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Completed

NCT Number: NCT00518024

Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of General Psychiatry, University Hospital Tuebingen

Tübingen, D-72072, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjective tinnitus > 6 mo , < 5 ys

Exclusion criteria

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Procedure

Bilateral Theta Burst Stimulation

Primary outcomes

  1. Tinnitus severity (Tinnitus Questionnaire)

    Time frame: after the end of treatment

Secondary outcomes

  1. Visual Analog Scale (Tinnitus Loudness); Visual Analog Scale (Tinnitus Annoyance); Visual Analog Scale (Tinnitus Change); Becks Depression Inventory; Symptom Check List; Audiogram; Speech Audiometry

    Time frame: after end of treatment

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • CenTrial GmbH
  • German Research Foundation

Registry information

Official study title

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

Important dates

First posted
Aug 17, 2007
Registry last updated
Jun 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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