- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01874444
Verify the Effectiveness rTMS Using MEG (rTMS)
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of
- Seoul National University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of chronic tinnitus
- 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:
- Objective tinnitus or tinnitus with treatable cause
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active rTMS1
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex .
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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
|
Experimental: Active rTMS2
Temporal low frequency rTMS of left primary auditory cortex.
|
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. |
Experimental: Active rTMS3
Frontal low frequency rTMS of left dorsolateral prefrontal cortex .
|
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 Comparator: Sham rTMS4
sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in MEG Asymmetry Index and amplitude of the auditory area
Time Frame: Baseline, After active treatment week
|
Baseline, After active treatment week
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
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Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
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Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
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Tinnitus Handicap Inventory (THI)
Time Frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
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Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
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Visual Analog Scales (VAS)
Time Frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
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Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
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Beck Depression Inventory (BDI)
Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
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Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Myung-Whan Suh, MD, ph.D, Seoul National University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TN2447
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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