Comparing single-site with multisite rTMS for the treatment of chronic tinnitus - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial.

BACKGROUND

Several years ago, repetitive transcranial magnetic stimulation (rTMS) of the auditory cortex has been introduced as a treatment approach for chronic tinnitus. Even if this treatment is beneficial for a subgroup of patients, the overall effects are limited. This limitation may be due to the fact that the auditory cortex is only one of several brain areas involved in tinnitus. Whereas auditory areas are considered to code for tinnitus loudness, conscious perception of and attention allocation to tinnitus is supposed to be reflected by network activity involving frontal and parietal cortical areas. The aim of the present study is to influence this frontoparietal network more efficiently by perturbing the most important nodes with rTMS.

METHODS/DESIGN: This is a randomized, double-blind, parallel-group study. Patients receive rTMS treatment on 10 consecutive working days using either the multisite rTMS protocol (left dorsolateral prefrontal, 1,000 stimuli, 20 Hz; left temporoparietal, 1,000 stimuli, 1 Hz; right temporoparietal stimulation, 1,000 stimuli, 1 Hz) or a single-site protocol (unilateral stimulation of the temporoparietal cortex, 3,000 stimuli, 1 Hz). Individuals aged 18 to 70 years with chronic tinnitus ≥6-month duration and a Tinnitus Handicap Inventory score ≥38 are recruited for the study. A total of 50 patients are needed to detect a clinical relevant change of tinnitus severity (α = 0.05; 1 - β = 0.80). Primary outcome measures are the change in the Tinnitus Questionnaire score from baseline to the end of treatment as well as the number of treatment responders as defined by a reduction in the Tinnitus Questionnaire score of ≥5 points. Furthermore, changes in brain structure and activity are assessed using (functional) magnetic resonance imaging and electroencephalography in the resting state. Those measurements are also performed in 25 healthy control subjects.

DISCUSSION

This study is designed to reveal whether network stimulation is superior to single-site stimulation in the treatment of chronic tinnitus. Furthermore, the comparison between tinnitus patients and healthy controls and the longitudinal effects of both rTMS treatment protocols on brain structure and function allow inferences to be made about the neural correlates of tinnitus.

TRIAL REGISTRATION

Clinical Trials: NCT01663324.