Chronic tinnitus Nervous System Diseases Tinnitus
Conditions
Interventions
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 sk
Sponsors
University of Regensburg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tinnitus severity, measured using the tinnitus questionnaire of Goebel and Hiller at baseline and day 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed