Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

Study Overview
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Brief Summary
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Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus

Detailed Description
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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.

Official Title
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Verification of the Usefulness of the Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Tinnitus

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Active rTMS 1
* Device: Active rTMS 2
* Device: Active rTMS 3
* Device: sham condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active rTMS1<br>Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex | Device: Active rTMS 1<br>* 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).<br>|
| Active Comparator: Active rTMS2<br>Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex | Device: Active rTMS 2<br>* 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)<br>|
| Active Comparator: Active rTMS3<br>Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex | Device: Active rTMS 3<br>* 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)<br>|
| Sham Comparator: Sham Condition<br>Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex | Device: sham condition<br>* Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) |  | Change from Baseline inTinnitus Handicap Inventory at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus