University of Regensburg - Dept of Psychiatry
Regensburg, 93053, Germany
NCT Number: NCT01907022
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Regensburg, 93053, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Arms: Left DLPFC Butterfly Coil
Time frame: Week 12
Time frame: Week 4
Time frame: Week 4
Time frame: Week 4
Time frame: Week 2
Time frame: Week 2
Time frame: Week 2
Time frame: Week 4
Time frame: Week 2
Time frame: Week 2
Time frame: Week 4
Time frame: Week 12
Time frame: Week 12
Time frame: Week 12
Time frame: Week 12
University of Regensburg
Other
Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Combination With Relaxation Therapy in Patients With Chronic Tinnitus
Acronym: RELAX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02615600
Chronic Tinnitus, Ear Diseases
Regensburg, Germany
View Trial DetailsNCT07324603
Chronic Tinnitus
Kayseri, Turkey (Türkiye)
View Trial DetailsNCT01407133
Chronic Tinnitus
Lyon, France
View Trial DetailsNCT03550430
Chronic Tinnitus, Ear Diseases
Marburg, Hesse, Germany
View Trial Details