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Tinnitus rTMS 2013

T

Turku University Hospital (TYKS)

Status

Completed

Conditions

Tinnitus

Treatments

Device: non-navigated rTMS
Device: Navigated rTMS
Device: E-fied navigated rTMS
Device: sham E-field navigated rTMS

Study type

Interventional

Funder types

Other

Identifiers

NCT01929837
T69/2013

Details and patient eligibility

About

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

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 4 patient groups

E-fied navigated rTMS
Experimental group
Description:
Electrical field navigated transcranial magnetic stimulation
Treatment:
Device: E-fied navigated rTMS
sham E-field navigated rTMS
Sham Comparator group
Description:
Sham electrical field navigated rTMS
Treatment:
Device: sham E-field navigated rTMS
non-navigated rTMS
Experimental group
Description:
non-navigated rTMS
Treatment:
Device: non-navigated rTMS
Experimental, Navigated rTMS
Experimental group
Description:
Navigated rTMS,
Treatment:
Device: Navigated rTMS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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