Clinical trial NCT01886092: Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus
Official title: Verification of the Usefulness of the Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
timeFrame: Change from Baseline inTinnitus Handicap Inventory at 3 months
Secondary outcomes:
measure: Beck's Depression Inventory (BDI)
timeFrame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
measure: visual analogue scale (VAS)
timeFrame: Baseline, day 7, day 14, 1, 2 and 3 months after the first intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Myung-Whan Suh, MD, ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.