Transcranial Direct Current Stimulation (tDCS) for Tinnitus - Effects of Multiple Treatment Sessions: a Randomised-controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proof of concept
研究概览
简要总结
Tinnitus - the awareness of sound without any outside source - affects around 15% of people and can cause anxiety and depression. Treatment options are limited and do not address tinnitus directly (e.g., reduce its loudness). To do that, we must change brain activity causing tinnitus. Low-dose electrical stimulation, using a technique called transcranial Direct Current Stimulation (tDCS), is a promising approach. The technique is safe and easy to administer. Several small studies have tested tDCS for tinnitus showing some benefits.
To assess whether these benefits will generalise to other patients, we need to conduct a randomised controlled trial - a large, rigorously controlled experiment based on prior agreed procedures. Clinical trials are expensive and time-consuming to run and thus require meticulous pilot work to establish the most effective treatment regimens and the most sensitive measures of treatment outcome. The current study aims to provide such pilot information for a clinical trial of tDCS treatment of tinnitus. Using a total of 40 patients, we will establish how to best to administer tDCS and measure resulting changes in tinnitus perception and associated brain activity.
The current study is a crucial first step towards determining whether or not tDCS can effectively treat tinnitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Statistician
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
- •Aged 18 or over
- •Suffering from subjective idiopathic tinnitus
- •Sufficient understanding of English to be able to provide informed consent
- •Able to safely undergo tDCS
排除标准
- •Aged under 18
- •Not suffering from tinnitus or suffering from objective tinnitus
- •Insufficient understanding of English to be able to provide informed consent
- •Unable to safely undergo tDCS as assessed by tDCS Safety Questionnaire
- •Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
研究组 & 干预措施
Transcranial Direct Current Stimulation (tDCS)
TDCS will be delivered using a NeuroConn DC Stimulator Plus via two 35cm2 rubber electrodes covered in saline-soaked sponges. The anode electrode will be positioned over EEG 10-20 coordinate F4 and the cathode over F3. The current will be delivered at 2mA for 20 minutes with ramp-up and ramp-down of 10 seconds. Each participant will receive 10 daily stimulation sessions over 2 weeks.
干预措施: transcranial Direct Current Stimulation (Device)
Sham
Same as intervention arm but the current will be delivered at 2mA for 30 seconds, after which the stimulation will be discontinued.
干预措施: transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Proof of concept
时间窗: Assessed at study end (anticipated as 1 year after study start)
Measured by protocol compliance and attrition
次要结局
- Tinnitus symptom severity(Before first intervention session, after final intervention session and at 3-month follow-up)
- Tinnitus loudness(Before first intervention session, after each intervention session and at 3-month follow-up (VAS). Before first intervention session and after final intervention session (loudness matching))
- Depression(Before first intervention session, after final intervention session and at 3-month follow-up)
- Anxiety(Before first intervention session, after final intervention session and at 3-month follow-up)
- Treatment satisfaction(After final intervention session and at 3-month follow-up)
- Adverse effects(After each intervention session (10 sessions over 2 weeks))
- Electrophysiological brain activity(Before first intervention session and after final intervention session (1st and 10th of 10 sessions over 2 weeks)..)
研究者
Magdalena Sereda
Assistant Professor
University of Nottingham