rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network (Multisite rTMS)

May 17, 2016 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg

Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network

Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.

Study Overview

Status

Completed

Conditions

Detailed Description

Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. Additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. Targeting several core regions of this network by rTMS might constitute a promising strategy to enhance treatment effects. A new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

Study Type

Interventional

Enrollment (Actual)

50

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

      • Regensburg, Germany, 93053
        • University of Regensburg- Dept of Psychiatry

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of subjective chronic tinnitus
  • THI > 38
  • Duration of tinnitus more than 6 months

Exclusion Criteria:

  • Objective tinnitus
  • Treatable cause of the tinnitus
  • Involvement in other treatments for tinnitus at the same time
  • Clinically relevant psychiatric comorbidity
  • Clinically relevant unstable internal or neurological comorbidity
  • History of or evidence of significant brain malformation or neoplasm, head injury
  • Cerebral vascular events
  • Neurodegenerative disorder affecting the brain or prior brain surgery;
  • Metal objects in and around body that can not be removed
  • Pregnancy
  • 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: single site rTMS

Low frequency temporoparietal transcranial magnetic stimulation

Intervention: Device: rTMS intervention 1

Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli.

Arms: single site rTMS

Experimental: multisite rTMS

Combined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation

Intervention: Device: rTMS Intervention 2

Repetitive transcranial magnetic stimulation (Magventure Mag Pro Option): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold).

Arms: multisite rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12)
Time Frame: Day 12
Day 12
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12)
Time Frame: Day 12
Day 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame: Day 12
Day 12
Change in quality of life as measured by the WHOQoL
Time Frame: Day 12
Day 12
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Time Frame: Day 12
Day 12
Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90)
Time Frame: Day 90
Day 90
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Time Frame: Day 12
Day 12
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Time Frame: Day 90
Day 90
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Time Frame: Day 180
Day 180
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame: Day 180
Day 180
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame: Day 90
Day 90
Change in quality of life as measured by the WHOQoL
Time Frame: Day 90
Day 90
Change in quality of life as measured by the WHOQoL
Time Frame: Day 180
Day 180
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Time Frame: Day 90
Day 90
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Time Frame: Day 180
Day 180
Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180)
Time Frame: Day 180
Day 180
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time Frame: Day 90
Day 90
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time Frame: Day 180
Day 180

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Berthold Langguth, MD, Ph.D., University of Regensburg, Dept of 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.

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

July 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

August 8, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

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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