Effectiveness of Low Frequency Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
研究概览
简要总结
Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.
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. Treatment is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by low frequency rTMS of the right dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether low frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of subjective chronic tinnitus
- •Duration of tinnitus more than 3 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
研究组 & 干预措施
Temporal low frequency rTMS
temporal low frequency rTMS of auditory cortex
干预措施: Temporal low frequency rTMS (Device)
Combined frontal and temporal rTMS
Combined low frequency frontal and temporal transcranial magnetic stimulation of auditory cortex and right DLPFC
干预措施: Combined frontal and temporal rTMS (Device)
结局指标
主要结局
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
时间窗: Baseline, Day 12
次要结局
- Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12(Baseline vs. all follow-up visits)
- Change of depressive symptoms as measured by the Beck Depression Inventory (BDI)(Baseline vs. all follow-up visits)
- Change in quality of life as measured by the WHOQoL(Baseline vs. all follow-up visits)
研究者
Berthold Langguth, MD, Ph.D.
MD, Ph.D.
University of Regensburg