- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01663324
rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network (Multisite rTMS)
Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Regensburg, Germany, 93053
- University of Regensburg- Dept of Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single site rTMS
Low frequency temporoparietal transcranial magnetic stimulation Intervention: 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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12)
Time Frame: Day 12
|
Day 12
|
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12)
Time Frame: Day 12
|
Day 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame: Day 12
|
Day 12
|
Change in quality of life as measured by the WHOQoL
Time Frame: Day 12
|
Day 12
|
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Time Frame: Day 12
|
Day 12
|
Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90)
Time Frame: Day 90
|
Day 90
|
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Time Frame: Day 12
|
Day 12
|
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Time Frame: Day 90
|
Day 90
|
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Time Frame: Day 180
|
Day 180
|
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame: Day 180
|
Day 180
|
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame: Day 90
|
Day 90
|
Change in quality of life as measured by the WHOQoL
Time Frame: Day 90
|
Day 90
|
Change in quality of life as measured by the WHOQoL
Time Frame: Day 180
|
Day 180
|
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Time Frame: Day 90
|
Day 90
|
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Time Frame: Day 180
|
Day 180
|
Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180)
Time Frame: Day 180
|
Day 180
|
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time Frame: Day 90
|
Day 90
|
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time Frame: Day 180
|
Day 180
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Berthold Langguth, MD, Ph.D., University of Regensburg, Dept of Psychiatry
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uni-Reg-multisite-rTMS-Tin-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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