Combined rTMS and Relaxation in Chronic Tinnitus

Study Overview
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Brief Summary
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Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress of phantom sounds.

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. One significant modulator of tinnitus is stress. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. Also non-auditory cortical areas of attention allocation and emotional processing was shown to be involved. Treatment remains difficult. The most effective treatment in chronic tinnitus is cognitive behavioral therapy including elements of relaxation therapy. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporoparietal areas and high-frequency rTMS applied to the left frontal cortex. Newer findings indicate that exercise-combined non-invasive brain stimulation might show superior effects in contrast to rTMS or exercise alone. Combination of relaxation and two-sided (frontal and temporo-parietal) rTMS will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a pilot trial.

Official Title
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Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Combination With Relaxation Therapy in Patients With Chronic Tinnitus

Conditions
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Chronic Tinnitus

Intervention / Treatment
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* 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left dorsolateral prefrontal cortex (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. Relaxation therapy during the 1Hz stimulation with external audio tape instructions. | 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. Relaxation therapy during the 1Hz stimulation with external audio tape instructions. Arms: Left DLPFC Butterfly Coil<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) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller |  | Week 4 | 
| Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) |  | Week 4 | 
| Change of tinnitus severity as measured by the Tinnitus Severity Scale |  | Week 4 | 
| Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller |  | Week 2 | 
| Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) |  | Week 2 | 
| Change of tinnitus severity as measured by the Tinnitus Severity Scale |  | Week 2 | 
| Change of depressive symptoms as measured by the Major Depression Inventory (MDI) |  | Week 4 | 
| Change of depressive symptoms as measured by the Major Depression Inventory (MDI) |  | Week 2 | 
| Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL) |  | Week 2 | 
| Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL) |  | Week 4 | 
| Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller |  | Week 12 | 
| Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) |  | Week 12 | 
| Change of tinnitus severity as measured by the Tinnitus Severity Scale |  | Week 12 | 
| Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL) |  | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repetitive transcranial magnetic stimulation, chronic tinnitus, relaxation