rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network (Multisite rTMS)
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ClinicalTrials.gov Identifier: NCT01663324 |
Recruitment Status
:
Completed
First Posted
: August 13, 2012
Last Update Posted
: May 18, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Tinnitus | Device: rTMS intervention 1 Device: rTMS intervention 2 | Not Applicable |
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 |

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 |
- Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12) [ Time Frame: Day 12 ]
- Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12) [ Time Frame: Day 12 ]
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 12 ]
- Change in quality of life as measured by the WHOQoL [ Time Frame: Day 12 ]
- Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 12 ]
- Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90) [ Time Frame: Day 90 ]
- Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 12 ]
- Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 90 ]
- Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 180 ]
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 180 ]
- Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 90 ]
- Change in quality of life as measured by the WHOQoL [ Time Frame: Day 90 ]
- Change in quality of life as measured by the WHOQoL [ Time Frame: Day 180 ]
- Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 90 ]
- Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 180 ]
- Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180) [ Time Frame: Day 180 ]
- Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller [ Time Frame: Day 90 ]
- Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller [ Time Frame: Day 180 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663324
Germany | |
University of Regensburg- Dept of Psychiatry | |
Regensburg, Germany, 93053 |
Principal Investigator: | Berthold Langguth, MD, Ph.D. | University of Regensburg, Dept of Psychiatry |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |