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(申请人提供)：耳鸣是一种幻听障碍，影响10%-15%的普通人群。在没有外部声音的情况下，会有持续不断的铃声、嘶嘶声、嗡嗡声、咆哮声和其他局限于一只或两只耳朵的声音。这个问题越来越严重，因为婴儿潮一代和军人暴露在有害的噪音中往往会引发症状。虽然大多数慢性耳鸣患者在很大程度上会忽略他们的听觉感觉，但一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。美国和欧洲有1300万患有耳鸣的人寻求医疗救治。超过100万人患有顽固的症状，这些症状对现有的治疗方法是难以治愈的，例如助听器、神经行为消音程序以及对听觉皮质的磁或电刺激。这些耳鸣患者几乎没有治疗手段。治疗慢性耳鸣的一种潜在的新疗法是阻止耳鸣相关的大脑活动到达大脑中心，从而加强对听觉幻影的不良行为反应。通过将脑深部刺激(DBS)应用于尾状核的LC区，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LC区对患有严重或非常严重慢性耳鸣问题的成年人进行DBS的试点临床试验。本项目的具体目标是：1)评估DBS在LC区对耳鸣严重程度的治疗效果大小；2)评估DBS在LC区的初步安全性和耐受性。