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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

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          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 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 registration

          Swiss Ethics Committee (BASEC-Nr. 2020-02027); Swiss Federal Complementary Database (kofam.ch: SNCTP000004051); and ClinicalTrials.gov (clinicaltrials.gov: NCT04551404).

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          Most cited references73

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          FieldTrip: Open Source Software for Advanced Analysis of MEG, EEG, and Invasive Electrophysiological Data

          This paper describes FieldTrip, an open source software package that we developed for the analysis of MEG, EEG, and other electrophysiological data. The software is implemented as a MATLAB toolbox and includes a complete set of consistent and user-friendly high-level functions that allow experimental neuroscientists to analyze experimental data. It includes algorithms for simple and advanced analysis, such as time-frequency analysis using multitapers, source reconstruction using dipoles, distributed sources and beamformers, connectivity analysis, and nonparametric statistical permutation tests at the channel and source level. The implementation as toolbox allows the user to perform elaborate and structured analyses of large data sets using the MATLAB command line and batch scripting. Furthermore, users and developers can easily extend the functionality and implement new algorithms. The modular design facilitates the reuse in other software packages.
            • Record: found
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            • Article: not found

            10/20, 10/10, and 10/5 systems revisited: their validity as relative head-surface-based positioning systems.

            With the advent of multi-channel EEG hardware systems and the concurrent development of topographic and tomographic signal source localization methods, the international 10/20 system, a standard system for electrode positioning with 21 electrodes, was extended to higher density electrode settings such as 10/10 and 10/5 systems, allowing more than 300 electrode positions. However, their effectiveness as relative head-surface-based positioning systems has not been examined. We previously developed a virtual 10/20 measurement algorithm that can analyze any structural MR head and brain image. Extending this method to the virtual 10/10 and 10/5 measurement algorithms, we analyzed the MR images of 17 healthy subjects. The acquired scalp positions of the 10/10 and 10/5 systems were normalized to the Montreal Neurological Institute (MNI) stereotactic coordinates and their spatial variability was assessed. We described and examined the effects of spatial variability due to the selection of positioning systems and landmark placement strategies. As long as a detailed rule for a particular system was provided, it yielded precise landmark positions on the scalp. Moreover, we evaluated the effective spatial resolution of 329 scalp landmark positions of the 10/5 system for multi-subject studies. As long as a detailed rule for landmark setting was provided, 241 scalp positions could be set effectively when there was no overlapping of two neighboring positions. Importantly, 10/10 positions could be well separated on a scalp without overlapping. This study presents a referential framework for establishing the effective spatial resolutions of 10/20, 10/10, and 10/5 systems as relative head-surface-based positioning systems.
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              Phantom auditory perception (tinnitus): mechanisms of generation and perception.

              Phantom auditory perception--tinnitus--is a symptom of many pathologies. Although there are a number of theories postulating certain mechanisms of its generation, none have been proven yet. This paper analyses the phenomenon of tinnitus from the point of view of general neurophysiology. Existing theories and their extrapolation are presented, together with some new potential mechanisms of tinnitus generation, encompassing the involvement of calcium and calcium channels in cochlear function, with implications for malfunction and aging of the auditory and vestibular systems. It is hypothesized that most tinnitus results from the perception of abnormal activity, defined as activity which cannot be induced by any combination of external sounds. Moreover, it is hypothesized that signal recognition and classification circuits, working on holographic or neuronal network-like representation, are involved in the perception of tinnitus and are subject to plastic modification. Furthermore, it is proposed that all levels of the nervous system, to varying degrees, are involved in tinnitus manifestation. These concepts are used to unravel the inexplicable, unique features of tinnitus and its masking. Some clinical implications of these theories are suggested.

                Author and article information

                Contributors
                tobias.kleinjung@usz.ch
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                19 May 2022
                19 May 2022
                2022
                : 23
                : 418
                Affiliations
                [1 ]GRID grid.7400.3, ISNI 0000 0004 1937 0650, Department of Otorhinolaryngology - Head and Neck Surgery, University Hospital of Zurich, , University of Zurich, ; Zurich, Switzerland
                [2 ]GRID grid.411216.1, ISNI 0000 0004 0397 5145, Graduate Program in Cognitive Neuroscience and Behavior, , Federal University of Paraiba, ; João Pessoa, Brazil
                [3 ]GRID grid.7400.3, ISNI 0000 0004 1937 0650, Division of Neuropsychology, Psychological Institute, , University of Zurich, ; Zurich, Switzerland
                [4 ]GRID grid.7400.3, ISNI 0000 0004 1937 0650, University Research Priority Program “Dynamics of Healthy Aging”, , University of Zurich, ; Zurich, Switzerland
                [5 ]GRID grid.7039.d, ISNI 0000000110156330, Centre for Cognitive Neuroscience and Department of Psychology, , University of Salzburg, ; Salzburg, Austria
                [6 ]GRID grid.7727.5, ISNI 0000 0001 2190 5763, Department of Psychiatry and Psychotherapy, , University of Regensburg, ; Regensburg, Germany
                Author information
                http://orcid.org/0000-0003-3867-234X
                Article
                6253
                10.1186/s13063-022-06253-5
                9118607
                f80a693c-ab7e-4d4f-b1f4-01963b950e3f
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 18 June 2021
                : 29 March 2022
                Funding
                Funded by: swiss government excellence scholarship
                Award ID: 2020.0148
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2022

                Medicine
                tinnitus,transcranial random noise stimulation,acoustic stimulation,hearing,auditory perception,psychoacoustics,audiology

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