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Clinical Trials/NCT00518024
NCT00518024
Completed
Phase 2

Safety and Effectiveness of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) in the Treatment of Chronic Tinnitus

University Hospital Tuebingen1 site in 1 country48 target enrollmentAugust 17, 2007
ConditionsTinnitus

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Tinnitus
Sponsor
University Hospital Tuebingen
Enrollment
48
Locations
1
Primary Endpoint
Tinnitus severity (Tinnitus Questionnaire)
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

Tinnitus, i.e., the perception of sounds or noise in the absence of auditory stimuli, is a frequent and often severely disabling symptom of different disorders of the auditory system. There are currently no causal treatments. Using repetitive transcranial magnetic stimulation (rTMS), we have previously demonstrated that the temporoparietal cortex is critically involved in tinnitus perception and that tinnitus can be reduced by rTMS applied to these cortical regions. Therefore, it is reasonable to test rTMS as a potential new treatment strategy against tinnitus. At this stage, small pilot studies indicate some effect on tinnitus impairment but the reduction is predominantly reported to be transient, with high interindividual variability, and questionable clinical relevance. Moreover, the optimal stimulation area is unclear.

Here, we use theta burst stimulation (TBS), a new rTMS paradigm for the prolonged modulation of cortical activity. The aim of this study is to test safety and effectivity of 4 weeks of daily bilateral TBS to two cortical areas on chronic tinnitus compared to sham-stimulation.

Registry
clinicaltrials.gov
Start Date
August 17, 2007
End Date
TBD
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Subjective tinnitus \> 6 mo , \< 5 ys

Exclusion Criteria

  • Objective tinnitus
  • Brain trauma
  • Brain surgery
  • Pacemaker
  • intake of: benzodiazepines, antiepileptics, neuroleptics
  • Suicidality

Outcomes

Primary Outcomes

Tinnitus severity (Tinnitus Questionnaire)

Time Frame: after the end of treatment

Secondary Outcomes

  • Visual Analog Scale (Tinnitus Loudness); Visual Analog Scale (Tinnitus Annoyance); Visual Analog Scale (Tinnitus Change); Becks Depression Inventory; Symptom Check List; Audiogram; Speech Audiometry(after end of treatment)

Study Sites (1)

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