Chronic Tinnitus
Conditions
Keywords
Tinnitus, chronic subjective Tinnitus, transcranial magnetic stimulation, rTMS, hearing disorders
Brief summary
Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception 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. Treatment remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. Additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. Targeting several core regions of this network by rTMS might constitute a promising strategy to enhance treatment effects. A new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.
Interventions
DEVICErTMS intervention 1
Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli. Arms: single site rTMS
DEVICErTMS intervention 2
Repetitive transcranial magnetic stimulation (Magventure Mag Pro Option): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Arms: multisite rTMS
Sponsors
University of Regensburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of subjective chronic tinnitus * THI \> 38 * 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 day 12) | Day 12 |
| Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12) | Day 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change in hyperacusis as measured by the German questionnaire Geräuschüberempfindlichkeitsfragebogen | Day 12 |
| Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90) | Day 90 |
| Change of depressive symptoms as measured by the Major Depression Inventory (MDI) | Day 12 |
| Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180) | Day 180 |
| Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller | Day 90 |
| Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale | Day 12 |
| Change in quality of life as measured by the WHOQoL | Day 12 |
Countries
Germany
Outcome results
None listed