Combined rTMS and Relaxation in Chronic Tinnitus (RELAX)

March 11, 2015 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Combination With Relaxation Therapy in Patients With Chronic Tinnitus

Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress of phantom sounds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. One significant modulator of tinnitus is stress. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. Also non-auditory cortical areas of attention allocation and emotional processing was shown to be involved. Treatment remains difficult. The most effective treatment in chronic tinnitus is cognitive behavioral therapy including elements of relaxation therapy. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporoparietal areas and high-frequency rTMS applied to the left frontal cortex. Newer findings indicate that exercise-combined non-invasive brain stimulation might show superior effects in contrast to rTMS or exercise alone. Combination of relaxation and two-sided (frontal and temporo-parietal) rTMS will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a pilot trial.

Study Type

Interventional

Enrollment (Actual)

42

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

  • Germany
      • 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of bothersome, subjective chronic tinnitus
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left dorsolateral prefrontal cortex (DLPFC) Butterfly Coil
High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions.
Device: Left DLPFC Butterfly Coil

High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions.

Arms: Left DLPFC Butterfly Coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame: Week 2
Week 2
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame: Week 4
Week 4
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time Frame: Week 4
Week 4
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time Frame: Week 4
Week 4
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Time Frame: Week 4
Week 4
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time Frame: Week 2
Week 2
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time Frame: Week 2
Week 2
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Time Frame: Week 2
Week 2
Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)
Time Frame: Week 2
Week 2
Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)
Time Frame: Week 4
Week 4
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time Frame: Week 12
Week 12
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time Frame: Week 12
Week 12
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Time Frame: Week 12
Week 12
Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)
Time Frame: Week 12
Week 12

Collaborators and Investigators

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

Sponsor

University of Regensburg

Investigators

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

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, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 19, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Reg-Ti-CDC01-RELAX

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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