Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

Study Overview
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Brief Summary
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Investigation of objective tinnitus diagnosis method through measurement of continuous resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation (rTMS) treatment of tinnitus.

Detailed Description
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Tinnitus is defined as the subjective perception of a sound in the absence of any physical sound. Therefore, accurate diagnosis of tinnitus is so difficult. So, Investigators measure auditory ERP through autonomously developed system to make a objective diagnosis tinnitus. Moreover, patients undergo continuous resting EEG measurement. In this study investigators examined the efficacy of rTMS treatment for tinnitus and check into changes in brain connectivity or auditory task with ERP, continuous resting EEG before and after rTMS. And develop a new test that can detect tinnitus objectively in humans, using the prepulse gap paradigm

Official Title
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Variable Changes in Continuous Resting EEG(Electroencephalography) and Auditory ERP(Event-related Potential) Before and After Transcranial Magnetic Stimulation Treatment; Double Blind Randomized Controll Trails

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Active rTMS(A)
* Device: Active rTMS(B)
* Device: Sham condition(C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic tinnitus Chronic subjective tinnitus for more than 6 months Subject is naive regarding rTMS Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study Stable enough to complete this study per the opinion of the Study Physician No restrictions, provided the dosages have been in place for at least 3 months A three month washout from any other tinnitus treatment or management program is required prior to entering this study. Exclusion Criteria: Objective tinnitus or tinnitus with treatable cause Presence of intracranial or intraocular ferromagnetic materiel or particles Cardiac pacemaker or other electronic implants (including cochlear implant) Serious heart disease or other unstable major medical condition Personal history of central nervous system disorder, head injury, stroke or seizures Familial history of epilepsy Concomitant medication with antidepressants and antipsychotics Pregnant women Others known contraindications to rTMS or brain MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Active rTMS(A)<br>low frequency frontal and temporal repetitive transcranial magnetic stimulation | Device: Active rTMS(A)<br>* repetitive transcranial magnetic stimulation:1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex , each consisting of 4 days of rTMS treatment. auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train.<br>|
| Experimental: Active rTMS(B)<br>Temporal low frequency repetitive transcranial magnetic stimulation | Device: Active rTMS(B)<br>* repetitive transcranial magnetic stimulation:1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex , each consisting of 4 days of rTMS treatment. auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train.<br>|
| Sham Comparator: Sham condition(C)<br>low frequency frontal and temporal repetitive transcranial magnetic stimulation | Device: Sham condition(C)<br>* The sham stimulation looks and sounds like the active coil, but diverts the magnetic field away from the patient. auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Tinnitus Handicap Inventory (THI) before and after treatment , difference in brain gating and connectivity before and after treatment. |  | Change from Baseline THI at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Visual Analogue Scale (VAS) for tinnitus states before and after treatment. |  | Change from Baseline VAS at 6 months | 
| Positive And Negative Affect Schedule(PANAS) |  | Baseline, 1, 2 and 3 month after the first intervention | 
| Beck's Depression Inventory (BDI) |  | Baseline | 
| State-Trait Anxiety Inventory (STAI) |  | Baseline | 
| Pittsburgh Sleep Quality Index (PSQI) |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinnitus, EEG, ERP