Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of Low Frequency Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Device: Combined frontal and temporal rTMS
* Device: Temporal low frequency rTMS


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined frontal and temporal rTMS<br>Combined low frequency frontal and temporal transcranial magnetic stimulation of auditory cortex and right DLPFC | Device: Combined frontal and temporal rTMS<br>* 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)<br>|
| Experimental: Temporal low frequency rTMS<br>temporal low frequency rTMS of auditory cortex | Device: Temporal low frequency rTMS<br>* Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller |  | Baseline, Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tinnitus, chronic subjective tinnitus, transcranial magnetic stimulation, sensation disorders, hearing disorders