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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

Martins, Mariana Lopes; Kleinjung, Tobias; Meyer, Martin; Raveenthiran, Vitushika; Wellauer, Zino; Peter, Nicole; Neff, Patrick (2021). 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. Research Square 637175/v1, University of Zurich.

Abstract

Background: 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.

Methods: The intervention consists of bilateral HD-tRNS over the auditory cortex combined with the application of AS which is studied in a cross-over 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 analogue 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 cross-over 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.

Additional indexing

Item Type:Working Paper
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Otorhinolaryngology
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:13 August 2021
Deposited On:07 Jan 2022 09:31
Last Modified:29 May 2024 12:12
Series Name:Research Square
ISSN:2693-5015
OA Status:Green
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.21203/rs.3.rs-637175/v1
Official URL:https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-022-06253-5.pdf
Related URLs:https://www.zora.uzh.ch/id/eprint/218727/
https://pubmed.ncbi.nlm.nih.gov/35590399/
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06253-5
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  • Licence: Creative Commons: Attribution 4.0 International (CC BY 4.0)

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