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临床试验/NCT02653547
NCT02653547已完成不适用

Influence of Treatment Duration and Stimulation Frequency on Repetitive Transcranial Magnetic Stimulation in Chronic Tinnitus

University of Regensburg1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
change in tinnitus questionnaire

研究概览

简要总结

Patients receive two weeks of treatment (prefrontal high-frequency and bilateral low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After two weeks of treatment they can decide if they want to quit the treatment or if they want to proceed with the treatment for another two weeks.

详细描述

Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory and non-auditory neural pathways. Low-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus based on the rationale to reduce increased activity of the auditory system. Furthermore, high-frequency stimulation of the left frontal cortex was added to this standard treatment based on rTMS studies in affective disorders and the association of tinnitus distress with depressivity. Thus, high-frequency stimulation of the left prefrontal cortex and low-frequency stimulation of bilateral temporoparietal cortex was introduced as new treatment scheme in chronic tinnitus (multisite standard).

Additionally, there is also evidence that high-frequency stimulation of the temporoparietal cortex is effective in chronic tinnitus. Furthermore, standard treatment in chronic tinnitus is two weeks (ten treatment days) which is shorter than the standard in rTMS in affective disorders. Thus, the aim of the present trial is to investigate the influence of high-frequency stimulation of the temporoparietal cortex and of increasing the number of treatment days.

Patients receive two weeks of treatment (prefrontal high-frequency and bilateral low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After two weeks of treatment they can decide if they want to quit the treatment or if they want to proceed with the treatment for another two weeks.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •written informed consent
  • •duration of tinnitus more than 6 months
  • •bothersome chronic tinnitus

排除标准

  • •not stable internal, mental, and neurological diseases
  • •contraindication for rTMS (pacemaker, metal implants, pregnancy, epilepsy, status post severe craniocerebral injury )
  • •uninvolvement in other treatment studies for tinnitus at the same time

研究组 & 干预措施

standard multisite four weeks

Experimental

Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks

干预措施: standard multisite four weeks (Other)

high-frequency multisite four weeks

Experimental

Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks

干预措施: high-frequency multisite four weeks (Other)

standard multisite two weeks

Experimental

Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks

干预措施: standard multisite two weeks (Other)

high-frequency multisite two weeks

Experimental

Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks

干预措施: high-frequency multisite two weeks (Other)

结局指标

主要结局

change in tinnitus questionnaire

时间窗: week12

change in tinnitus questionnaire

次要结局

  • change in tinnitus handicap inventory(week2, week3, week4, week12)
  • change in tinnitus numeric rating scales(week2, week3, week4, week12)
  • change in major depression inventory(week2, week3, week4, week12)
  • change in clinical global impression(week2, week3, week4, week12)
  • change in quality of life(week2, week3, week4, week12)
  • change in tinnitus questionnaire(week2, week3, week4, week12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berthold Langguth, MD, Ph.D.

M.D., Ph.D.

University of Regensburg

研究点 (1)

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