Tinnitus
Conditions
Keywords
Tinnitus, chronic subjective tinnitus, transcranial magnetic stimulation, sensation disorders, hearing disorders
Brief summary
Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.
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. Treatment is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by low frequency rTMS of the right dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether low frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.
Interventions
DEVICECombined frontal and temporal rTMS
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 1000 stimuli of 1Hz rTMS over the right DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
DEVICETemporal low frequency rTMS
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)
Sponsors
University of Regensburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of subjective chronic tinnitus * Duration of tinnitus more than 3 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 |
|---|---|
| Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller | Baseline, Day 12 |
Secondary
| Measure | 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. all follow-up visits |
| Change of depressive symptoms as measured by the Beck Depression Inventory (BDI) | Baseline vs. all follow-up visits |
| Change in quality of life as measured by the WHOQoL | Baseline vs. all follow-up visits |
Countries
Germany
Outcome results
None listed