Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
研究概览
详细说明
Tinnitus is a subjective auditory perception of sounds or noise not triggered by external auditory stimuli, affecting millions of people worldwide. To date, pharmacological and physical/ behavioural treatments in severe cases are generally unsatisfactory. Functional brain imaging changes associated with tinnitus include hyperactivity of discrete temporoparietal regions, including both the primary auditory cortex (AC) and the secondary, or associative cortex. High-frequency rTMS (10 Hz or more) applied on the scalp overlying the hyperactive left AC produced an intense tinnitus attenuation.
Repetitive TMS consists of 1000 stimulations/ day at 1 Hz and 110% of the motor threshold, for five consecutive days over the left AC. A high number of stimuli/day were applied because of the previously suggested dose dependency of tinnitus alleviation by rTMS. Furthermore, the use of such relatively high intensity assured the stimulation of most of the target region, even in the case of mismatch between the scalp position and the underlying anatomy, which can be expected using the International EEG system as anatomical reference for TMS stimulation.
Upon recruitment, all patients will undergo a 1 week treatment consisting of 5 rTMS sessions. Tinnitus rating will be performed weekly.
Tinnitus is rated by a 0-100 Visual Analogue Scale (VAS), where 0 is wellness and 100 the worst possible tinnitus related discomfort. In addition, our validated Tinnitus Inventory scoring will be administered. Audiometry and otoscopy will be performed at enrolment and at the end of the study. Tinnitus, and acoustic evaluations are then collected by experimenters blind to the type of rTMS applied.
Standard statistical methods (SPSS for Windows) will be used to perform comparisons.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Outram Road
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Singapore、Outram Road、新加坡、169608
- 招聘中
- Singapore General Hospital
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接触:
- YL Lo, MD
- 邮箱:lo.yew.long@sgh.com.sg
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首席研究员:
- YL Lo, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients with tinnitus
Exclusion Criteria:
- Patients with contraindications to TMS: pacemaker, intracranial surgery, implants and seizures
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS)
大体时间:Baseline, 1,2,3 & 4weeks after treatment
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THI and VAS is measure before the treatment and weekly for 4 weeks after the treatment.
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Baseline, 1,2,3 & 4weeks after treatment
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合作者和调查者
调查人员
- 首席研究员:YL Lo, MD、National Neuroscience Institute, Singapore General Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.