Verify the Effectiveness rTMS Using MEG

Not Applicable

• Conditions: Tinnitus
• Interventions: Device: 2; Device: 3; Device: 4; Device: 1

• Registration Number: NCT01874444
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to determine whether rTMS are effective in the treatment of tinnitus

Detailed Description

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)

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-11
• Status Verified: 2013-12
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS2	2	Temporal low frequency rTMS of left primary auditory cortex.
Active rTMS3	3	Frontal low frequency rTMS of left dorsolateral prefrontal cortex .
Sham rTMS4	4	sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.
Active rTMS1	1	Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex .

Primary Outcome Measures

Name	Time	Method
Change in MEG Asymmetry Index and amplitude of the auditory area	Baseline, After active treatment week

Secondary Outcome Measures

Name	Time	Method
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
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
Beck Depression Inventory (BDI)	Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of