Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus

Study Overview
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Brief Summary
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Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways contributing to the perception of phantom sounds, and the regulatory neural network responsible for the generation of the individual amount of suffering caused by chronic tinnitus.

Detailed Description
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Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Low-frequency rTMS applied to the temporoparietal areas has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that taking into account affective components of the multiple overlapping neural networks responsible for the generation of a bothersome subjective tinnitus might enhance the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) treatment in chronic tinnitus. A newly developed coil, the so-called double cone coil will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

Official Title
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Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) With Double-Cone-Coil in Patients With Chronic Tinnitus (Ti-CDC)

Conditions
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Chronic Tinnitus

Intervention / Treatment
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* Device: Medial Frontal rTMS Double-Cone-Coil
* Device: Left DLPFC Butterfly Coil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of bothersome, subjective chronic tinnitus Duration of tinnitus more than 6 months Exclusion Criteria: Objective tinnitus Treatable cause of the tinnitus Involvement in other treatments for tinnitus at the same time Clinically relevant psychiatric comorbidity Clinically relevant unstable internal or neurological comorbidity History of or evidence of significant brain malformation or neoplasm, head injury Cerebral vascular events Neurodegenerative disorder affecting the brain or prior brain surgery; Metal objects in and around body that can not be removed Pregnancy Alcohol or drug abuse Prior treatment with TMS

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 |
| --- | --- |
| Experimental: Medial Frontal rTMS Double-Cone-Coil<br>High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. | Device: Medial Frontal rTMS Double-Cone-Coil<br>* High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.<br>|
| Experimental: Left DLPFC Butterfly Coil<br>High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. | Device: Left DLPFC Butterfly Coil<br>* High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment/ day 12) |  | Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12 |  | Baseline vs. day 90 | 
| Change of depressive symptoms as measured by the Major Depression Inventory (MDI) |  | Baseline vs. day 90 | 
| Change in quality of life as measured by the WHOQoL |  | Baseline vs. day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic tinnitus, subjective tinnitus, double cone coil, rTMS, repetitive transcranial magnetic stimulation