Abstract
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.
Highlights
Transcranial Direct Current Stimulation is reportedly a potential treatment option for chronic tinnitus
This study aims to investigate the effects of repeated sessions of Transcranial Direct Current Stimulation (tDCS) on tinnitus symptoms with one month follow-up
In this double blinded placebo controlled randomized trial will be conducted on intractable tinnitus patients (n=90) who will be randomly divided into three groups of anodal, cathodal
Summary
Transcranial Direct Current Stimulation (tDCS) is reportedly a potential treatment option for chronic tinnitus. Tinnitus is a subjective auditory phantom perception without an external physical sound source, which exists in different forms including pulsatile or continuous, buzzing, ringing, hissing, tone, or a combination of them. Tinnitus is a subjective auditory phantom perception without an external physical sound source, which exists in different forms including pulsatile or continuous, buzzing, ringing, hissing, tone, or a combination of them2 It is a relatively common disorder with 10–15% prevalence among adults worldwide. Different non-pharmacological techniques have been developed for treatment of chronic tinnitus including cognitive behavioral therapies, hearing aids, neurofeedback, and noisemasking techniques. Different non-pharmacological techniques have been developed for treatment of chronic tinnitus including cognitive behavioral therapies, hearing aids, neurofeedback, and noisemasking techniques4–6 Some of these techniques have shown therapeutic outcomes, the therapeutic efficacies of these techniques are limited and studies to develop more efficient techniques are ongoing
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