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Brain Stimul. 2017 Nov - Dec;10(6):1112-1120. doi: 10.1016/j.brs.2017.08.001. Epub 2017 Aug 5.

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

Author information

1
Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany. Electronic address: michael.landgrebe@kbo.de.
2
Department of Psychiatry, Psychosomatics and Psychotherapy, Sozialstiftung Bamberg, St.-Getreu-Str. 18, 96049 Bamberg, Germany. Electronic address: goeran.hajak@sozialstiftung-bamberg.de.
3
Department of Otorhinolarygology, Euromed-Hospital, Europaallee 1, 90763 Fürth, Germany. Electronic address: sw@eurohno.de.
4
Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich, Nußbaumstr. 7, 80336 Munich, Germany. Electronic address: Frank.Padberg@med.uni-muenchen.de.
5
Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich, Nußbaumstr. 7, 80336 Munich, Germany. Electronic address: philipp.klupp@vivantes.de.
6
Department of Psychiatry, Psychosomatics and Psychotherapy, University of Würzburg, Margarete-Höppel-Platz 1, 97080 Würzburg, Germany. Electronic address: Andreas.Fallgatter@med.uni-tuebingen.de.
7
Department of Psychiatry, Psychosomatics and Psychotherapy, University of Würzburg, Margarete-Höppel-Platz 1, 97080 Würzburg, Germany. Electronic address: Polak_T@ukw.de.
8
Department of Psychiatry and Psychotherapy, Rostock University Medical Center, Gehlsheimer Str. 20, 18147 Rostock, Germany. Electronic address: jacqueline.hoeppner@helios-kliniken.de.
9
Department of Internal Medicine, Rostock University Medical Center, Ernst-Heydemann-Str. 6, 18057, Rostock, Germany. Electronic address: rene.haker@uni-rostock.de.
10
Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine University, Bergische Landstr. 2, 40629 Düsseldorf, Germany. Electronic address: joachim.cordes@lvr.de.
11
Department of Head and Neck Surgery, University Hospital Düsseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany. Electronic address: Thomas.Klenzner@med.uni-duesseldorf.de.
12
Department of Psychiatry, Psychosomatics and Psychotherapy III, University of Ulm, Leimgrubenweg 12 -14, 89075 Ulm, Germany. Electronic address: carlos.schoenfeldt@uni-ulm.de.
13
Department of Psychiatry, Psychosomatics and Psychotherapy III, University of Ulm, Leimgrubenweg 12 -14, 89075 Ulm, Germany. Electronic address: thomas.kammer@uni-ulm.de.
14
Institute for Medical Biometry and Statistics, Faculty of Medicine and Medical Center - University of Freiburg, Elsässer Str. 2, Freiburg, Germany. Electronic address: erika.graf@uniklinik-freiburg.de.
15
Center for Clinical Trials, University of Regensburg, Franz-Josef-Strauß-Allee 11, 93053 Regensburg, Germany. Electronic address: michael.koller@klinik.uni-regensburg.de.
16
Department of Otorhinolaryngology, University of Regensburg, Franz-Josef-Strauß-Allee 11, 93053 Regensburg, Germany. Electronic address: Tobias.kleinjung@usz.ch.
17
Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany. Electronic address: astrid.lehner@medbo.de.
18
Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany. Electronic address: martin.schecklmann@medbo.de.
19
Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany. Electronic address: timm.poeppl@medbo.de.
20
Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany. Electronic address: peter.kreuzer@medbo.de.
21
Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany. Electronic address: elmar.frank@medbo.de.
22
Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany. Electronic address: berthold.langguth@medbo.de.

Abstract

BACKGROUND:

Chronic tinnitus is a frequent, difficult to treat disease with high morbidity.

OBJECTIVE:

This 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.

METHODS:

Tinnitus 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.

RESULTS:

A 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.

CONCLUSION:

Real 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 REGISTRATION:

Controlled Trials: http://www.isrctn.com/ISRCTN89848288.

KEYWORDS:

Auditory phantom perception; Evidence-based psychiatry; Neurostimulation; RCT; Repetitive transcranial magnetic stimulation; Tinnitus

PMID:
28807845
DOI:
10.1016/j.brs.2017.08.001
[Indexed for MEDLINE]

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