The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Changes in Tinnitus Handicap Inventory (THI) scores for short-term efficacy assessment
研究概览
简要总结
This clinical study is prospective, single-center, randomized, controlled, double-blind clinical trail, which entitled transcranial electrical stimulation for the treatment of acute tinnitus approved by Sun Yat-sen University, and intends to recruit 86 patients with sudden deafness and tinnitus. For acute subjective tinnitus, a common otological disease, the study gave the experimental group patients received tDCS with electrodes positioned over the left temporal cortex for 5 days. To assess the efficacy of conventional medical therapy and tDCS by comparing changes in anterior and posterior tinnitus-related subjective scale scores, such as THI, VAS, BAI, BDI, PSQI, and hearing recovery, in patients who received tDCS, to determine whether tDCS is effective in improving acute tinnitus, and whether it is superior to conventional tinnitus treatment. In addition, the study will continue to follow patients for 1 month,3 months, and 6 months after the end of treatment to observe the long-term sustained efficacy of tDCS. This clinical trail will also evaluate tDCS from the perspective of compliance and safety, and explore the factors affecting the efficacy of this therapy.
详细描述
Sample size estimation:
On-site recruitment will be conducted in the otolaryngology clinic for eligible patients with sudden deafness and tinnitus, with dedicated personnel to recruit subjects, with a total of at least 86 expected recruitment. In order to retain subjects, staff will tell them about the benefits of inclusion in clinical studies for sudden deafness with tinnitus, and actively add subjects' contact information to provide relevant consulting services for subjects during clinical studies. During follow-up, participants will be provided with a free tinnitus-related assessment test to motivate.
Plan for missing data： Screening failure, i.e. subjects did not meet the inclusion and exclusion criteria, or subjects withdrew informed consent, among other things for reasons why it was not included in this clinical study. Study subjects who failed to screen will be pressed according to their own condition Provide appropriate treatment according to clinical guidelines. This subset of subjects will not be included in clinical studies.
Statistical analysis plan:
When considering the influence of baseline, the continuous variables were analyzed by covariance analysis, and the qualitative indicators were tested by CMH test or logistic regression.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In the whole clinical research process, the subjects and researchers participating in the efficacy and safety evaluation should be in a blind state, that is, neither of them knows the specific intervention measures given to the subjects. For participant, the treatment equipment is exactly the same between the two groups. Also, 10 seconds sham stimulation at the beginning of treatment is set in the control group for minimizing risk of participants being able to guess treatment allocation. The randomized allocation is completed by a unified randomization center. Therefore, the investigators in each center just know "A" or "B" for the allocation information of each participant. For outcomes assessors, they are only responsible for baseline and follow-up assessment during the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with tinnitus as the main complaint: patients subjectively feel sound in the ear or deep part of the head without internal or external sound stimulation, with or without hearing loss, and seek medical treatment
- •Patients with sudden deafness with tinnitus whose course is less than 1 month and have not received any drug treatment
- •Age 18-60 years
- •Tinnitus frequency is 125-8000 Hz
排除标准
- •Patients with conductive deafness, history of middle ear surgery, pulsatile tinnitus caused by vascular aberration and tinnitus cause by Meniere disease
- •History of head trauma, central nervous system disease, mental disease, and drug abuse
研究组 & 干预措施
Receive traditional medical therapy and transcranial direct current stimulation
intravenous methylprednisolone infusion (dose of 1 mg/kg/day, maximum 60 mg/day) for 5 to 10 days. Patients included in this study were routinely examined and tested for audiometry, including otoscopy, pure tone audiometry, acoustic impedance, brainstem evoked potential, and tinnitus detection. After completion, the 32-guide EEG collector from Bricon was used to collect changes in neural activity in all subjects.
干预措施: Receive traditional medical therapy and transcranial direct current stimulation (Device)
Receive traditional medical therapy and sham stimulation
Similarly, intravenous methylprednisolone infusion (dose of 1 mg/kg/day, maximum 60 mg/day) for 5 to 10 days. By controlling the tDCS stimulator to mimic only the first 30 seconds of tDCS stimulation, after 30 seconds of pathway resistance control, so that the stimulation intensity is below the threshold, without giving real stimulation, in this process, the position of the stimulation target is not changed, and the rest of the operation is the same.
干预措施: Receive traditional medical therapy and sham stimulation (Device)
结局指标
主要结局
Changes in Tinnitus Handicap Inventory (THI) scores for short-term efficacy assessment
时间窗: From baseline to after 5 days treatment
Difference in the change of THI scores between two groups after 5 days treatment. The THI evaluates the severity of tinnitus in terms of emotion and function. The global scores of THI range from 0 (no disability) to 100 (serve disability).
次要结局
- Changes in scores of Visual Analog Scale (VAS) for short-term efficacy assessment(From baseline to after 5 days treatment)
- Changes in scores of Pittsburgh sleep quality index (PSQI) for short-term efficacy assessment(From baseline to after 5 days treatment)
- Changes of Beck Anxiety Inventory (BAI) scores in the two groups for long-term efficacy assessment(From 1-month follow-up visit to 6-month follow-up visit)
- Changes in scores of Beck Depression Inventory (BDI) for short-term efficacy assessment(From baseline to after 5 days treatment)
- Changes of Beck Depression Inventory (BDI) scores in the two groups for long-term efficacy assessment(From 1-month follow-up visit to 6-month follow-up visit)
- The difference of functional connectivity based on resting state electroencephalogram (EEG) between the two groups(From 1-month follow-up visit to 6-month follow-up visit)
- Changes of Tinnitus Handicap Inventory (THI) scores in the two groups for long-term efficacy assessment(From 1-month follow-up visit to 6-month follow-up visit)
- Changes of Visual Analog Scale (VAS) scores in the two groups for long-term efficacy assessment(From 1-month follow-up visit to 6-month follow-up visit)
- Changes in scores of Beck Anxiety Inventory (BAI) for short-term efficacy assessment(From baseline to after 5 days treatment)
- Changes of Pittsburgh sleep quality index (PSQI) scores in the two groups for long-term efficacy assessment(From 1-month follow-up visit to 6-month follow-up visit)
- The effective rate of relieving sudden deafness with tinnitus in the two groups(From baseline to after 5 days treatment)
- The difference of effective connectivity based on functional magnetic resonance imaging (fMRI) between the two groups(From 1-month follow-up visit to 6-month follow-up visit)
- The difference of effective connectivity based on resting state electroencephalogram (EEG) between the two groups(From 1-month follow-up visit to 6-month follow-up visit)
- The difference of functional connectivity based on functional magnetic resonance imaging (fMRI) between the two groups(From 1-month follow-up visit to 6-month follow-up visit)