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

June 28, 2010 updated by: University Hospital Tuebingen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, D-72072
        • Department of General Psychiatry, University Hospital Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjective tinnitus > 6 mo , < 5 ys

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tinnitus severity (Tinnitus Questionnaire)
Time Frame: after the end of treatment
after the end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

German Research Foundation
CenTrial GmbH

Investigators

  • Principal Investigator: Christian Plewnia, M.D., University of Tuebingen, Department of General Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 15, 2007

First Submitted That Met QC Criteria

August 15, 2007

First Posted (Estimate)

August 17, 2007

Study Record Updates

Last Update Posted (Estimate)

June 29, 2010

Last Update Submitted That Met QC Criteria

June 28, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PL 525/1-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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