ArticleTrials2022
Transcranial electric and acoustic stimulation for tinnitus: study protocol for a randomized double-blind controlled trial assessing the influence of combined transcranial random noise and acoustic stimulation on tinnitus loudness and distress.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04551404 (Transcranial Electrical and Acoustic Stimulation for Tinnitus), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Transcranial Electrical and Acoustic Stimulation for Tinnitus: A Randomized Double Blind Clinical Trial
Who cites it
1 citing paper in PubMed, 3 citations in OpenAlex.
- Effect of Simultaneous Use of Neuromodulation and Acoustic Stimulation in the Management of Tinnitus.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 4 countries.
Funding
Abstract
backgroundTinnitus 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.
methodsThe 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. DISCUSSION: 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.
trial registrationSwiss Ethics Committee (BASEC-Nr. 2020-02027); Swiss Federal Complementary Database (kofam.ch: SNCTP000004051 ); and ClinicalTrials.gov (clinicaltrials.gov: NCT04551404 ).
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