Department of Otorhinolaryngology - Head and Neck Surgery, University Hospital of Zurich, University of Zurich, Zurich, Switzerland.
Graduate Program in Cognitive Neuroscience and Behavior, Federal University of Paraiba, João Pessoa, Brazil.
Trials. 2022 May 19;23(1):418. doi: 10.1186/s13063-022-06253-5.
Tinnitus is the result of aberrant neuronal activity. As a novel treatment form, neuromodulation is used to modify neuronal activity of brain areas involved in tinnitus generation. Among the different forms of electric stimulation, transcranial random noise stimulation (tRNS) has been shown to be a promising treatment option for tinnitus. In addition, recent studies indicate that the reduction in tinnitus can be more pronounced when different modalities of stimulation techniques are combined ("bimodal stimulation"). TRNS can be used in combination with acoustic stimulation (AS), a further treatment option recognized in the literature. The aim of the proposed study is to investigate whether simultaneous tRNS and AS improve levels of tinnitus loudness and distress.
The intervention consists of bilateral high-definition tRNS (HD-tRNS) over the auditory cortex combined with the application of AS which is studied in a crossover design. The visits will be performed in 26 sessions. There will be 20 treatment sessions, divided into two blocks: active and sham HD-tRNS. Within the blocks, the interventions are divided into group A: HD-tRNS and AS, and group B: HD-tRNS alone. Furthermore, in addition to the assessments directly following the intervention sessions, there will be six extra sessions performed subsequently at the end of each block, after a period of some days (follow-ups 1 and 2) and a month after the last intervention (C). Primary outcome measures are analog scales for evaluation of subjective tinnitus loudness and distress, and the audiological measurement of minimum masking level (MML). Secondary outcome measures are brain activity as measured by electroencephalography and standardized questionnaires for evaluating tinnitus distress and severity.
To the best of our knowledge, this is the first study which uses HD-tRNS combined with AS for tinnitus treatment. The crossover design permits the comparison between HD-tRNS active vs. sham and with vs. without AS. Thus, it will be possible to evaluate the efficacy of the combined approach to HD-tRNS alone. In addition, the use of different objective and subjective evaluations for tinnitus enable more reliable and valid results.
Swiss Ethics Committee (BASEC-Nr. 2020-02027); Swiss Federal Complementary Database (kofam.ch: SNCTP000004051 ); and ClinicalTrials.gov (clinicaltrials.gov: NCT04551404 ).
耳鸣是异常神经元活动的结果。作为一种新的治疗形式，神经调节用于改变与耳鸣产生相关的脑区的神经元活动。在不同形式的电刺激中，经颅随机噪声刺激（tRNS）已被证明是一种有前途的耳鸣治疗选择。此外，最近的研究表明，当刺激技术的不同模式结合使用时（“双模态刺激”），耳鸣的减轻程度可以更加明显。tRNS 可与声学刺激（AS）联合使用，AS 是文献中认可的另一种治疗选择。本研究旨在探讨同时使用 tRNS 和 AS 是否能改善耳鸣响度和困扰程度。
干预措施包括双侧高清晰度 tRNS（HD-tRNS）在听觉皮层上的应用，与 AS 的应用相结合，采用交叉设计进行研究。就诊将在 26 次就诊中进行。将进行 20 次治疗就诊，分为两个块：主动和假 HD-tRNS。在块内，干预措施分为两组：A 组：HD-tRNS 和 AS，B 组：HD-tRNS 单独。此外，除了直接在干预就诊后进行评估外，还将在每个块结束后的几天内（随访 1 和 2）和最后一次干预后一个月（C）进行六次额外就诊。主要的测量指标是评估主观耳鸣响度和困扰的模拟量表，以及最小掩蔽级（MML）的听觉测量。次要测量指标是脑电活动，以及评估耳鸣困扰和严重程度的标准化问卷。
据我们所知，这是首次使用 HD-tRNS 结合 AS 治疗耳鸣的研究。交叉设计允许比较 HD-tRNS 主动与假、与 AS 与无 AS。因此，可以评估 HD-tRNS 单独联合方法的疗效。此外，使用不同的客观和主观耳鸣评估方法可以获得更可靠和有效的结果。
瑞士伦理委员会（BASEC-Nr. 2020-02027）；瑞士联邦补充数据库（kofam.ch：SNCTP000004051）；和 ClinicalTrials.gov（clinicaltrials.gov：NCT04551404）。
