Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

Not Applicable

• Conditions: Tinnitus
• Interventions: Device: Active rTMS 3; Device: sham condition; Device: Active rTMS 1; Device: Active rTMS 2

• Registration Number: NCT01886092
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. The investigators aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-25
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-09
• Primary Completion: 2019-09
• Study Completion: 2020-10

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 rTMS3	Active rTMS 3	Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex
Sham Condition	sham condition	Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex
Active rTMS1	Active rTMS 1	Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex
Active rTMS2	Active rTMS 2	Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex

Primary Outcome Measures

Name	Time	Method
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)	Change from Baseline inTinnitus Handicap Inventory at 3 months

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
Beck's Depression Inventory (BDI)	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
visual analogue scale (VAS)	Baseline, day 7, day 14, 1, 2 and 3 months after the first intervention

Trial Locations

Locations (1)

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