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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518024
First Posted: August 17, 2007
Last Update Posted: June 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
German Research Foundation
CenTrial GmbH
Information provided by:
University Hospital Tuebingen
August 15, 2007
August 17, 2007
June 29, 2010
Not Provided
Not Provided
Tinnitus severity (Tinnitus Questionnaire) [ Time Frame: after the end of treatment ]
Same as current
Complete list of historical versions of study NCT00518024 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Safety and Effectiveness of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) in the Treatment of Chronic 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Tinnitus
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
Bilateral Theta Burst Stimulation
  • Experimental: 1
    Bilateral theta burst stimulation to the secondary auditory cortex
    Intervention: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
  • Experimental: 2
    Bilateral theta burst stimulation to the tertiary auditory cortex
    Intervention: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
  • Sham Comparator: 3
    Bilateral theta burst stimulation to a non-cortical region
    Intervention: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
Not Provided
Not Provided

Inclusion Criteria:

  • Subjective tinnitus > 6 mo , < 5 ys

Exclusion Criteria:

  • Objective tinnitus
  • Seizures
  • Brain trauma
  • Brain surgery
  • Pacemaker
  • intake of: benzodiazepines, antiepileptics, neuroleptics
  • Suicidality
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00518024
PL 525/1-1
Yes
Not Provided
Not Provided
Not Provided
University Hospital Tuebingen
  • German Research Foundation
  • CenTrial GmbH
Principal Investigator: Christian Plewnia, M.D. University of Tuebingen, Department of General Psychiatry
University Hospital Tuebingen
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP