A chronic protocol of bilateral transcranial direct current stimulation over auditory cortex for tinnitus treatment: Dataset from a double-blinded randomized controlled trial.

Miguel Mayo,Nader Saki,Arash Bayat,Samaneh Rashidi,Ali Yadollahpour

doi:10.12688/f1000research.14971.1

Abstract

Preliminary studies have demonstrated the therapeutic potential of transcranial direct current stimulation (tDCS) for chronic tinnitus. However, the findings are controversial and most of the studies investigated effects of a single session of tDCS and short after-effects, ranging from hours to days. To our knowledge, there is no published study investigating the effects of a chronic protocol of bilateral tDCS over auditory cortex (AC) with one month follow-up in a double blinded randomized clinical trial. This dataset presents the results of a double-blinded placebo controlled trial investigating the effects of chronic protocol (10 sessions) of tDCS over AC with 1 month follow-up. The data of the two groups, real tDCS (n=25) and sham tDCS (n=15), are reported. The dataset includes three main data groups: patient- and tinnitus-specific data, data of the primary and secondary outcomes, and data on the adverse effects of and tolerability to tDCS. The first group includes demographic information, audiometric assessments, and tinnitus-specific characteristics. The second group includes tinnitus handicap inventory (THI) scores, tinnitus loudness, and tinnitus related distress based on 0-10 numerical visual analogue scale (VAS) scores. The values of the primary and secondary outcomes for pre-intervention and at different time points following interventions are presented. THI scores pre-intervention and immediately post-intervention and at 1 month follow-up; the scores of tinnitus loudness and distress scores for pre-intervention, and immediately, 1 hour, 1 week, and at 1 month after the last stimulation session are presented. Moreover, the adverse effects of and tolerability to the tDCS were assessed using a customized questionnaire after the last tDCS session. This dataset can be used alone or in combination with other datasets using advanced statistical analyses and modeling to investigate the treatment efficacy of tDCS in chronic intractable tinnitus.

Highlights

Tinnitus is a phantom auditory perception in the absence of external sound that affects 10–15% of the world adult population, present in different forms, including buzzing, hissing, pulsatile, ringing and pulsatile tone1,2
This dataset presents the results of a double blinded randomized placebo controlled clinical trial investigated the effects of chronic protocol of bilateral Transcranial direct current stimulation (tDCS) over auditory cortex (AC) in intractable chronic tinnitus (n=40)18
A 1-month follow-up is relatively long compared to the similar studies14–16 conducted so far; ; it is necessary to increase the follow-up assessments further to several months. Such datasets can be used alone or in combination with other datasets, using advanced statistical analyses and modeling to identify the influencing parameters of tDCS as well as patient-specific features correlating with the therapeutic outcomes of the tDCS. This dataset presents the effects of tDCS in tinnitus symptoms in a double-blinded randomized placebo-controlled trial with a

Summary

Introduction

Tinnitus is a phantom auditory perception in the absence of external sound that affects 10–15% of the world adult population, present in different forms, including buzzing, hissing, pulsatile, ringing and pulsatile tone. Despite the development of different non-pharmaceutical techniques including cognitive behavioral therapies, noisemasking modalities, and neurofeedback, the efficacies of these treatments for tinnitus are limited. To achieve an effective tDCS protocol, different clinical studies with large sample sizes and robust designs should be conducted to identify the effective electrode montage and stimulation parameters. For long-term tDCS protocols, assessing the possible adverse effects is necessary In this regard, we have designed a comprehensive project to assess the efficacy of different protocols of tDCS with different electrode montages over different sites of the brain for intractable tinnitus. To the best of our knowledge, this is the first randomized clinical trial to investigate the effects of repeated sessions of tDCS on intractable chronic tinnitus symptoms and comorbid depression and anxiety with a 1-month follow-up. The main feature of these data is that the patients, the researcher who evaluated the outcomes, and the researcher who performed the statistical analyses were blinded to the study

Participants and dataset schema

Study design

Utility and discussion

Conclusion