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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Chronic Tinnitus	Device: rTMS intervention 1; Device: rTMS intervention 2	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network
Study Start Date :	July 2012
Actual Primary Completion Date :	August 2014
Actual Study Completion Date :	January 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: single site rTMS; Low frequency temporoparietal transcranial magnetic stimulation Intervention: Device: rTMS intervention 1	Device: rTMS intervention 1; Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli. Arms: single site rTMS
Experimental: multisite rTMS; Combined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation Intervention: Device: rTMS Intervention 2	Device: rTMS intervention 2; Repetitive transcranial magnetic stimulation (Magventure Mag Pro Option): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Arms: multisite rTMS

Outcome Measures

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Primary Outcome Measures :

1. Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12) [ Time Frame: Day 12 ]
2. Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12) [ Time Frame: Day 12 ]

Secondary Outcome Measures :

1. Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 12 ]
2. Change in quality of life as measured by the WHOQoL [ Time Frame: Day 12 ]
3. Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 12 ]
4. Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90) [ Time Frame: Day 90 ]
5. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 12 ]
6. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 90 ]
7. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 180 ]
8. Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 180 ]
9. Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 90 ]
10. Change in quality of life as measured by the WHOQoL [ Time Frame: Day 90 ]
11. Change in quality of life as measured by the WHOQoL [ Time Frame: Day 180 ]
12. Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 90 ]
13. Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 180 ]
14. Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180) [ Time Frame: Day 180 ]
15. Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller [ Time Frame: Day 90 ]
16. Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller [ Time Frame: Day 180 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Diagnosis of subjective chronic tinnitus
• THI > 38
• Duration of tinnitus more than 6 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

Contacts and Locations

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Locations

Germany
University of Regensburg- Dept of Psychiatry
Regensburg, Germany, 93053

Sponsors and Collaborators

University of Regensburg

Investigators

Principal Investigator:	Berthold Langguth, MD, Ph.D.	University of Regensburg, Dept of Psychiatry

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Lehner A, Schecklmann M, Greenlee MW, Rupprecht R, Langguth B. Triple-site rTMS for the treatment of chronic tinnitus: a randomized controlled trial. Sci Rep. 2016 Mar 1;6:22302. doi: 10.1038/srep22302.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lehner A, Schecklmann M, Kreuzer PM, Poeppl TB, Rupprecht R, Langguth B. Comparing single-site with multisite rTMS for the treatment of chronic tinnitus - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial. Trials. 2013 Aug 23;14:269. doi: 10.1186/1745-6215-14-269. Erratum in: Trials. 2014;5:148.

Responsible Party:	Berthold Langguth, MD, Ph.D., MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:	NCT01663324 History of Changes
Other Study ID Numbers:	Uni-Reg-multisite-rTMS-Tin-01
First Posted:	August 13, 2012
Last Update Posted:	May 18, 2016
Last Verified:	May 2016

Keywords provided by Berthold Langguth, MD, Ph.D., University of Regensburg:

Tinnitus; chronic subjective Tinnitus; transcranial magnetic stimulation; rTMS; hearing disorders

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases	Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms