Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus

N/ACompletedNCT01261949

University of Regensburg50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tinnitus

Interventions

Combined frontal and temporal rTMSDEVICE

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)

Temporal low frequency rTMSDEVICE

Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Regensburg - Dept of Psychiatry

Regensburg, Bavaria, Germany

Outcomes

Primary Outcomes

Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller

Time frame: Baseline, Day 12

Secondary Outcomes

Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12

Time frame: Baseline vs. all follow-up visits

Change of depressive symptoms as measured by the Beck Depression Inventory (BDI)

Time frame: Baseline vs. all follow-up visits

Change in quality of life as measured by the WHOQoL

Time frame: Baseline vs. all follow-up visits

Data from ClinicalTrials.gov

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