Evidence map›Paper›PMID 18412944›Full record

Trial reportBMC psychiatry2008

Design of a placebo-controlled, randomized study of the efficacy of repetitive transcranial magnetic stimulation for the treatment of chronic tinnitus.

Michael Landgrebe, Harald Binder, Michael Koller, Yvonne Eberl, Tobias Kleinjung, Peter Eichhammer, Erika Graf, Goeran Hajak, Berthold Langguth

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC psychiatry, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Therapeutic impact of repetitive transcranial magnetic stimulation (rTMS) on tinnitus: a systematic review and meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2016
    Pooled it
  2. Pooled it
  3. The efficacy of auditory perceptual training for tinnitus: a systematic review.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2010
    Pooled it
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  14. Predictors for rTMS response in chronic tinnitus.Frontiers in systems neuroscience · 2012
    Article
  15. Review
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Michael LandgrebeDepartment of Psychiatry, Psychosomatics, and Psychotherapy, University of Regensburg, Germany. michael.landgrebe@medbo.de
Harald Binder
Michael Koller
Yvonne Eberl
Tobias Kleinjung
Peter Eichhammer
Erika Graf
Goeran Hajak
Berthold Langguth

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic tinnitus is a frequent condition, which can have enormous impact on patient's life and which is very difficult to treat. Accumulating data indicate that chronic tinnitus is related to dysfunctional neuronal activity in the central nervous system. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method which allows to focally modulate neuronal activity. An increasing amount of studies demonstrate reduction of tinnitus after repeated sessions of low-frequency rTMS and indicate that rTMS might represent a new promising approach for the treatment of tinnitus. However available studies have been mono-centric and are characterized by small sample sizes. Therefore, this multi-center trial will test the efficacy of rTMS treatment in a large sample of chronic tinnitus patients. METHODS/

designThis is a randomized, placebo-controlled, double-blind multi-center trial of two weeks 1 Hz rTMS-treatment in chronic tinnitus patients. Eligible patients will be randomized to either 2 weeks real or sham rTMS treatment. Main eligibility criteria: male or female individuals aged 18-70 years with chronic tinnitus (duration > 6 months), tinnitus-handicap-inventory-score > or = 38, age-adjusted normal sensorineural hearing (i.e. not more than 5 dB below the 10% percentile of the appropriate age and gender group (DIN EN ISO 7029), conductive hearing loss < or = 15dB. The primary endpoint is a change of tinnitus severity according to the tinnitus questionnaire of Goebel and Hiller (baseline vs. end of treatment period). A total of 138 patients are needed to detect a clinical relevant change of tinnitus severity (i.e. 5 points on the questionnaire of Goebel and Hiller; alpha = 0.05; 1-beta = 0.80). Assuming a drop-out rate of less than 5% until the primary endpoint, 150 patients have to be randomized to guarantee the target number of 138 evaluable patients. The study will be conducted by otorhinolaryngologists and psychiatrists of 7 university hospitals and 1 municipal hospital in Germany. DISCUSSION: This study will provide important information about the efficacy of rTMS in the treatment of chronic tinnitus.

trial registrationCurrent Controlled Trials ISRCTN89848288.

Indexed as

Transcranial Magnetic StimulationAdolescentAdultAgedAuditory CortexChronic DiseaseDepressionDominance, CerebralDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedPerceptual MaskingQuality of Life

Identifiers

PMID18412944
PMCPMC2358898

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.