The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Tinnitus Functional Index (TFI)
研究概览
简要总结
The aim of this study is to evaluate the added effect of tDCS to TRT within patients with chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of therapy, at the end of the counselling and at last a follow-up visit will be planned after 84 days of the start of the therapy. Subjective outcome measurements such as Tinnitus Functional Index and Visual Analogue Scales of loudness are the primary outcome measurement. Secondary outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis questionnaire and psychoacoustic measurements.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of tinnitus > 6 months
- •Maximum loudness of tinnitus on the VAS ≥ 4
- •TFI score ≥ 25
排除标准
- •Pregnancy
- •Psychiatric disorders
- •Pace maker or defibrillator
- •Pulsatile tinnitus
- •Acoustic Neurinoma
结局指标
主要结局
Tinnitus Functional Index (TFI)
时间窗: 3 months
次要结局
- Late Latency Evoked Potentials(3 months)
- Psychoacoustic measurements(3 months)
- Visual Analogue Scale of Loudness(3 months)
- Hyperacusis Questionnaire(3 months)
- Hospital Anxiety and depression Scale(3 months)
- Patient Global Impression of Change(3 months)
研究者
Ethisch Comité UZA
Prof.
University Hospital, Antwerp