Repetitive transcranial magnetic stimulation (rTMS) for the treatment of chronic tinnitus
| ISRCTN | ISRCTN89848288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89848288 |
| Secondary identifying numbers | 05/06_1 |
- Submission date
- 12/09/2007
- Registration date
- 18/01/2008
- Last edited
- 17/08/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Goeran Hajak
Scientific
Scientific
Universitaetsstr. 84
Regensburg
93053
Germany
| Phone | +49 (0)941 941 2011 |
|---|---|
| goeran.hajak@medbo.de |
Study information
| Study design | Randomized double-blind placebo-controlled multi-center trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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(s) | Ethics committee of the University of Regensburg, 24/10/2006 |
| 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 | Procedure/Surgery |
| 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 study start date | 01/11/2007 |
| Overall study end date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 138 |
| 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 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
Study participating centre
University of Regensburg
Regensburg
93053
Germany
93053
Germany
Sponsor information
University of Regensburg (Germany)
University/education
University/education
Universitaetstr. 84
Regensburg
D-93042
Germany
"ROR" |
https://ror.org/01eezs655 |
|---|
Funders
Funder type
Government
Deutsche Forschungsgemeinschaft within a clinical studies programme (ref: HA 3547/4-1)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/04/2008 | Yes | No | |
| Results article | results | 01/11/2017 | Yes | No |
Editorial Notes
17/08/2017: Publication reference added.
