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Clinical Trials/NCT00668720
NCT00668720
Completed
Not Applicable

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus

UMC Utrecht1 site in 1 country52 target enrollmentApril 2008
ConditionsTinnitus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tinnitus
Sponsor
UMC Utrecht
Enrollment
52
Locations
1
Primary Endpoint
Tinnitus severity with the Tinnitus Questionnaire
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is registration of sound in the absence of an external or internal acoustic stimulus. It is a common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life. Unfortunately, it is a very difficult symptom to treat because there are hardly any therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the condition rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Repetitive Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the suppression of tinnitus.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.
  • Age ≥18 years
  • Dutch speaking

Exclusion Criteria

  • Treatable cause of the tinnitus
  • Use of anticonvulsant medication or other psychotherapeutic drugs
  • History of epilepsy or family members with epilepsy
  • Presence of active migraine
  • Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy
  • Metal objects in and around body that can not be removed
  • Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test)
  • Alcohol or drug abuse
  • Prior treatment with TMS

Outcomes

Primary Outcomes

Tinnitus severity with the Tinnitus Questionnaire

Time Frame: after treatment, 1 week, 1, 3 and 6 months

Secondary Outcomes

  • Tinnitus Handicap Inventory(after treatment, 1 week, 1, 3 and 6 months)
  • Beck Depression Inventory(after treatment, 1 week, 1, 3 and 6 months)
  • State Trait Anxiety Index(after treatment, 1 week, 1, 3 and 6 months)
  • Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems.(for the first three months daily and for the second three months monthly)
  • Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition)(1 week after treatment and after 3 and 6 months)

Study Sites (1)

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