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

This study has been completed.
Sponsor:
Collaborators:
German Research Foundation
CenTrial GmbH
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00518024
First received: August 15, 2007
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Tinnitus
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) in the Treatment of Chronic Tinnitus

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Tinnitus severity (Tinnitus Questionnaire) [ Time Frame: after the end of treatment ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 48
Arms Assigned Interventions
Experimental: 1
Bilateral theta burst stimulation to the secondary auditory cortex
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
Bilateral Theta Burst Stimulation
Experimental: 2
Bilateral theta burst stimulation to the tertiary auditory cortex
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
Bilateral Theta Burst Stimulation
Sham Comparator: 3
Bilateral theta burst stimulation to a non-cortical region
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
Bilateral Theta Burst Stimulation

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjective tinnitus > 6 mo , < 5 ys

Exclusion Criteria:

  • Objective tinnitus
  • Seizures
  • Brain trauma
  • Brain surgery
  • Pacemaker
  • intake of: benzodiazepines, antiepileptics, neuroleptics
  • Suicidality
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00518024

Locations
Germany
Department of General Psychiatry, University Hospital Tuebingen
Tuebingen, Germany, D-72072
Sponsors and Collaborators
University Hospital Tuebingen
German Research Foundation
CenTrial GmbH
Investigators
Principal Investigator: Christian Plewnia, M.D. University of Tuebingen, Department of General Psychiatry
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00518024     History of Changes
Other Study ID Numbers: PL 525/1-1
Study First Received: August 15, 2007
Last Updated: June 28, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
tinnitus
transcranial magnetic stimulation
treatment
cortex

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014