An interventional study of Left DLPFC Butterfly Coil in Chronic Tinnitus, sponsored by University of Regensburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-12.
Sponsored by University of Regensburg · Not applicable, Interventional, and Treatment
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.
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.
412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 339 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →University of Regensburg is the lead sponsor of 67 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)
Time frame: Week 12
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time frame: Week 4
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time frame: Week 4
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Time frame: Week 4
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time frame: Week 2
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time frame: Week 2
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Time frame: Week 2
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 4
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 2
Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)
Time frame: Week 2
Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)
Time frame: Week 4
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time frame: Week 12
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time frame: Week 12
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Time frame: Week 12
Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)
Time frame: Week 12
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University of Regensburg