Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
28 participants
INTERVENTIONAL
2013-05-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active rTMS1
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex .
1
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
Active rTMS2
Temporal low frequency rTMS of left primary auditory cortex.
2
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.
Active rTMS3
Frontal low frequency rTMS of left dorsolateral prefrontal cortex .
3
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.
Sham rTMS4
sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.
4
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.
Interventions
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1
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
2
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* Chronic subjective tinnitus for more than 6 months
* Pure tone average \<50 dB HL in the ear where tinnitus is perceived
* Dominant tinnitus frequency measured between 4 and 8 kHz
* 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
* Absolute thresholds \> 60 dB on individual frequencies up to 8 kHz
* 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
* Severe depression
* Severe anxiety
* Others known contraindications to rTMS or brain MRI
18 Years
70 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Myung-Whan Suh, MD, ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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TN2447
Identifier Type: -
Identifier Source: org_study_id