Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Device: Temporal low frequency rTMS; Device: Combined frontal and temporal rTMS

• Registration Number: NCT01261949
• Lead Sponsor: University of Regensburg

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.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis of subjective chronic tinnitus
• Duration of tinnitus more than 3 months

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Temporal low frequency rTMS	Temporal low frequency rTMS	temporal low frequency rTMS of auditory cortex
Combined frontal and temporal rTMS	Combined frontal and temporal rTMS	Combined low frequency frontal and temporal transcranial magnetic stimulation of auditory cortex and right DLPFC

Primary Outcome Measures

Name	Time	Method
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller	Baseline, Day 12

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of Regensburg - Dept of Psychiatry; 🇩🇪 Regensburg, Bayern, Germany