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Tinnitus rTMS 2013

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01929837
First Posted: August 28, 2013
Last Update Posted: August 31, 2016
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.
Collaborator:
Satakunta Central Hospital
Information provided by (Responsible Party):
Turku University Hospital
  Purpose
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 Intervention
Tinnitus Device: E-fied navigated rTMS Device: non-navigated rTMS Device: sham E-field navigated rTMS Device: Navigated rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Tinnitus With Transcranial Magnetic Stimulation

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: September 2013
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
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
Finland
Turku University Hospital
Turku, Varsinais-Suomi, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Satakunta Central Hospital
  More Information

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01929837     History of Changes
Other Study ID Numbers: T69/2013
First Submitted: June 24, 2013
First Posted: August 28, 2013
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by Turku University Hospital:
Tinnitus
Transcranial magnetic stimulation

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms