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: 8479944
• 负责人: STEVEN WAN CHEUNG
• 金额: $ 72.87万
• 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/8479944
• 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）：耳鸣是一种影响10-15％普通人群的幻像听觉障碍。在没有外部声音的情况下，持续的响起，嘶嘶声，嗡嗡声，咆哮和其他声音局部被局部或两只耳朵。问题正在增加，因为婴儿潮一代和军事人员的噪音暴露通常会引发症状。尽管大多数患有慢性耳鸣的患者在很大程度上会忽略他们的声学感觉，但有些患者会对他们的听觉幻影产生情感反应，并遭受睡眠，情绪和日常生活活动的障碍。在U和欧洲，有1300万用耳鸣寻求医疗救助。超过100万的症状遭受了对既定治疗方法难治性的症状，例如助听器，神经行为声音灭绝程序以及听觉皮层的磁性或电刺激。那些耳鸣的患者几乎没有治疗性。 慢性耳鸣的一种潜在新治疗方法是阻止耳鸣相关的大脑活动到达脑中心，从而增强对听觉幻影的不良行为反应。通过将深脑刺激（DBS）应用于尾状核的LC区域，将消除或忽略具有感知后果的病理神经活动。我们在LC地区提出了DBS的试验临床试验，该试验患有慢性耳鸣的成年人有很大或很大的问题。该项目的具体目的是：1）估计LC区域中DBS对耳鸣严重程度的治疗效果大小，以及2）评估DBS在LC​​区域的初步安全性和耐受性。