Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus

Study Overview
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Brief Summary
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Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is registration of sound in the absence of an external or internal acoustic stimulus. It is a common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life. Unfortunately, it is a very difficult symptom to treat because there are hardly any therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the condition 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. Repetitive Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the suppression of tinnitus.

Official Title
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Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus

Conditions
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Tinnitus

Intervention / Treatment
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* Device: transcranial magnetic stimulation (Magstim rapid2)
* Device: sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration. Age ≥18 years Dutch speaking Exclusion Criteria: Treatable cause of the tinnitus Use of anticonvulsant medication or other psychotherapeutic drugs History of epilepsy or family members with epilepsy Presence of active migraine Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy Metal objects in and around body that can not be removed Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test) Alcohol or drug abuse Prior treatment with TMS

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: transcranial magnetic stimulation (Magstim rapid2)<br>* Neuronavigated rTMS will be applied bilaterally to the auditory cortices, which will be identified through a structural MRI scan. Stimulation will be performed with 1 Hz frequency and an intensity of 110% motor threshold for 2000 stimuli (32 minutes) on each side, on five subsequent days.<br>* Other names: Magstim rapid2;|
| Sham Comparator: 2<br> | Device: sham stimulation<br>* The official sham stimulator for the magstim rapid2 will be used. Sham stimulation will follow the same placement protocol and will also last 2x32 minutes on five subsequent days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus severity with the Tinnitus Questionnaire |  | after treatment, 1 week, 1, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory |  | after treatment, 1 week, 1, 3 and 6 months | 
| Beck Depression Inventory |  | after treatment, 1 week, 1, 3 and 6 months | 
| State Trait Anxiety Index |  | after treatment, 1 week, 1, 3 and 6 months | 
| Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems. |  | for the first three months daily and for the second three months monthly | 
| Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition) |  | 1 week after treatment and after 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, transcranial magnetic stimulation