Verification of the Usefulness of the Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Tinnitus
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 severity as measured by the Tinnitus Handicap Inventory (THI)
研究概览
简要总结
Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus
详细描述
Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. The investigators aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.
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 rTMS1
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex
干预措施: Active rTMS 1 (Device)
Active rTMS2
Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex
干预措施: Active rTMS 2 (Device)
Active rTMS3
Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex
干预措施: Active rTMS 3 (Device)
Sham Condition
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex
干预措施: sham condition (Device)
结局指标
主要结局
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
时间窗: Change from Baseline inTinnitus Handicap Inventory at 3 months
次要结局
- State-Trait Anxiety Inventory (STAI)(Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention)
- Beck's Depression Inventory (BDI)(Baseline, before and after each intervention, 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 analogue scale (VAS)(Baseline, day 7, day 14, 1, 2 and 3 months after the first intervention)