Clinical Trial of Transcranial Magnetic Stimulation for Relief of Tinnitus

描述(由申请人提供)： 项目概述/摘要重复经颅磁刺激(RTMS)是一种非侵入性干预，涉及通过线圈将电磁脉冲传递到受试者的头皮。最终，这些能量中的一部分通过头骨传递，并影响潜在神经组织的活动。由于耳鸣与中枢听觉系统中过度的神经活动有关，rTMS有可能减少患者对耳鸣的感觉和耳鸣的严重程度。一些研究人员已经成功地在相对较小的耳鸣患者群体中使用了rTMS。目的：我们的长期目标是开发一种安全、实用、有效和成本效益高的慢性耳鸣治疗方法。这项提议的目标，也是实现我们长期目标的下一步，是在大样本耳鸣患者中进行一项精心设计的、安慰剂对照的rTMS临床试验。这项拟议研究的中心假设是，rTMS可以在较长时间内减少耳鸣的感觉，副作用最小。我们的假设是在支持性的初步研究的基础上提出的。具体目标：我们将检验我们的中心假设，并通过追求以下两个具体目标来实现这一应用的目标：1.在大样本慢性耳鸣患者中进行低频(1赫兹)重复经颅磁刺激(RTMS)的双盲、随机、安慰剂对照临床试验。我们假设，与安慰剂组相比，连续10个工作日每天应用2000个脉冲的1赫兹rTMS治疗组将在统计和临床上显著降低耳鸣的响度和严重程度。2.追踪参与临床试验的受试者治疗后6个月的进展情况。我们假设治疗组在耳鸣响度和严重程度方面的改善将在随访期内持续。安慰剂组在随访期内耳鸣的响度和严重程度不会有明显的变化。研究设计：这将是一项前瞻性、随机、受试者和临床医生/观察者盲法、安慰剂对照的平行组rTMS临床试验，涉及168名耳鸣患者样本。受试者将在连续10个工作日接受主动或安慰剂rTMS治疗。结果将在治疗开始前、每次治疗前和治疗后立即进行评估。在最后一次治疗后1周、2周、4周、13周和26周进行后续评估。这项调查的目标人群(研究结果将推广到这些人群)包括患有烦人的慢性耳鸣的人。影响：在研究结束时，将确定和开发最大限度地发挥rTMS降低耳鸣严重程度的疗效的方案。然后，临床医生将能够以最有效的方式对耳鸣患者进行rTMS治疗，以减轻他们的病情严重程度。 公共卫生相关性： 项目简介：耳鸣(耳朵或头部感觉到铃声或其他幻觉)是所有退伍军人第二普遍的与服务有关的残疾(仅次于听力损失)，每年导致赔偿总额超过5亿美元。由于慢性耳鸣是一种对全球数百万人的生活质量产生负面影响的疾病，包括美国退伍军人和军事人员，几十年来一直在寻求安全有效的耳鸣治疗方法。然而，对于耳鸣最常见的病因，真正的“治愈”方法仍然难以捉摸。拟议的临床试验将评估重复经颅磁刺激(RTMS)在减少患者感觉和耳鸣严重程度方面的疗效。在退伍军人管理局和美国武装部队医疗保健系统中使用这种治疗方法将改善退伍军人和军事人员的生活质量。在全美各地的医疗诊所实施rTMS疗法将有助于减少因烦人的耳鸣而经历、接受治疗和获得补偿的人数。

DESCRIPTION (provided by applicant): Project Summary/Abstract Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive intervention that involves delivering electromagnetic pulses through a coil to the subject's scalp. Ultimately, some of this energy is transmitted through the skull and affects the activity of underlying neural tissue. Because tinnitus is associated with superfluous neural activity in the central auditory system, rTMS has the potential to reduce patients' perception and severity of tinnitus. Several investigators have used rTMS successfully on relatively small populations of tinnitus patients. Objective: Our long-range goal is to develop a safe, practical, effective and cost-effective treatment for chronic tinnitus. The objective of this proposal, the next step toward attaining our long-range goal, is to conduct a well-designed, placebo-controlled clinical trial of rTMS in a large sample of tinnitus sufferers. The central hypothesis of the proposed research is that rTMS can reduce the perception of tinnitus for prolonged periods of time with minimal adverse side effects. Our hypothesis has been formulated on the basis of supportive preliminary studies. Specific Aims: We will test our central hypothesis and accomplish the objective of this application by pursuing the following two specific aims: 1. Conduct a double-blinded, randomized, placebo-controlled clinical trial of low frequency (1 Hz) repetitive transcranial magnetic stimulation (rTMS) in a large sample of people who experience chronic tinnitus. We hypothesize that application of 2000 pulses of 1 Hz rTMS daily for 10 successive work days will result in statistically and clinically significant reductions in tinnitus loudness and severity for the treatment group compared to the placebo group. 2. Track the progress of subjects who participated in the clinical trial for six months post- treatment. We hypothesize that improvements in tinnitus loudness and severity experienced by the treatment group will be sustained during the follow-up period. The placebo group will not experience significant changes in tinnitus loudness and severity during the follow-up period. Study Design: This will be a prospective, randomized, subject and clinician/observer blind, placebo- controlled parallel-group clinical trial of rTMS involving a sample of 168 people who experience tinnitus. Subjects will receive either active or placebo rTMS therapy on 10 consecutive work days. Outcomes will be measured prior to the start of treatment, immediately before and after each therapeutic session. Follow- up evaluations will be conducted 1, 2, 4, 13 and 26 weeks after the last treatment session. The target population (to whom the study findings will be generalized) for this investigation includes people who experience bothersome, chronic tinnitus. Impact: At the conclusion of the study, protocols will be identified and developed that maximize the efficacy of rTMS to reduce tinnitus severity. Clinicians will then be able to administer rTMS therapy to tinnitus patients in the most effective ways to reduce the severity of their condition. PUBLIC HEALTH RELEVANCE: Project Narrative: Tinnitus (the perception of ringing or other phantom sounds in the ears or head) is the second most prevalent service-connected disability (after hearing loss) for all Veterans and results in compensation payments totaling more than $500 million per year. Because chronic tinnitus is a condition that negatively impacts the quality of life for millions of people worldwide, including U.S. Veterans and military personnel, a safe and effective treatment for tinnitus has been sought for decades. However, a true "cure" for the most common etiologies of tinnitus remains elusive. The proposed clinical trial will assess the efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing patients' perception and severity of tinnitus. Utilization of this treatment throughout the VA and U.S. Armed Forces health care systems will improve the quality of life for Veterans and military personnel. Implementation of rTMS therapy in medical clinics across the United States will help to reduce the number of people who experience, are treated for, and receive compensation for bothersome tinnitus.