Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 7
- 主要终点
- Change in tinnitus questionnaire total score (contrast baseline (-day 3) versus end of treatment (day 10))
研究概览
简要总结
Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to modulate auditory cortex activity and plasticity contributing to the perception and distress of chronic tinnitus.
详细描述
Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. One significant modulator of tinnitus is stress. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporal and temporoparietal areas. Continuous theta burst stimulation (cTBS) is a new protocol of rTMS with a possible superior effect in contrast to low-frequency rTMS. Also anatomical neuronavigation might increase the efficacy of rTMS due to exact targeting of the primary auditory cortex. Thus, the aim of this study is the evaluation of the clinical efficacy of neuronavigated left-sided cTBS in chronic tinnitus in a randomised sham-controlled two-arm design.
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
- None
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 bothersome, subjective chronic tinnitus
- •Duration of tinnitus more than 6 months
排除标准
- •Objective tinnitus
- •Treatable cause of the tinnitus
- •Involvement in other treatments for tinnitus at the same time
- •Clinically relevant psychiatric comorbidity
- •Clinically relevant unstable internal or neurological comorbidity
- •History of or evidence of significant brain malformation or neoplasm, head injury
- •Cerebral vascular events
- •Neurodegenerative disorder affecting the brain or prior brain surgery
- •Metal objects in and around body that can not be removed
- •Pregnancy
- •Alcohol or drug abuse
- •acute or chronic inflammation of the middle ear, Meniere diseases, sudden idiopathic hearing loss, fluctuating hearing
- •history of seizures
研究组 & 干预措施
Left temporal verum cTBS
Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session)
Intervention: Left temporal verum cTBS
干预措施: Left temporal verum cTBS (Device)
Left temporal placebo cTBS
Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings
Intervention: Left temporal placebo cTBS
干预措施: Left temporal placebo cTBS (Device)
结局指标
主要结局
Change in tinnitus questionnaire total score (contrast baseline (-day 3) versus end of treatment (day 10))
时间窗: -day 3; day 10
次要结局
- Change of tinnitus questionaire total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))(-week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8)
- Change of depressive symptoms as measured by the Beck Depression Inventory II (BDI) (baseline visit -week 2 vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))(-week 2; day 6; day 10; week 1; week 3; week 8)
- Change of tinnitus handicap inventory total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))(-week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8)
- Change of tinnitus numeric rating scales (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))(-week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8)
研究者
Berthold Langguth, MD, Ph.D.
MD, PhD
University of Regensburg