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

Michael Landgrebe¹ , Harald Binder⁴ , Michael Koller² , Yvonne Eberl² , Tobias Kleinjung³ , Peter Eichhammer¹ , Erika Graf⁴ , Goeran Hajak¹ and Berthold Langguth¹

¹Department of Psychiatry, Psychosomatics, and Psychotherapy, University of Regensburg, Germany

²Center for Clinical Studies, University Hospital of Regensburg, Germany

³Department of Otorhinolarnygology, University Hospital of Regensburg, Germany

⁴Institute of Medical Biometry and Medical Informatics, University Medical Center Freiburg, Germany

author email corresponding author email

BMC Psychiatry 2008, 8:23doi:10.1186/1471-244X-8-23


Published:	15 April 2008

Abstract

Background

Chronic 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/Design

This 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 ≥ 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 ≤ 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 registration

Current Controlled Trials ISRCTN89848288