慢性主观性耳鸣的序贯双部位高清经颅直流电刺激（HD-tDCS）治疗：一项双盲、随机、安慰剂对照试验的研究方案
Sequential dual-site High-Definition transcranial Direct Current Stimulation (HD-tDCS) treatment in chronic subjective tinnitus: study protocol of a double-blind, randomized, placebo-controlled trial.
作者信息
Cardon E, Van Rompaey V, Jacquemin L, Mertens G, Vermeersch H, Joossen I, Beyers J, Vanderveken O M, Van de Heyning P, Topsakal V, Gilles A
机构信息
Department of Translational Neurosciences, Faculty of Medicine and Health Sciences, Campus Drie Eiken, Antwerp University, Antwerp, Belgium.
Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Wilrijkstraat 10, 2650, Edegem, Belgium.
出版信息
Trials. 2019 Aug 1;20(1):471. doi: 10.1186/s13063-019-3594-y.
BACKGROUND
Chronic tinnitus is a highly prevalent symptom, with many patients reporting considerable effects of tinnitus on quality of life. No clear evidence-based treatment options are currently available. While counseling-based methods are valuable in some cases, they are not sufficiently effective for all tinnitus patients. Neuromodulation techniques such as high-definition transcranial direct current stimulation (HD-tDCS) are proposed to have positive effects on tinnitus severity but, to date, these effects have not been proven conclusively. The proposed trial will investigate the hypothesis that chronic tinnitus patients receiving HD-tDCS will report a positive effect on the impact of tinnitus on daily life, as compared to patients receiving sham stimulation.
METHODS
This study proposes a randomized, double-blind, placebo-controlled trial with parallel group design. A total of 100 chronic tinnitus patients will be randomly allocated to an experimental group or a sham group, with allocation stratified according to gender and tinnitus severity. Patient and researcher will be blinded to the patient's allocation. Patients will undergo six sessions of sequential dual-site HD-tDCS of the left temporal area and the right dorsolateral prefrontal cortex. Evaluations will take place at baseline, immediately following treatment, and at three and six months after the start of the therapy. The primary outcome measure is the change in Tinnitus Functional Index (TFI) score. Secondary outcome measures include audiological measurements, cortical auditory evoked potentials, the Repeatable Battery for the Assessment of Neuropsychological Status adjusted for hearing-impaired individuals (RBANS-H), and supplementary questionnaires probing tinnitus severity and additional symptoms. By use of a linear regression model, the effects of HD-tDCS compared to sham stimulation will be assessed.
DISCUSSION
The objective of this study is to evaluate whether HD-tDCS can reduce the impact of tinnitus on daily life in chronic tinnitus patients. To date, published trials on the effects of HD-tDCS on tinnitus suffer from a lack of standardization and few randomized controlled trials exist. The proposed study will be the first adequately powered trial to investigate the effects of sequential dual-site HD-tDCS on tinnitus severity.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03754127 . Registered on 22 November 2018.
背景
慢性耳鸣是一种非常普遍的症状，许多患者报告耳鸣对生活质量有相当大的影响。目前尚无明确的循证治疗方案。虽然基于咨询的方法在某些情况下有价值，但对所有耳鸣患者来说并不足够有效。诸如高清晰度经颅直流电刺激（HD-tDCS）等神经调节技术被认为对耳鸣严重程度有积极影响，但迄今为止，这些影响尚未得到确凿证实。拟进行的试验将研究这样一个假设：与接受假刺激的患者相比，接受HD-tDCS的慢性耳鸣患者在耳鸣对日常生活的影响方面将报告有积极效果。
方法
本研究提出一项采用平行组设计的随机、双盲、安慰剂对照试验。总共100名慢性耳鸣患者将被随机分配到实验组或假刺激组，分配将根据性别和耳鸣严重程度进行分层。患者和研究人员将对患者的分配情况不知情。患者将接受六次对左侧颞区和右侧背外侧前额叶皮质的序贯双部位HD-tDCS治疗。评估将在基线、治疗结束后立即以及治疗开始后三个月和六个月进行。主要结局指标是耳鸣功能指数（TFI）评分的变化。次要结局指标包括听力学测量、皮质听觉诱发电位、针对听力受损个体调整后的可重复神经心理状态评估量表（RBANS-H）以及探究耳鸣严重程度和其他症状的补充问卷。通过使用线性回归模型，将评估HD-tDCS与假刺激相比的效果。
讨论
本研究的目的是评估HD-tDCS是否能减轻慢性耳鸣患者耳鸣对日常生活的影响。迄今为止，已发表的关于HD-tDCS对耳鸣影响的试验缺乏标准化，且几乎没有随机对照试验。拟进行的研究将是首个有足够效力来研究序贯双部位HD-tDCS对耳鸣严重程度影响的试验。
试验注册
ClinicalTrials.gov，NCT03754127。于2018年11月22日注册。
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