Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus
NCT ID: NCT01886092
Last Updated: 2018-10-09
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
80 participants
INTERVENTIONAL
2013-05-31
2020-10-31
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
Active rTMS 1
repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects).
Active rTMS2
Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex
Active 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. (20 subjects)
Active rTMS3
Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex
Active rTMS 3
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects)
Sham Condition
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex
sham condition
Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)
Interventions
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Active rTMS 1
repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects).
Active 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. (20 subjects)
Active rTMS 3
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects)
sham condition
Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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, Suh MW. Dual-site rTMS is More Effective than Single-site rTMS in Tinnitus Patients: A Blinded Randomized Controlled Trial. Brain Topogr. 2020 Nov;33(6):767-775. doi: 10.1007/s10548-020-00797-y. Epub 2020 Sep 17.
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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SNUHT1
Identifier Type: OTHER
Identifier Source: secondary_id
H-1212-081-451
Identifier Type: -
Identifier Source: org_study_id
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