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临床试验/NCT01929837
NCT01929837已完成不适用

Treatment of Tinnitus With Transcranial Magnetic Stimulation

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
The change of loudness and pitch of the tinnitus is psychophysically measured, VAS questionnaires, Tinnitus Handicap Inventory, Tinnitus diary

研究概览

简要总结

Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus affects approximately 10-15 % of the population. The prevalence increases with age and it is estimated that more than 20 % of the older people have tinnitus. Approximately 10-15 % of tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety, depression and sleep disturbances. The treatment of chronic tinnitus is difficult and most therapies focus on alleviating the condition rather than treating the cause. Pathophysiology of tinnitus still remains incompletely understood. Functional brain imaging data in tinnitus patients and animal models suggest that tinnitus is associated with increased neuronal activity, increased synchronicity, and functional reorganization within the auditory cortex either uni- or bilaterally, but there are also functional alterations in brain areas outside the auditory system. Transcranial magnetic stimulation (TMS) is a neuromodulation technique based on the principle of electromagnetic induction of an electric field in the brain by means of magnetic pulses given to the scalp. TMS is a non-invasive, painless, and safe method for modulation of cortical activity. TMS pulses given at low frequencies (≤ 1 Hz) have been shown to decrease cortical excitability both in experimental settings and humans, which forms the basis for using low frequency rTMS to treat chronic tinnitus patients, in whom hyperactivity of the auditory cortex has been observed in functional brain imaging studies

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic tinnitus 6 months-10 years
  • age 18-65 years
  • tinnitus intensity VAS at least 4/10

排除标准

  • pulsatile tinnitus
  • objective tinnitus
  • epilepsy, brain disease
  • severe/recent heart disease
  • pregnancy
  • alcohol abuse
  • metallic implants etc.

结局指标

主要结局

The change of loudness and pitch of the tinnitus is psychophysically measured, VAS questionnaires, Tinnitus Handicap Inventory, Tinnitus diary

时间窗: Change from baseline and 2-3 days after treatment period

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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