Clinical trial NCT01874444: Verify the Effectiveness rTMS Using MEG
Official title: Verify the Effectiveness rTMS Using MEG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 28
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: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in MEG Asymmetry Index and amplitude of the auditory area
timeFrame: Baseline, After active treatment week
Secondary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
measure: Visual Analog Scales (VAS)
timeFrame: Baseline, day 3, day 7, day 14, 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: Beck Depression Inventory (BDI)
timeFrame: Baseline, before and after each intervention, 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, 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.