Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus

June 29, 2011 updated by: UMC Utrecht

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus

Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is registration of sound in the absence of an external or internal acoustic stimulus. It is a common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life. Unfortunately, it is a very difficult symptom to treat because there are hardly any therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the condition rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Repetitive Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the suppression of tinnitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

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

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.
  • Age ≥18 years
  • Dutch speaking

Exclusion Criteria:

  • Treatable cause of the tinnitus
  • Use of anticonvulsant medication or other psychotherapeutic drugs
  • History of epilepsy or family members with epilepsy
  • Presence of active migraine
  • Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy
  • Metal objects in and around body that can not be removed
  • Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test)
  • Alcohol or drug abuse
  • Prior treatment with TMS

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
Device: transcranial magnetic stimulation (Magstim rapid2)
Neuronavigated rTMS will be applied bilaterally to the auditory cortices, which will be identified through a structural MRI scan. Stimulation will be performed with 1 Hz frequency and an intensity of 110% motor threshold for 2000 stimuli (32 minutes) on each side, on five subsequent days.
Other Names:
  • Magstim rapid2
Sham Comparator: 2
Device: sham stimulation
The official sham stimulator for the magstim rapid2 will be used. Sham stimulation will follow the same placement protocol and will also last 2x32 minutes on five subsequent days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tinnitus severity with the Tinnitus Questionnaire
Time Frame: after treatment, 1 week, 1, 3 and 6 months
after treatment, 1 week, 1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tinnitus Handicap Inventory
Time Frame: after treatment, 1 week, 1, 3 and 6 months
after treatment, 1 week, 1, 3 and 6 months
Beck Depression Inventory
Time Frame: after treatment, 1 week, 1, 3 and 6 months
after treatment, 1 week, 1, 3 and 6 months
State Trait Anxiety Index
Time Frame: after treatment, 1 week, 1, 3 and 6 months
after treatment, 1 week, 1, 3 and 6 months
Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems.
Time Frame: for the first three months daily and for the second three months monthly
for the first three months daily and for the second three months monthly
Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition)
Time Frame: 1 week after treatment and after 3 and 6 months
1 week after treatment and after 3 and 6 months

Collaborators and Investigators

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

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Bert A van Zanten, AuD, Dept. of Otorhinolaryngology, University Medical Center Utrecht

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 Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (Estimate)

April 29, 2008

Study Record Updates

Last Update Posted (Estimate)

June 30, 2011

Last Update Submitted That Met QC Criteria

June 29, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rTMS_tinnitus_Utrecht

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.

Clinical Trials on Tinnitus

Clinical Trials on transcranial magnetic stimulation (Magstim rapid2)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe