- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929837
Tinnitus rTMS 2013
August 30, 2016 updated by: Turku University Hospital
Treatment of Tinnitus With Transcranial Magnetic Stimulation
Tinnitus is the perception of sound in the absence of corresponding external sound.
Tinnitus affects approximately 10-15 % of the population.
The prevalence increases with age and it is estimated that more than 20 % of the older people have tinnitus.
Approximately 10-15 % of tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety, depression and sleep disturbances.
The treatment of chronic tinnitus is difficult and most therapies focus on alleviating the condition rather than treating the cause.
Pathophysiology of tinnitus still remains incompletely understood.
Functional brain imaging data in tinnitus patients and animal models suggest that tinnitus is associated with increased neuronal activity, increased synchronicity, and functional reorganization within the auditory cortex either uni- or bilaterally, but there are also functional alterations in brain areas outside the auditory system.
Transcranial magnetic stimulation (TMS) is a neuromodulation technique based on the principle of electromagnetic induction of an electric field in the brain by means of magnetic pulses given to the scalp.
TMS is a non-invasive, painless, and safe method for modulation of cortical activity.
TMS pulses given at low frequencies (≤ 1 Hz) have been shown to decrease cortical excitability both in experimental settings and humans, which forms the basis for using low frequency rTMS to treat chronic tinnitus patients, in whom hyperactivity of the auditory cortex has been observed in functional brain imaging studies
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
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
-
-
Varsinais-Suomi
-
Turku, Varsinais-Suomi, Finland, 20521
- Turku University Hospital
-
-
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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic tinnitus 6 months-10 years
- age 18-65 years
- tinnitus intensity VAS at least 4/10
Exclusion Criteria:
- pulsatile tinnitus
- objective tinnitus
- epilepsy, brain disease
- severe/recent heart disease
- pregnancy
- alcohol abuse
- metallic implants etc.
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: E-fied navigated rTMS
Electrical field navigated transcranial magnetic stimulation
|
1 hz on the superior temporal gyrus contralateral/left side with E-field navigated rTMS (Nexstim) targeted at the tonotopic representation area of the main frequency content of tinnitus
|
Sham Comparator: sham E-field navigated rTMS
Sham electrical field navigated rTMS
|
|
Experimental: non-navigated rTMS
|
1 hz on the superior temporal gyrus contralateral/left side with non-navigated rTMS according to external landmarks (between T3/T4 and P3/P4 EEG-electrode locations)
|
Experimental: Experimental, Navigated rTMS
Navigated rTMS,
|
1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of loudness and pitch of the tinnitus is psychophysically measured, VAS questionnaires, Tinnitus Handicap Inventory, Tinnitus diary
Time Frame: Change from baseline and 2-3 days after treatment period
|
Change from baseline and 2-3 days after treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
September 1, 2013
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
June 24, 2013
First Submitted That Met QC Criteria
August 21, 2013
First Posted (Estimate)
August 28, 2013
Study Record Updates
Last Update Posted (Estimate)
August 31, 2016
Last Update Submitted That Met QC Criteria
August 30, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T69/2013
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
-
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)
-
Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
-
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
-
Cairo UniversityRecruiting
-
University of ZurichRecruitingTinnitus, Subjective | TinnitusSwitzerland
-
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 E-fied navigated rTMS
-
Helsinki University Central HospitalCompletedCentral Post Stroke Pain
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...RecruitingHealthy | Post-stroke DepressionChina
-
Niuvanniemi HospitalActive, not recruitingSchizophrenia | Schizoaffective DisorderFinland
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...RecruitingBinge-Eating Disorder | Bulimia NervosaItaly