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The purpose of this study is to determine whether rTMS are effective in the treatment of tinnitus
Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. We aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness. Linked to a neuronavigation system that is guided by magnetic resonance imaging (MRI) of the frontal and temporal, rTMS can suppress areas of cortical plasticity. This cortical reorganization can be demonstrated by magnetoencephalography (MEG)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS1 | Experimental | Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex . |
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| Active rTMS2 | Experimental | Temporal low frequency rTMS of left primary auditory cortex. |
|
| Active rTMS3 | Experimental | Frontal low frequency rTMS of left dorsolateral prefrontal cortex . |
|
| Sham rTMS4 | Sham Comparator | sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 | Device | repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 1000 stimuli of 1Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MEG Asymmetry Index and amplitude of the auditory area | Baseline, After active treatment week |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus Handicap Inventory (THI) | Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention | |
| Visual Analog Scales (VAS) | Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention |
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Inclusion Criteria:
Exclusion Criteria:
Personal history of central nervous system disorder, head injury, stroke or seizures
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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 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31830753 | Derived | Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Chung CK, Kim JS, Suh MW. Treatment Outcome of Auditory and Frontal Dual-Site rTMS in Tinnitus Patients and Changes in Magnetoencephalographic Functional Connectivity after rTMS: Double-Blind Randomized Controlled Trial. Audiol Neurootol. 2019;24(6):293-298. doi: 10.1159/000503134. Epub 2019 Dec 12. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 13, 2015 | |
| Reset | Nov 19, 2015 | |
| Release | Oct 16, 2016 | |
| Reset | Dec 7, 2016 | |
| Release | Nov 24, 2017 | |
| Reset | Sep 11, 2018 | |
| Release | Oct 8, 2018 | |
| Reset | Feb 18, 2019 | |
| Release | Feb 27, 2019 | |
| Reset | Jun 4, 2019 | |
| Release | Sep 23, 2019 | |
| Reset | Oct 11, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 13, 2015 | Nov 19, 2015 | |||
| Oct 16, 2016 |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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|
| 2 | Device | repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS. |
|
| 3 | Device | repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left frontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS. |
|
| 4 | Device | Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS. |
|
| State-Trait Anxiety Inventory (STAI) | Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention |
| Beck Depression Inventory (BDI) | Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention |
| Dec 7, 2016 |
| Nov 24, 2017 | Sep 11, 2018 |
| Oct 8, 2018 | Feb 18, 2019 |
| Feb 27, 2019 | Jun 4, 2019 |
| Sep 23, 2019 | Oct 11, 2019 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |