NCT01874444Unknown不适用
Verify the Effectiveness rTMS Using MEG
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in MEG Asymmetry Index and amplitude of the auditory area
研究概览
简要总结
The purpose of this study is to determine whether rTMS are effective in the treatment of tinnitus
详细描述
Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. We aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness. Linked to a neuronavigation system that is guided by magnetic resonance imaging (MRI) of the frontal and temporal, rTMS can suppress areas of cortical plasticity. This cortical reorganization can be demonstrated by magnetoencephalography (MEG)
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
- •Pure tone average <50 dB HL in the ear where tinnitus is perceived
- •Dominant tinnitus frequency measured between 4 and 8 kHz
- •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
- •Absolute thresholds > 60 dB on individual frequencies up to 8 kHz
- •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
- •Severe depression
- •Severe anxiety
- •Others known contraindications to rTMS or brain MRI
结局指标
主要结局
Change in MEG Asymmetry Index and amplitude of the auditory area
时间窗: Baseline, After active treatment week
次要结局
- State-Trait Anxiety Inventory (STAI)(Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention)
- Tinnitus Handicap Inventory (THI)(Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention)
- Visual Analog Scales (VAS)(Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention)
- Beck Depression Inventory (BDI)(Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention)
研究者
研究点 (1)
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