Clinical trial NCT01261949: Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus
Official title: Effectiveness of Low Frequency Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
chronic subjective tinnitus
transcranial magnetic stimulation
sensation disorders
hearing disorders
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
timeFrame: Baseline, Day 12
Secondary outcomes:
measure: Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12
timeFrame: Baseline vs. all follow-up visits
measure: Change of depressive symptoms as measured by the Beck Depression Inventory (BDI)
timeFrame: Baseline vs. all follow-up visits
measure: Change in quality of life as measured by the WHOQoL
timeFrame: Baseline vs. all follow-up visits
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg - Dept of Psychiatry
state: Bayern
Study officials:
affiliation: University of Regensburg - Dep. of Psychiatry
name: Berthold Langguth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kreuzer PM, Landgrebe M, Schecklmann M, Poeppl TB, Vielsmeier V, Hajak G, Kleinjung T, Langguth B. Can Temporal Repetitive Transcranial Magnetic Stimulation be Enhanced by Targeting Affective Components of Tinnitus with Frontal rTMS? A Randomized Controlled Pilot Trial. Front Syst Neurosci. 2011 Nov 4;5:88. doi: 10.3389/fnsys.2011.00088. eCollection 2011.