Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12)
研究概览
简要总结
Stimulation of the left and right auditory cortex with daily transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.
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 neural pathways and the central auditory system. These changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. Preliminary data presented on international conferences suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. High-frequency (hf; 100-650Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily Hf-tRNS (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm 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
- •Diagnosis: Duration of tinnitus more than 6 months
排除标准
- •Objective tinnitus
- •Irregular head shap below the electrodes
- •Eczema on the head
- •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
研究组 & 干预措施
Transcranial random noise stimulation (tRNS)
High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4
干预措施: Transcranial random noise stimulation (tRNS) (Device)
结局指标
主要结局
Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12)
时间窗: Week 12
次要结局
- Change of depressive symptoms as measured by the Major Depression Inventory(Week 12)
- Change in quality of life as measured by the WHOQoL-Bref(Week 12)
- Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales(Week 12)
- Change of tinnitus severity as measured by the Tinnitus Questionnaire(Week 12)
- Change of depressive symptoms as measured by the Major Depression Inventory(Week 4)
- Change in quality of life as measured by the WHOQoL-Bref(Week 2)
- Change of tinnitus severity as measured by the Tinnitus Questionnaire(Week 2)
- Change of tinnitus severity as measured by the Tinnitus Questionnaire(Week 4)
- Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales(Week 2)
- Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales(Week 4)
- Change of depressive symptoms as measured by the Major Depression Inventory(Week 2)
- Change in quality of life as measured by the WHOQoL-Bref(Week 4)
研究者
Berthold Langguth, MD, Ph.D.
M.D., Ph.D.
University of Regensburg