Chronic Tinnitus
Conditions
Keywords
repetitive transcranial magnetic stimulation, chronic tinnitus, relaxation
Brief summary
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
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.
Interventions
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
Sponsors
University of Regensburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment) | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 4 |
| 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 depressive symptoms as measured by the Major Depression Inventory (MDI) | Week 4 |
Countries
Germany
Outcome results
None listed