Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

Not Applicable

• Conditions: Tinnitus
• Interventions: Device: Active rTMS(B); Device: Active rTMS(A); Device: Sham condition(C)

• Registration Number: NCT02617953
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Investigation of objective tinnitus diagnosis method through measurement of continuous resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation (rTMS) treatment of tinnitus.

Detailed Description

Tinnitus is defined as the subjective perception of a sound in the absence of any physical sound. Therefore, accurate diagnosis of tinnitus is so difficult.

So, Investigators measure auditory ERP through autonomously developed system to make a objective diagnosis tinnitus. Moreover, patients undergo continuous resting EEG measurement.

In this study investigators examined the efficacy of rTMS treatment for tinnitus and check into changes in brain connectivity or auditory task with ERP, continuous resting EEG before and after rTMS. And develop a new test that can detect tinnitus objectively in humans, using the prepulse gap paradigm

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-09
• Primary Completion: 2020-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Diagnosis of chronic tinnitus
• 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.

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Exclusion Criteria

• Objective tinnitus or tinnitus with treatable cause
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS(B)	Active rTMS(B)	Temporal low frequency repetitive transcranial magnetic stimulation
Active rTMS(A)	Active rTMS(A)	low frequency frontal and temporal repetitive transcranial magnetic stimulation
Sham condition(C)	Sham condition(C)	low frequency frontal and temporal repetitive transcranial magnetic stimulation

Primary Outcome Measures

Name	Time	Method
Change of Tinnitus Handicap Inventory (THI) before and after treatment , difference in brain gating and connectivity before and after treatment.	Change from Baseline THI at 6 months

Secondary Outcome Measures

Name	Time	Method
Change of Visual Analogue Scale (VAS) for tinnitus states before and after treatment.	Change from Baseline VAS at 6 months
Positive And Negative Affect Schedule(PANAS)	Baseline, 1, 2 and 3 month after the first intervention
State-Trait Anxiety Inventory (STAI)	Baseline
Pittsburgh Sleep Quality Index (PSQI)	Baseline
Beck's Depression Inventory (BDI)	Baseline

Trial Locations

Locations (1)

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