Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus

Study Overview
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Brief Summary
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Tinnitus, i.e., the perception of sounds or noise in the absence of auditory stimuli, is a frequent and often severely disabling symptom of different disorders of the auditory system. There are currently no causal treatments. Using repetitive transcranial magnetic stimulation (rTMS), we have previously demonstrated that the temporoparietal cortex is critically involved in tinnitus perception and that tinnitus can be reduced by rTMS applied to these cortical regions. Therefore, it is reasonable to test rTMS as a potential new treatment strategy against tinnitus. At this stage, small pilot studies indicate some effect on tinnitus impairment but the reduction is predominantly reported to be transient, with high interindividual variability, and questionable clinical relevance. Moreover, the optimal stimulation area is unclear. Here, we use theta burst stimulation (TBS), a new rTMS paradigm for the prolonged modulation of cortical activity. The aim of this study is to test safety and effectivity of 4 weeks of daily bilateral TBS to two cortical areas on chronic tinnitus compared to sham-stimulation.

Official Title
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Safety and Effectiveness of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) in the Treatment of Chronic Tinnitus

Conditions
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Tinnitus

Intervention / Treatment
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* Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjective tinnitus > 6 mo , < 5 ys Exclusion Criteria: Objective tinnitus Seizures Brain trauma Brain surgery Pacemaker intake of: benzodiazepines, antiepileptics, neuroleptics Suicidality

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bilateral theta burst stimulation to the secondary auditory cortex | Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Bilateral Theta Burst Stimulation<br>|
| Experimental: 2<br>Bilateral theta burst stimulation to the tertiary auditory cortex | Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Bilateral Theta Burst Stimulation<br>|
| Sham Comparator: 3<br>Bilateral theta burst stimulation to a non-cortical region | Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Bilateral Theta Burst Stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus severity (Tinnitus Questionnaire) |  | after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (Tinnitus Loudness); Visual Analog Scale (Tinnitus Annoyance); Visual Analog Scale (Tinnitus Change); Becks Depression Inventory; Symptom Check List; Audiogram; Speech Audiometry |  | after end of treatment | 

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