Original Article - The International Tinnitus Journal (2018) Volume 22, Issue 2
The Effects of Acute Multisession Bifrontal Transcranial Direct Current Stimulation on Intractable Tinnitus and comorbid depression and anxiety: A Study Protocol for Randomized Controlled Trial
Background and Objective: Transcranial Direct Current Stimulation (tDCS) may exert therapeutic effects on tinnitus. This Randomized Control Trial (RCT) with double blind and placebo design investigates the potential therapeutic effects of Transcranial Direct Current Stimulation on chronic and intractable tinnitus using a new protocol. Acute repeated sessions of bifrontal Transcranial Direct Current Stimulation with two months follow up will be used for treatment of tinnitus symptoms and comorbid anxiety and depression. To best of our knowledge, this is the first randomized control trial investigating the effects of acute Transcranial Direct Current Stimulation exposure in intractable tinnitus.
Methods: This randomized control trial is conducted as double blinded placebo controlled with parallel group in patients with chronic intractable tinnitus. The patients will be randomly divided into two real or intervention and sham or placebo Transcranial Direct Current Stimulation. The real Transcranial Direct Current Stimulation group will receive two sessions per day with intersession interval of 6 hours for 5 consecutive days per week for one week (total 10 sessions). The Transcranial Direct Current Stimulation parameters include bifrontal (anode/cathode over right/left dorsolateral prefrontal cortex (DLPFC) 2 mA current (current density 57.1 μA/cm2), each session 20 min through 35 cm2 electrodes. The sham group will receive the same Transcranial Direct Current Stimulation parameters and electrode montage and after 30 seconds, the device will be turned off without informing the patient. The primary outcome is the score of Tinnitus Handicap Inventory (THI) measured at baseline (pre-intervention) and post-intervention at immediately, one, and two months after last session. The secondary outcomes are tinnitus loudness, tinnitus distress, depression, and anxiety scores. The tinnitus loudness and distress are measured with a 0-10 Numerical Rating Scale (NRS) preintervention and post-intervention at immediately, one hour, one week, one, and two months after the last Transcranial Direct Current Stimulation session. Beck Depression (BDI-II) and Anxiety Inventories (BAI) is respectively used for measuring depression and anxiety score pre- and post-intervention. Finally, the adverse effects of and tolerability to Transcranial Direct Current Stimulation will be assessed in both real and sham groups using customized questionnaire.
Discussion: To the best of our knowledge this is the first RCT investigating the effects of daily two sessions of Transcranial Direct Current Stimulation in repeated regime on chronic intractable tinnitus symptoms, depression, anxiety, and adverse effects in a long term study of two months follow-up.