Dataset Information

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

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.

SUBMITTER: Yadollahpour A

PROVIDER: S-EPMC6178906 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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

Yadollahpour Ali A Mayo Miguel M Saki Nader N Rashidi Samaneh S Bayat Arash A

F1000Research 20180612

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 clin ...[more]

PMID: 30356442

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Project description:Background: Transcranial Direct Current Stimulation (tDCS) is reportedly a potential treatment option for chronic tinnitus. The main drawbacks of previous studies are short term follow up and focusing on the efficacy of single session tDCS. This study aims to investigate the therapeutic efficacy, adverse effects (AEs) and tolerability of repeated sessions of bilateral tDCS over auditory cortex (AC) on tinnitus symptoms Methods: This will be a double-blinded randomized placebo controlled parallel trial on patients (n=90) with intractable chronic tinnitus (> 2 years) randomly divided into three groups of anodal, cathodal, and sham tDCS. In the sham treatment, after 30 sec the device will be turned OFF without informing the patients. The tDCS protocol consists of 10 sessions (daily 20 min session; 2 mA current for 5 consecutive days per week and 2 consecutive weeks) applied through 35 cm 2 electrodes. The primary outcome is tinnitus handicap inventory (THI) which will be assessed pre- and post-intervention and at one month follow-up. The secondary outcomes are tinnitus loudness and distress to be assessed using a visual analogue scale (VAS) pre-intervention, and immediately, one hour, one week, and one month after last stimulation. The AEs and tolerability of patients will be evaluated after each session using a customized questionnaire. Possible interactions between the disease features and treatment response will be evaluated. Discussion: To our knowledge this is the first study to investigate the effects of repeated sessions of tDCS on chronic tinnitus symptoms with one month follow-up. In addition, the AEs, and tolerability of patients will be studied. In addition, the possible interactions between the disease specific features including the hearing loss, laterality, type of tinnitus, and treatment response will be evaluated. Trial registration: The study has been registered as a clinical trial in Iranian Registry of Clinical Trial ( IRCT2016110124635N6) on the 01/06/2017.

Dataset Information

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

Publications

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

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