rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network

Not Applicable

Completed

• Conditions: Chronic Tinnitus
• Interventions: Device: rTMS intervention 2; Device: rTMS intervention 1

• Registration Number: NCT01663324
• Lead Sponsor: University of Regensburg

Brief Summary

Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.

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 remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. Additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. Targeting several core regions of this network by rTMS might constitute a promising strategy to enhance treatment effects. A new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-13
• Primary Completion: 2014-08
• Study Completion: 2015-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

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

Inclusion Criteria

• Diagnosis of subjective chronic tinnitus
• THI > 38
• Duration of tinnitus more than 6 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
multisite rTMS	rTMS intervention 2	Combined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation Intervention: Device: rTMS Intervention 2
single site rTMS	rTMS intervention 1	Low frequency temporoparietal transcranial magnetic stimulation Intervention: Device: rTMS intervention 1

Primary Outcome Measures

Name	Time	Method
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12)	Day 12
Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12)	Day 12

Secondary Outcome Measures

Name	Time	Method
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"	Day 180
Change in quality of life as measured by the WHOQoL	Day 180
Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90)	Day 90
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale	Day 180
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)	Day 90
Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180)	Day 180
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller	Day 180

Trial Locations

Locations (1)

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