- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01261949
Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus
January 7, 2016 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg
Effectiveness of Low Frequency Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 low frequency rTMS of the right dorsolateral prefrontal cortex (DLPFC).
In the proposed study we investigate whether low frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bayern
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Regensburg, Bayern, Germany
- University of Regensburg - Dept of Psychiatry
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of subjective chronic tinnitus
- Duration of tinnitus more than 3 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Combined frontal and temporal rTMS
Combined low frequency frontal and temporal transcranial magnetic stimulation of auditory cortex and right DLPFC
|
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 1000 stimuli of 1Hz rTMS over the right DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
|
Experimental: Temporal low frequency rTMS
temporal low frequency rTMS of auditory cortex
|
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
Time Frame: Baseline, Day 12
|
Baseline, Day 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12
Time Frame: Baseline vs. all follow-up visits
|
Baseline vs. all follow-up visits
|
Change of depressive symptoms as measured by the Beck Depression Inventory (BDI)
Time Frame: Baseline vs. all follow-up visits
|
Baseline vs. all follow-up visits
|
Change in quality of life as measured by the WHOQoL
Time Frame: Baseline vs. all follow-up visits
|
Baseline vs. all follow-up visits
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Berthold Langguth, MD, University of Regensburg - Dep. of Psychiatry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 16, 2010
First Submitted That Met QC Criteria
December 16, 2010
First Posted (Estimate)
December 17, 2010
Study Record Updates
Last Update Posted (Estimate)
January 8, 2016
Last Update Submitted That Met QC Criteria
January 7, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uni-Reg-rTMS-Tinnitus-02
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.
Clinical Trials on Tinnitus
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State University of New York at BuffaloUniversity at BuffaloCompletedTinnitus, Subjective | Tinnitus | Noise Induced Tinnitus | Tinnitus, Objective | Tinnitus Aggravated | Tinnitus, Pulsatile | Tinnitus, Spontaneous Oto-Acoustic Emission | Tinnitus, Clicking | Tinnitus, Tensor Tympani InducedUnited States
-
Mohab MohammedNot yet recruitingPulsatile Tinnitus (Diagnosis)
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Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
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University of GuadalajaraHospital Civil de Guadalajara; Institute of Experimental and Clinical TherapeuticsRecruitingOxidative Stress | Tinnitus, Subjective | Tinnitus, Bilateral | Antioxidant Therapy | Psychiatric Drugs | Inflammatory Cytokines | SSRIMexico
-
University Hospital, BordeauxNot yet recruiting
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Cairo UniversityRecruiting
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University of ZurichRecruitingTinnitus, Subjective | TinnitusSwitzerland
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Eye & ENT Hospital of Fudan UniversityNot yet recruiting
-
University of Illinois at Urbana-ChampaignGN Hearing A/SActive, not recruitingTinnitus, SubjectiveUnited States
-
University of ZurichCompletedTinnitus, SubjectiveGermany, Switzerland
Clinical Trials on Combined frontal and temporal rTMS
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University of Sao Paulo General HospitalActive, not recruitingTraumatic Brain Injury | Post-Concussion SymptomsBrazil
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University of RegensburgCompletedChronic TinnitusGermany
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University of RegensburgCompleted
-
The Hong Kong Polytechnic UniversityThe University of Hong KongCompletedDiabetic Macular Oedema | Parafoveal ScotomaChina
-
Tianjin Anding HospitalChinese Academy of SciencesEnrolling by invitationSchizophrenia Negative TypeChina
-
University of MinnesotaCompleted
-
Shanghai Mental Health CenterHuashan Hospital; Tongji HospitalCompletedMajor Depressive DisorderChina
-
University of OxfordLondon School of Hygiene and Tropical Medicine; The Leeds Teaching Hospitals... and other collaboratorsCompletedGiant Cell ArteritisIreland, United Kingdom, Germany, Norway, Portugal
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University of AarhusTerminatedDepressive DisorderDenmark