Effect of Time Shift of Transcranial Direct Current Stimulation (tDCS) for Treatment of Acute Tinnitus
试验速览
- 阶段
- 不适用
- 试验地点
- 1
- 主要终点
- Improvement of tinnitus
研究概览
简要总结
The treatment for patients with acute tinnitus consists of Methylprednisolone and hyperbaric oxygen therapy. For this study transcranial direct current stimulation (tDCS) was added to the protocol. The purpose is to determine the effect of the time shift of tDCS. Two conditions will be compared: tDCS simultaneously with the hyperbaric oxygen therapy or tDCS 3 weeks after the start of the tinnitus.
An audiological testing will be performed at the day of admission, after 3 weeks, 6 weeks and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 50 years
- •presence of acute tinnitus or worsening of tinnitus caused by otogenic disease
- •registration in UZA within 48 hours after start tinnitus
- •VAS-score ≥ 4
- •ability to understand and sign informed consent
排除标准
- •history of epileptic seizures
- •severe organic comorbidity
- •psychiatric disorders or a history of psychiatric disorders with psychotic symptoms
- •Pace maker
- •pregnancy
研究组 & 干预措施
tDCS simultaneously with hyperbaric oxygen therapy
干预措施: transcranial direct current stimulation (tDCS) (Other)
tDCS 3 weeks after start tinnitus
干预措施: transcranial direct current stimulation (tDCS) (Other)
结局指标
主要结局
Improvement of tinnitus
时间窗: 12 weeks
Tinnitus Questionnaire, Visual Analog Scale, Beck Depression Index, Hyperacusis questionnaire
次要结局
- Hearing(12 weeks)
研究者
Ethisch Comité UZ Antwerpen
Sarah Rabau
University Hospital, Antwerp