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Tinnitus rTMS 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929837
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : August 31, 2016
Sponsor:
Collaborator:
Satakunta Central Hospital
Information provided by (Responsible Party):
Turku University Hospital

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Tinnitus Device: E-fied navigated rTMS Device: non-navigated rTMS Device: sham E-field navigated rTMS Device: Navigated rTMS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Tinnitus With Transcranial Magnetic Stimulation
Study Start Date : September 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
Experimental: E-fied navigated rTMS
Electrical field navigated transcranial magnetic stimulation
 Device: E-fied navigated rTMS
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
 Device: sham E-field navigated rTMS
Experimental: non-navigated rTMS
non-navigated rTMS
 Device: 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,
 Device: Navigated rTMS
1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01929837


Locations
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Finland
Turku University Hospital
Turku, Varsinais-Suomi, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Satakunta Central Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01929837    
Other Study ID Numbers: T69/2013
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Keywords provided by Turku University Hospital:
Tinnitus
Transcranial magnetic stimulation
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases