Effectiveness Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Device: rTMS - Intervention 1; Device: rTMS - Intervention 2

• Registration Number: NCT00876720
• 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 high frequency rTMS of the left dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether high frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-12
• Last Update Posted: 2010-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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
1	rTMS - Intervention 1	Combined frontal and temporal transcranial magnetic stimulation
2	rTMS - Intervention 2	Temporal transcranial magnetic stimulation

Primary Outcome Measures

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

Trial Locations

Locations (1)

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