Condition category
Nervous System Diseases
Date applied
12/09/2007
Date assigned
18/01/2008
Last edited
23/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Goeran Hajak

ORCID ID

Contact details

Universitaetsstr. 84
Regensburg
93053
Germany
+49 941 941 2011
goeran.hajak@medbo.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05/06_1

Study information

Scientific title

Acronym

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

The study has been approved by the ethics committee of the University of Regensburg on October 24th 2006.

Study design

Randomized, double-blind, placebo-controlled, multi-center trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Chronic tinnitus

Intervention

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

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change of tinnitus severity according to the tinnitus questionnaire of Goebel and Hiller (baseline versus day 12).

Secondary outcome measures

The secondary outcome parameter is a change of tinnitus severity according to 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 versus baseline versus days 5, 67 and 181).

Further outcome measures:
1. Changes in quality of life of patients as measured by the 12-item Short Form health survey (SF-12) (baseline versus days 5, 12, 18, 67 and 181)
2. Changes in depressive symptoms, measured by the Beck Depression Inventory (BDI) (baseline versus days 5, 12, 18, 67 and 181).
3. Changes of psychometric parameters of tinnitus, assessed by audiological evaluation (screening versus day 18)
4. Changes in structural neuroplastic adaptation processes, detected by voxel-based morphometry (baseline versus day 12)
5. Changes in cortical excitability, assessed by paired-pulse TMS (baseline versus day 12)

Overall trial start date

01/11/2007

Overall trial end date

01/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female in- and outpatients, age 18-70 years.
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

Patient

Age group

Adult

Gender

Both

Target number of participants

138

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

01/11/2007

Recruitment end date

01/11/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Universitaetsstr. 84
Regensburg
93053
Germany

Sponsor information

Organisation

University of Regensburg (Germany)

Sponsor details

Universitaetstr. 84
Regensburg
D-93042
Germany

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

This study is funded by the German Research Foundation (Deutsche Forschungsgemeinschaft; DFG) within a clinical studies programme (ref: HA 3547/4-1)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18412944

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