Tinnitus rTMS 2013

This study is ongoing, but not recruiting participants.
Satakunta Central Hospital
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
First received: June 24, 2013
Last updated: April 20, 2016
Last verified: April 2016
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
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2013
Estimated Study Completion Date: August 2016
Estimated 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)


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01929837

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 
Study First Received: June 24, 2013
Last Updated: April 20, 2016
Health Authority: Finland: Ethics Committee

Keywords provided by Turku University Hospital:
Transcranial magnetic stimulation

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

ClinicalTrials.gov processed this record on May 26, 2016