Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Goeran Hajak


Contact details

Universitaetsstr. 84
+49 (0)941 941 2011

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Repetitive transcranial magnetic stimulation (rTMS) for the treatment of chronic tinnitus


Study hypothesis

Chronic tinnitus is a severe and disabling disease with so far no efficient treatment. Accumulating data point to the involvement of dysfunctional neuronal activity in the central nervous system as one possible underlying cause of chronic tinnitus. rTMS has been shown to be able to non-invasively modulate cortical activity and holds therapeutic potential in other treatment-resistant diseases such as major depression. Pilot studies revealed promising therapeutic potential of rTMS in the treatment of chronic tinnitus.

The primary objective of this trial is to evaluate the efficacy of real rTMS versus sham rTMS in the treatment of chronic tinnitus by means of change of tinnitus severity according to the tinnitus questionnaire of Goebel and Hiller (baseline versus day 12).

Ethics approval

Ethics committee of the University of Regensburg, 24/10/2006

Study design

Randomized double-blind placebo-controlled multi-center trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Chronic tinnitus


rTMS will be administered according to current safety guidelines. Figure-of-eight-coils will be used for real stimulation. Sham stimulation will be carried out by tilting the coil 45° away from the skull with one wing touching the skull. The stimulation parameters have been chosen according to successful pilot studies. Patients will be randomized to 2 parallel treatment groups:

Group A will receive real stimulation: 2 x 5 sessions, 1 Hz rTMS, stimulation intensity 110% related to the individual motor threshold, 2000 stimuli per session, coil position 10-20 guided over left primary auditory cortex.

Group B will receive sham stimulation by angulation of the magnetic coil 45° away from the skull with one wing touching the skull. Coil positioning and stimulation parameters as for group A.

Treatment will be conducted over a period of 2 weeks, at a frequency of 5 sessions/week.

Intervention type



Drug names

Primary outcome measure

Tinnitus severity, measured using the tinnitus questionnaire of Goebel and Hiller at baseline and day 12

Secondary outcome measures

Tinnitus severity, measured using the tinnitus questionnaire of Goebel and Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity scale and Cinical Global Impression Scale during the follow-up period (screening, baseline, days 5, 67 and 181)

Further outcome measures:
1. Quality of life, measured by the 12-item Short Form health survey (SF-12) at baseline, days 5, 12, 18, 67 and 181
2. Depressive symptoms, measured by the Beck Depression Inventory (BDI) at baseline, days 5, 12, 18, 67 and 181
3. Psychometric parameters of tinnitus, assessed by audiological evaluation at screening and day 18
4. Structural neuroplastic adaptation processes, detected by voxel-based morphometry at baseline and day 12
5. Cortical excitability, assessed by paired-pulse TMS at baseline and day 12

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Male or female in- and out-patients, age 18-70
2. Diagnosis of chronic tinnitus
3. Patient has a score of greater than or equal to 38 on the Tinnitus Handicap Inventory
4. Tinnitus duration of more than 6 months
5. Age-adjusted normal sensorineuronal hearing determined by an audiogram within the last 4 weeks, i.e. no more than 5 dB below the 10% percentile (DIN EN ISO 7029) of the appropriate age and gender group in all measured standard frequencies. Furthermore, no conductive hearing loss of more than 15 dB in neither of the measured standard frequencies
6. Patient naïve to rTMS-treatment

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Objective tinnitus
2. Other forms of tinnitus treatment at the same time
3. Clinically relevant psychiatric comorbidity as judged by an experienced psychiatrist
4. Concomitant treatment with psychotropic drugs
5. History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery
6. Severe unstable somatic comorbidity
7. Cardiac pace makers, other electronic implants, intracranial metallic particles
8. History of seizures or epileptiform activity
9. Pregnancy and lactation
10. Women in child bearing age without contraception
11. Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the trial
12. Patient unwilling or unable to give written informed consent
13. Participation in a clinical trial within the last 30 days before start of this clinical trial or similar participation in another clinical trial

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University of Regensburg

Sponsor information


University of Regensburg (Germany)

Sponsor details

Universitaetstr. 84

Sponsor type




Funder type


Funder name

Deutsche Forschungsgemeinschaft within a clinical studies programme (ref: HA 3547/4-1)

Alternative name(s)

German Research Foundation, DFG

Funding Body Type

private sector organisation

Funding Body Subtype




Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2008 protocol in:
2017 results in:

Publication citations

  1. Protocol

    Landgrebe M, Binder H, Koller M, Eberl Y, Kleinjung T, Eichhammer P, Graf E, Hajak G, Langguth B, Design of a placebo-controlled, randomized study of the efficacy of repetitive transcranial magnetic stimulation for the treatment of chronic tinnitus., BMC Psychiatry, 2008, 8, 23, doi: 10.1186/1471-244X-8-23.

Additional files

Editorial Notes

17/08/2017: Publication reference added.