Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Combination With Relaxation Therapy in Patients With Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)
研究概览
简要总结
Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress of phantom sounds.
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. One significant modulator of tinnitus is stress. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. Also non-auditory cortical areas of attention allocation and emotional processing was shown to be involved. Treatment remains difficult. The most effective treatment in chronic tinnitus is cognitive behavioral therapy including elements of relaxation therapy. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporoparietal areas and high-frequency rTMS applied to the left frontal cortex. Newer findings indicate that exercise-combined non-invasive brain stimulation might show superior effects in contrast to rTMS or exercise alone. Combination of relaxation and two-sided (frontal and temporo-parietal) rTMS will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a pilot trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bothersome, subjective chronic tinnitus
- •Duration of tinnitus more than 6 months
排除标准
- •Objective tinnitus
- •Treatable cause of the tinnitus
- •Involvement in other treatments for tinnitus at the same time
- •Clinically relevant psychiatric comorbidity
- •Clinically relevant unstable internal or neurological comorbidity
- •History of or evidence of significant brain malformation or neoplasm, head injury
- •Cerebral vascular events
- •Neurodegenerative disorder affecting the brain or prior brain surgery
- •Metal objects in and around body that can not be removed
- •Pregnancy
- •Alcohol or drug abuse
- •Prior treatment with TMS
结局指标
主要结局
Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)
时间窗: Week 12
次要结局
- Change of tinnitus severity as measured by the Tinnitus Severity Scale(Week 12)
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI)(Week 2)
- Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)(Week 12)
- Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)(Week 12)
- Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)(Week 4)
- Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller(Week 12)
研究者
Berthold Langguth, MD, Ph.D.
MD, PhD
University of Regensburg