和耐受性。