Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation

Study Overview
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Brief Summary
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In the first visit a magnetic resonance imaging measurement will be done for the use of a neuronavigation System with the aim to control for stable coil position over the course of the trial. EEG positions CP5/CP6 will be used for positioning the coil. Two test sessions will examine the temporary reductions in tinnitus loudness after 1Hz, 10Hz, 20Hz and 0.1Hz rTMS as control condition over left and right temporo-parietal junction accompanied by electroencephalography. For the two-week treatment three arms will be evaluated: standard treatment (1Hz left-sided) in the groups with and without temporary reductions in test sessions and the best protocol as elicited in test sessions.

Detailed Description
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Efficacy of repetitive transcranial magnetic stimulation (rTMS) in chronic tinnitus is moderate. So far single sessions and daily treatment of rTMS were rarely combined. Thus it is not clear if temporary reductions in tinnitus loudness as elicited by short single rTMS sessions can be transferred to daily rTMS treatment. Thus, the aim of the study is to investigate the efficacy and reliability of single sessions of rTMS in chronic tinnitus with respect to temporary reductions in tinnitus loudness accompanied with resting state electroencephalography measurements to investigate the neurophysiological correlates of tinnitus reductions. Two test sessions within one week will be done on the left and right temporoparietal junction using 1Hz, 10Hz, 20Hz and 0.1Hz as active control condition. In the next step patients are divided into three arms with the aim to investigate the efficacy of individualized rTMS. The three arms are 1) patients with temporary tinnitus reductions in test sessions: treatment with the best, most reliable, controlled and most tolerable protocol, 2) patients with temporary tinnitus reductions in test sessions: treatment with 1Hz left-sided rTMS, 3) patients with no temporary tinnitus reductions in test sessions: treatment with 1Hz left-sided rTMS. Treatment will be done for 10 days (Monday - Friday) using 2000 pulses with 110% resting motor threshold. Coil position will be tracked with neuronavigation to ensure stable coil Position over the course of the trial.

Official Title
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Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation

Conditions
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Tinnitus

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: chronic tinnitus (> 6 months) at least moderate tinnitus distress no or consistent medication no or consistent Treatments residence in Germany and German speaking Exclusion Criteria: objective tinnitus serious and not stable illness (e.g. acute psychosis, severe depression or substance dependence, epilepsy, brain tumor) meeting the contraindications for transcranial magnetic stimulation or magnetic resonance imaging (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump) neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma) addictive disorder with consumption in the last two years regular intake of benzodiazepines participation in another study parallel to the trial pregnancy or breastfeeding period psychiatric confinement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: individualized rTMS<br>Treatment with the best (highest reduction in tinnitus loudness, most reliable, superior to control condition, most tolerable) protocol as obtained in the test sessions (left vs. right temporoparietal junction, 1Hz, 10Hz, 20Hz, 0.1Hz as active control condition). | Device: repetitive transcranial magnetic stimulation<br>* Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation 2000 pulses intensity of 110% resting motor threshold 10 sessions (daily from Monday to Friday) positioning of coil according to EEG position CP5/CP6<br>|
| Active Comparator: standard rTMS in responders<br>Treatment with standard protocol: left-sided 1Hz in the group of patients who showed temporary reductions in tinnitus loudness in test sessions. | Device: repetitive transcranial magnetic stimulation<br>* Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation 2000 pulses intensity of 110% resting motor threshold 10 sessions (daily from Monday to Friday) positioning of coil according to EEG position CP5/CP6<br>|
| Active Comparator: standard rTMS in non-responders<br>Treatment with standard protocol: left-sided 1Hz in the group of patients who did not show temporary reductions in tinnitus loudness in test sessions. | Device: repetitive transcranial magnetic stimulation<br>* Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation 2000 pulses intensity of 110% resting motor threshold 10 sessions (daily from Monday to Friday) positioning of coil according to EEG position CP5/CP6<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TFI | Tinnitus Functional Index | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TFI | Tinnitus Functional Index | 12 weeks | 
| Mini-TQ | Tinnitus Questionnaire short version | 12 weeks | 
| THI | Tinnitus Handicap inventory | 12 weeks | 
| Tinnitus Severity | Tinnitus numeric Rating scales [0(best) - 10(worst)] | 12 weeks | 
| MDI | Major Depression Inventory | 12 weeks | 
| WHO-QOL BREF | Quality of life [4(worst) - 20(best)] | 12 weeks | 
| CGI | clinical global Impression Change [1(best) - 7(worst)] | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, transcranial magnetic stimulation