Tinnitus rTMS 2013

Study Overview
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Brief Summary
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Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus affects approximately 10-15 % of the population. The prevalence increases with age and it is estimated that more than 20 % of the older people have tinnitus. Approximately 10-15 % of tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety, depression and sleep disturbances. The treatment of chronic tinnitus is difficult and most therapies focus on alleviating the condition rather than treating the cause. Pathophysiology of tinnitus still remains incompletely understood. Functional brain imaging data in tinnitus patients and animal models suggest that tinnitus is associated with increased neuronal activity, increased synchronicity, and functional reorganization within the auditory cortex either uni- or bilaterally, but there are also functional alterations in brain areas outside the auditory system. Transcranial magnetic stimulation (TMS) is a neuromodulation technique based on the principle of electromagnetic induction of an electric field in the brain by means of magnetic pulses given to the scalp. TMS is a non-invasive, painless, and safe method for modulation of cortical activity. TMS pulses given at low frequencies (≤ 1 Hz) have been shown to decrease cortical excitability both in experimental settings and humans, which forms the basis for using low frequency rTMS to treat chronic tinnitus patients, in whom hyperactivity of the auditory cortex has been observed in functional brain imaging studies

Official Title
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Treatment of Tinnitus With Transcranial Magnetic Stimulation

Conditions
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Tinnitus

Intervention / Treatment
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* Device: E-fied navigated rTMS
* Device: non-navigated rTMS
* Device: sham E-field navigated rTMS
* Device: Navigated rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic tinnitus 6 months-10 years age 18-65 years tinnitus intensity VAS at least 4/10 Exclusion Criteria: pulsatile tinnitus objective tinnitus epilepsy, brain disease severe/recent heart disease pregnancy alcohol abuse metallic implants etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-fied navigated rTMS<br>Electrical field navigated transcranial magnetic stimulation | Device: E-fied navigated rTMS<br>* 1 hz on the superior temporal gyrus contralateral/left side with E-field navigated rTMS (Nexstim) targeted at the tonotopic representation area of the main frequency content of tinnitus<br>|
| Sham Comparator: sham E-field navigated rTMS<br>Sham electrical field navigated rTMS | Device: sham E-field navigated rTMS<br> <br> |
| Experimental: non-navigated rTMS<br>non-navigated rTMS | Device: non-navigated rTMS<br>* 1 hz on the superior temporal gyrus contralateral/left side with non-navigated rTMS according to external landmarks (between T3/T4 and P3/P4 EEG-electrode locations)<br>|
| Experimental: Experimental, Navigated rTMS<br>Navigated rTMS, | Device: Navigated rTMS<br>* 1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of loudness and pitch of the tinnitus is psychophysically measured, VAS questionnaires, Tinnitus Handicap Inventory, Tinnitus diary |  | Change from baseline and 2-3 days after treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinnitus, Transcranial magnetic stimulation