Variable Changes in Continuous Resting EEG(Electroencephalography) and Auditory ERP(Event-related Potential) Before and After Transcranial Magnetic Stimulation Treatment; Double Blind Randomized Controll Trails
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change of Tinnitus Handicap Inventory (THI) before and after treatment , difference in brain gating and connectivity before and after treatment.
研究概览
简要总结
Investigation of objective tinnitus diagnosis method through measurement of continuous resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation (rTMS) treatment of tinnitus.
详细描述
Tinnitus is defined as the subjective perception of a sound in the absence of any physical sound. Therefore, accurate diagnosis of tinnitus is so difficult.
So, Investigators measure auditory ERP through autonomously developed system to make a objective diagnosis tinnitus. Moreover, patients undergo continuous resting EEG measurement.
In this study investigators examined the efficacy of rTMS treatment for tinnitus and check into changes in brain connectivity or auditory task with ERP, continuous resting EEG before and after rTMS. And develop a new test that can detect tinnitus objectively in humans, using the prepulse gap paradigm
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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 chronic tinnitus
- •Chronic subjective tinnitus for more than 6 months
- •Subject is naive regarding rTMS
- •Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study
- •Stable enough to complete this study per the opinion of the Study Physician
- •No restrictions, provided the dosages have been in place for at least 3 months
- •A three month washout from any other tinnitus treatment or management program is required prior to entering this study.
排除标准
- •Objective tinnitus or tinnitus with treatable cause
- •Presence of intracranial or intraocular ferromagnetic materiel or particles
- •Cardiac pacemaker or other electronic implants (including cochlear implant) Serious heart disease or other unstable major medical condition
- •Personal history of central nervous system disorder, head injury, stroke or seizures
- •Familial history of epilepsy
- •Concomitant medication with antidepressants and antipsychotics
- •Pregnant women
- •Others known contraindications to rTMS or brain MRI
研究组 & 干预措施
Active rTMS(A)
low frequency frontal and temporal repetitive transcranial magnetic stimulation
干预措施: Active rTMS(A) (Device)
Active rTMS(B)
Temporal low frequency repetitive transcranial magnetic stimulation
干预措施: Active rTMS(B) (Device)
Sham condition(C)
low frequency frontal and temporal repetitive transcranial magnetic stimulation
干预措施: Sham condition(C) (Device)
结局指标
主要结局
Change of Tinnitus Handicap Inventory (THI) before and after treatment , difference in brain gating and connectivity before and after treatment.
时间窗: Change from Baseline THI at 6 months
次要结局
- Positive And Negative Affect Schedule(PANAS)(Baseline, 1, 2 and 3 month after the first intervention)
- State-Trait Anxiety Inventory (STAI)(Baseline)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline)
- Beck's Depression Inventory (BDI)(Baseline)
- Change of Visual Analogue Scale (VAS) for tinnitus states before and after treatment.(Change from Baseline VAS at 6 months)