Tinnitus
Conditions
Keywords
tinnitus
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.
Interventions
DEVICEActive rTMS 1
repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects).
DEVICEActive rTMS 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. (20 subjects)
DEVICEActive rTMS 3
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects)
DEVICEsham condition
Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) | Change from Baseline inTinnitus Handicap Inventory at 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Beck's Depression Inventory (BDI) | Baseline, before and after each intervention, 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 |
| visual analogue scale (VAS) | Baseline, day 7, day 14, 1, 2 and 3 months after the first intervention |
Countries
South Korea
Outcome results
None listed