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CompletedNCT01929837Updated Aug 31, 2016

Tinnitus rTMS 2013

An interventional study of E-fied navigated rTMS and non-navigated rTMS in Tinnitus, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-31.

Sponsored by Turku University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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

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Conditions studied

  • Tinnitus

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Keywords

  • Tinnitus
  • Transcranial magnetic stimulation
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In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

Exclusion Criteria:

  • pulsatile tinnitus
  • objective tinnitus
  • epilepsy, brain disease
  • severe/recent heart disease
  • pregnancy
  • alcohol abuse
  • metallic implants etc.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    E-fied navigated rTMS

    Electrical field navigated transcranial magnetic stimulation

    Device: E-fied navigated rTMS

  • 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

  • Experimental
    Experimental, Navigated rTMS

    Navigated rTMS,

    Device: Navigated rTMS

Interventions

  • DeviceE-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

  • Devicenon-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)

  • Devicesham E-field navigated rTMS
  • DeviceNavigated rTMS

    1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor)

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What researchers measure

Primary outcomes

  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

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Study locations

1 site
  • Turku University Hospital
    Turku, Varsinais-Suomi 20521, Finland
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References and documents

Publications

  • Sahlsten H, Taiminen T, Karukivi M, Sjosten N, Nikkila J, Virtanen J, Paavola J, Joutsa J, Niinivirta-Joutsa K, Takala M, Holm A, Rauhala E, Loyttyniemi E, Johansson R, Jaaskelainen SK. Psychiatric (Axis I) and personality (Axis II) disorders and subjective psychiatric symptoms in chronic tinnitus. Int J Audiol. 2018 Apr;57(4):302-312. doi: 10.1080/14992027.2017.1409440. Epub 2017 Nov 30. PubMed 29188734 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01929837
Lead sponsor
Turku University Hospital
Collaborators
Satakunta Central Hospital
Responsible party
Sponsor
First posted
Aug 28, 2013
Start date
Sep 2013
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Aug 31, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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