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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS(A) | Experimental | low frequency frontal and temporal repetitive transcranial magnetic stimulation |
|
| Active rTMS(B) | Experimental | Temporal low frequency repetitive transcranial magnetic stimulation |
|
| Sham condition(C) | Sham Comparator | low frequency frontal and temporal repetitive transcranial magnetic stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rTMS(A) | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myung-Whan Suh, MD, ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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|
| Active rTMS(B) | Device | 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. |
|
| Sham condition(C) | Device | 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. |
|
| Beck's Depression Inventory (BDI) | Baseline |
| State-Trait Anxiety Inventory (STAI) | Baseline |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |