Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change of tinnitus severity as measured by the tinnitus questionnaire
研究概览
简要总结
Magnetic stimulation of the brain (repetitive transcranial magnetic stimulation) and of neck muscles (repetitive peripheral muscle stimulation) is used to alter tinnitus-related cortical activity and neck muscles tension.
详细描述
Chronic tinnitus is characterized by several comorbid disorders. One of them is neck and back pain. Here, we investigate the feasibility, safety and clinical efficacy of the combination of repetitive transcranial magnetic stimulation (rTMS) and peripheral muscle stimulation (rPMS) in chronic tinnitus in a pilot study. rTMS is considered to interact with neural tinnitus networks. rPMS is suggested to bring relief to muscle tension. This is an one arm study where explorative analyses will be done with special consideration on patients suffering from neck pain in the analysis.
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 80 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
- •Acute neck or back pain
- •Neck or back pain of unknown etiology
- •Implants in the neck or back, that are sensitive to magnetic fields
结局指标
主要结局
Change of tinnitus severity as measured by the tinnitus questionnaire
时间窗: week 12
次要结局
- Change in quality of life as measured by the WHOQoL-Bref(week 2, week 4, week 12)
- Change in neck pain by the neck pain and disability scale(week 2, week 4, week 12)
- Change of tinnitus severity as measured by the tinnitus questionnaire(week 2, week 4, week 12)
- Change of tinnitus severity as measured by numeric rating scales(week 2, week 4, week 12)
- Change of depressive symptoms as measured by the major depression inventory(week 2, week 4, week 12)
研究者
Berthold Langguth, MD, Ph.D.
MD, PhD
University of Regensburg