1-Hz rTMS in the treatment of tinnitus: A sham-controlled, randomized multicenter trial

Publication date: Available online 5 August 2017
Source:Brain Stimulation
Author(s): Michael Landgrebe, Göran Hajak, Stefan Wolf, Frank Padberg, Philipp Klupp, Andreas J. Fallgatter, Thomas Polak, Jacqueline Höppner, Rene Haker, Joachim Cordes, Thomas Klenzner, Carlos Schönfeldt-Lecuona, Thomas Kammer, Erika Graf, Michael Koller, Tobias Kleinjung, Astrid Lehner, Martin Schecklmann, Timm B. Pöppl, Peter Kreuzer, Elmar Frank, Berthold Langguth
BackgroundChronic tinnitus is a frequent, difficult to treat disease with high morbidity.ObjectiveThis multicenter randomized, sham-controlled trial investigated the efficacy and safety of 1-Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left temporal cortex in patients with chronic tinnitus.MethodsTinnitus patients were randomized to receive 10 sessions of either real or sham 1-Hz-rTMS (2000 stimuli, 110% motor threshold) to the left temporal cortex. The primary outcome was the change in the sum score of the tinnitus questionnaire (TQ) of Goebel and Hiller from baseline to end of treatment.ResultsA total of 163 patients were enrolled in the study (real rTMS: 75; sham rTMS: 78). At day 12, the baseline mean of 43.1 TQ points in 71 patients assigned to real rTMS changed by −0.5 points; it changed by 0.5 points from a baseline of 42.1 in 75 patients randomized to sham rTMS (adjusted mean difference between groups: −1.0; 95.19% confidence interval: −3.2 to 1.2; p = 0.36). All secondary outcome measures including measures of depression and quality of life showed no significant differences either (p > 0.11). The number of participants with side-effects or adverse events did not differ between groups.ConclusionReal 1-Hz-rTMS over the left temporal cortex was well tolerated but not superior compared with sham rTMS in improving tinnitus severity. These findings are in contrast to results from studies with smaller sample sizes and put the efficacy of this rTMS protocol for treatment of chronic tinnitus into question.Trial RegistrationControlled Trials: http://ift.tt/2vzTtn0.



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