Maintenace rTMS for chronic tinnitus relief

维持 rTMS 以缓解慢性耳鸣

基本信息

  • 批准号:
    8420445
  • 负责人:
  • 金额:
    $ 14.01万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2012
  • 资助国家:
    美国
  • 起止时间:
    2012-03-01 至 2016-02-28
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): Subjective tinnitus is perception of sound like ringing, buzzing, or hissing in the absence of external stimulation. Tinnitus is a significant neurological disorder that affects 51 million US citizens. There is no cure. Twelve million patients seek treatment for disturbances of sleep, affect and concentration and 3 million are unable to function occupationally. Current treatments do little to actually reduce tinnitus perception. In contrast, repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method of regional brain stimulation that can significantly reduce subjective tinnitus in 50% of patients; however, the treatment effect is temporary, lasting 1 to 2 weeks after a week-long course of standard treatment. Our preliminary work indicates that this limitation can be overcome by changing the way rTMS is applied. We have observed that the rTMS effect on tinnitus is very reliable among persons who respond positively to a standard course of treatment (i.e., treatment responders) and that reapplying rTMS when tinnitus returns (i.e., maintenance treatment) produces added benefits that are sustained over time. We hypothesize that maintenance rTMS works by reversing pathological processes which are set in motion by a loss of normal sensory input (i.e., a thalamocortical dysrhythmia) and we will test this hypothesis using high density EEG recordings before and after treatment. We expect that maintenance treatment will improve tinnitus in an additive fashion and that it will impede relapse relative to standard treatment and to a sham-treatment control. We will focus the study on 30 treatment responders who will receive sham and active maintenance rTMS using a blinded study design with treatment crossover. Thirty non responders will be studied to learn what patient characteristics predict a treatment response. Maintenance treatment will consist of four, 3-day courses of rTMS separated by fixed 3-week intervals. Primary outcome measures will include a questionnaire of tinnitus severity, visual analogue ratings of tinnitus loudness and annoyance, forced- choice measures of improvement/worsening, a physically anchored measures of tinnitus frequency and loudness and the spectral power and coherence of EEG frequency bands. The timing and duration of maintenance treatment effects will be assessed by counting the number of days between the end of a course of treatment and the return of tinnitus. Follow-up assessment will be conducted at 3 months to evaluate change in the primary outcome measures and in the baseline assessments of clinical, behavioral, emotional, and perceptual aspects of tinnitus related to quality of life. Analyses will compare change scores from baseline on the primary outcome measures between standard and active maintenance treatment and between active and sham maintenance treatment. Attrition and missing data will be treated with subject replacement. This project is significant because it has potential to produce a treatment that decreases tinnitus perception chronically. Our innovative approach of using maintenance rTMS can shift current paradigms and models of how rTMS is applied in other clinical disorders treated with rTMS. We expect maintenance rTMS to benefit half of patients with tinnitus. We anticipate that these findings will support larger, multisite trials that can establish rTMS as a frst line treatment approach for tinnitus and gain FDA approval for this use.
描述(由申请人提供):主观耳鸣是在没有外部刺激的情况下感觉到像铃声,嗡嗡声或嘶嘶声的声音。耳鸣是一种严重的神经系统疾病,影响着5100万美国公民。没有解药。1200万患者因睡眠、情绪和注意力障碍而寻求治疗,300万人无法工作。目前的治疗方法实际上很少减少耳鸣的感觉。相比之下,重复经颅磁刺激(rTMS)是一种非侵入性的局部脑刺激方法,可以显着减少50%的患者的主观耳鸣;然而,治疗效果是暂时的,在为期一周的标准治疗后持续1至2周。我们的初步工作表明,这种限制可以通过改变rTMS的应用方式来克服。我们已经观察到,rTMS对耳鸣的作用在对标准治疗过程有积极反应的人中是非常可靠的(即,治疗响应者)以及当耳鸣恢复时重新应用rTMS(即,维持治疗)产生随时间持续的附加益处。我们假设维持rTMS通过逆转由正常感觉输入的丧失(即,丘脑皮质节律障碍),我们将在治疗前后使用高密度EEG记录来检验这一假设。我们期望维持治疗能以一种加性的方式改善耳鸣,并且相对于标准治疗和假治疗对照,它能阻止复发。我们将采用治疗交叉的设盲研究设计,将研究重点放在30名治疗应答者身上,这些应答者将接受假手术和活性维持rTMS。将对30名无应答者进行研究,以了解哪些患者特征可预测治疗应答。维持治疗将包括4个3天的rTMS疗程,间隔3周。主要结果测量将包括耳鸣严重程度的问卷、耳鸣响度和烦恼的视觉模拟评级、改善/恶化的强制选择测量、耳鸣频率和响度的物理锚定测量以及EEG频带的频谱功率和相干性。维持治疗效果的时间和持续时间将通过计算疗程结束和耳鸣恢复之间的天数来评估。随访评估将在3个月时进行,以评估主要结局指标的变化以及与生活质量相关的耳鸣的临床、行为、情绪和感知方面的基线评估。分析将比较标准和活性维持治疗之间以及活性和假维持治疗之间主要结局指标较基线的变化评分。缺失和缺失数据将通过受试者替换进行处理。这个项目是重要的,因为它有可能产生一种治疗,减少耳鸣的感知慢性。我们使用维持rTMS的创新方法可以改变目前rTMS如何应用于其他rTMS治疗的临床疾病的范式和模型。我们希望维持rTMS能使一半的耳鸣患者受益。我们预计,这些发现将支持更大的,多站点的试验,可以建立rTMS作为耳鸣的第一线治疗方法,并获得FDA批准用于此用途。

项目成果

期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Methodological aspects of clinical trials in tinnitus: a proposal for an international standard.
  • DOI:
    10.1016/j.jpsychores.2012.05.002
  • 发表时间:
    2012-08
  • 期刊:
  • 影响因子:
    4.7
  • 作者:
    Landgrebe, Michael;Azevedo, Andreia;Baguley, David;Bauer, Carol;Cacace, Anthony;Coelho, Claudia;Dornhoffer, John;Figueiredo, Ricardo;Flor, Herta;Hajak, Goeran;van de Heyning, Paul;Hiller, Wolfgang;Khedr, Eman;Kleinjung, Tobias;Koller, Michael;Lainez, Jose Miguel;Londero, Alain;Martin, William H.;Mennemeier, Mark;Piccirillo, Jay;De Ridder, Dirk;Rupprecht, Rainer;Searchfield, Grant;Vanneste, Sven;Zeman, Florian;Langguth, Berthold
  • 通讯作者:
    Langguth, Berthold
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MARK S MENNEMEIER其他文献

MARK S MENNEMEIER的其他文献

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{{ truncateString('MARK S MENNEMEIER', 18)}}的其他基金

Maintenace rTMS for chronic tinnitus relief
维持 rTMS 以缓解慢性耳鸣
  • 批准号:
    8300413
  • 财政年份:
    2012
  • 资助金额:
    $ 14.01万
  • 项目类别:
Identifying and Treating Arousal-Related Deficits in Neglect and Dysphagia
识别和治疗忽视和吞咽困难中与唤醒相关的缺陷
  • 批准号:
    7878601
  • 财政年份:
    2009
  • 资助金额:
    $ 14.01万
  • 项目类别:
Identifying and Treating Arousal-Related Deficits in Neglect and Dysphagia
识别和治疗忽视和吞咽困难中与唤醒相关的缺陷
  • 批准号:
    7588624
  • 财政年份:
    2009
  • 资助金额:
    $ 14.01万
  • 项目类别:
Rehabilitating Strength Perception After Stroke
中风后恢复力量感知
  • 批准号:
    7595093
  • 财政年份:
    2008
  • 资助金额:
    $ 14.01万
  • 项目类别:
Neglect and Neural Mechanisms of Magnitude Estimation
幅度估计的忽视和神经机制
  • 批准号:
    6331744
  • 财政年份:
    2001
  • 资助金额:
    $ 14.01万
  • 项目类别:
NEW CONCEPTS AND TREATMENT FOR SPATIAL NEGLECT
空间忽视的新概念和治疗方法
  • 批准号:
    6322216
  • 财政年份:
    2001
  • 资助金额:
    $ 14.01万
  • 项目类别:
NEW CONCEPTS AND TREATMENT FOR SPATIAL NEGLECT
空间忽视的新概念和治疗方法
  • 批准号:
    6536367
  • 财政年份:
    2001
  • 资助金额:
    $ 14.01万
  • 项目类别:
Neglect and Neural Mechanisms of Magnitude Estimation
幅度估计的忽视和神经机制
  • 批准号:
    6540190
  • 财政年份:
    2001
  • 资助金额:
    $ 14.01万
  • 项目类别:
Neglect and Neural Mechanisms of Magnitude Estimation
幅度估计的忽视和神经机制
  • 批准号:
    6747646
  • 财政年份:
    2001
  • 资助金额:
    $ 14.01万
  • 项目类别:
Neglect and Neural Mechanisms of Magnitude Estimation
幅度估计的忽视和神经机制
  • 批准号:
    6925058
  • 财政年份:
    2001
  • 资助金额:
    $ 14.01万
  • 项目类别:

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