Tinnitus
Conditions
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)
Interventions
DEVICE1
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
DEVICE2
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.
DEVICE3
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.
DEVICE4
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MEG Asymmetry Index and amplitude of the auditory area | Baseline, After active treatment week |
Secondary
| Measure | Time frame |
|---|---|
| Tinnitus Handicap Inventory (THI) | Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention |
| Visual Analog Scales (VAS) | Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention |
| State-Trait Anxiety Inventory (STAI) | 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 |
| Beck Depression Inventory (BDI) | Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention |
Countries
South Korea
Outcome results
None listed