Landgrebe Michael, Binder Harald, Koller Michael, Eberl Yvonne, Kleinjung Tobias, Eichhammer Peter, Graf Erika, Hajak Goeran, Langguth Berthold
Department of Psychiatry, Psychosomatics, and Psychotherapy, University of Regensburg, Germany.
BMC Psychiatry. 2008 Apr 15;8:23. doi: 10.1186/1471-244X-8-23.
Chronic tinnitus is a frequent condition, which can have enormous impact on patient's life and which is very difficult to treat. Accumulating data indicate that chronic tinnitus is related to dysfunctional neuronal activity in the central nervous system. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method which allows to focally modulate neuronal activity. An increasing amount of studies demonstrate reduction of tinnitus after repeated sessions of low-frequency rTMS and indicate that rTMS might represent a new promising approach for the treatment of tinnitus. However available studies have been mono-centric and are characterized by small sample sizes. Therefore, this multi-center trial will test the efficacy of rTMS treatment in a large sample of chronic tinnitus patients.
METHODS/DESIGN: This is a randomized, placebo-controlled, double-blind multi-center trial of two weeks 1 Hz rTMS-treatment in chronic tinnitus patients. Eligible patients will be randomized to either 2 weeks real or sham rTMS treatment. Main eligibility criteria: male or female individuals aged 18-70 years with chronic tinnitus (duration > 6 months), tinnitus-handicap-inventory-score > or = 38, age-adjusted normal sensorineural hearing (i.e. not more than 5 dB below the 10% percentile of the appropriate age and gender group (DIN EN ISO 7029), conductive hearing loss < or = 15dB. The primary endpoint is a change of tinnitus severity according to the tinnitus questionnaire of Goebel and Hiller (baseline vs. end of treatment period). A total of 138 patients are needed to detect a clinical relevant change of tinnitus severity (i.e. 5 points on the questionnaire of Goebel and Hiller; alpha = 0.05; 1-beta = 0.80). Assuming a drop-out rate of less than 5% until the primary endpoint, 150 patients have to be randomized to guarantee the target number of 138 evaluable patients. The study will be conducted by otorhinolaryngologists and psychiatrists of 7 university hospitals and 1 municipal hospital in Germany.
This study will provide important information about the efficacy of rTMS in the treatment of chronic tinnitus.
Current Controlled Trials ISRCTN89848288.
慢性耳鸣是一种常见病症，会对患者生活产生巨大影响且极难治疗。越来越多的数据表明，慢性耳鸣与中枢神经系统中功能失调的神经元活动有关。重复经颅磁刺激（rTMS）是一种非侵入性方法，可局部调节神经元活动。越来越多的研究表明，低频rTMS多次治疗后耳鸣减轻，这表明rTMS可能是一种治疗耳鸣的新的有前景的方法。然而，现有研究多为单中心研究，且样本量较小。因此，这项多中心试验将在大量慢性耳鸣患者样本中测试rTMS治疗的疗效。
方法/设计：这是一项针对慢性耳鸣患者进行的为期两周的1Hz rTMS治疗的随机、安慰剂对照、双盲多中心试验。符合条件的患者将被随机分为接受2周真实rTMS治疗或假rTMS治疗。主要入选标准：年龄在18 - 70岁之间的男性或女性慢性耳鸣患者（病程>6个月），耳鸣 handicap 量表评分≥38，年龄校正后的正常感音神经性听力（即不超过相应年龄和性别组第10百分位数以下5dB（DIN EN ISO 7029）），传导性听力损失≤15dB。主要终点是根据Goebel和Hiller耳鸣问卷评估的耳鸣严重程度变化（基线与治疗期末）。需要总共138名患者来检测耳鸣严重程度的临床相关变化（即Goebel和Hiller问卷上5分的变化；α = 0.05；1-β = 0.80）。假设在主要终点前脱落率低于5%，则必须随机分配150名患者以确保有138名可评估患者的目标数量。该研究将由德国7所大学医院和1所市立医院的耳鼻喉科医生和精神科医生进行。
本研究将提供有关rTMS治疗慢性耳鸣疗效的重要信息。
当前受控试验ISRCTN89848288。
