Overview

This trial is active, not recruiting.

Condition tinnitus
Treatments 1, 2, 3, 4
Sponsor Seoul National University Hospital
Start date May 2013
End date November 2015
Trial size 28 participants
Trial identifier NCT01874444, TN2447

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex .
1
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 1000 stimuli of 1Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS
(Experimental)
Temporal low frequency rTMS of left primary auditory cortex.
2
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.
(Experimental)
Frontal low frequency rTMS of left dorsolateral prefrontal cortex .
3
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left frontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.
(Sham Comparator)
sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.
4
Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.

Primary Outcomes

Measure
Change in MEG Asymmetry Index and amplitude of the auditory area
time frame: Baseline, After active treatment week

Secondary Outcomes

Measure
Tinnitus Handicap Inventory (THI)
time frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
Visual Analog Scales (VAS)
time frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
State-Trait Anxiety Inventory (STAI)
time frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Pittsburgh Sleep Quality Index (PSQI)
time frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Beck Depression Inventory (BDI)
time frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Verify the Effectiveness rTMS Using MEG
Principal investigator Myung-Whan Suh, MD, ph.D
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)
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.