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Combined rTMS and Relaxation in Chronic Tinnitus (RELAX)

Primary Purpose

Chronic Tinnitus

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Left DLPFC Butterfly Coil

About this trial

This is an interventional treatment trial for Chronic Tinnitus focused on measuring repetitive transcranial magnetic stimulation, chronic tinnitus, relaxation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Regensburg - Dept of Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Left dorsolateral prefrontal cortex (DLPFC) Butterfly Coil

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)

Secondary Outcome Measures

Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

Change of tinnitus severity as measured by the Tinnitus Severity Scale

Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

Change of tinnitus severity as measured by the Tinnitus Severity Scale

Change of depressive symptoms as measured by the Major Depression Inventory (MDI)

Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)

Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)

Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

Change of tinnitus severity as measured by the Tinnitus Severity Scale

Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)

Full Information

NCT ID

NCT01907022

First Posted

July 19, 2013

Last Updated

March 11, 2015

Sponsor

University of Regensburg

1. Study Identification

Unique Protocol Identification Number

NCT01907022

Brief Title

Combined rTMS and Relaxation in Chronic Tinnitus

Acronym

RELAX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Regensburg

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Tinnitus

Keywords

repetitive transcranial magnetic stimulation, chronic tinnitus, relaxation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Left dorsolateral prefrontal cortex (DLPFC) Butterfly Coil

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Left DLPFC Butterfly Coil

Intervention Description

Primary Outcome Measure Information:

Title

Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

Time Frame

Week 4

Title

Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

Time Frame

Week 4

Title

Change of tinnitus severity as measured by the Tinnitus Severity Scale

Time Frame

Week 4

Title

Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

Time Frame

Week 2

Title

Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

Time Frame

Week 2

Title

Change of tinnitus severity as measured by the Tinnitus Severity Scale

Time Frame

Week 2

Title

Change of depressive symptoms as measured by the Major Depression Inventory (MDI)

Time Frame

Week 4

Title

Change of depressive symptoms as measured by the Major Depression Inventory (MDI)

Time Frame

Week 2

Title

Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)

Time Frame

Week 2

Title

Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)

Time Frame

Week 4

Title

Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

Time Frame

Week 12

Title

Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

Time Frame

Week 12

Title

Change of tinnitus severity as measured by the Tinnitus Severity Scale

Time Frame

Week 12

Title

Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Berthold Langguth, MD, Ph.D.

Organizational Affiliation

University of Regensburg - Dept of Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Regensburg - Dept of Psychiatry

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Combined rTMS and Relaxation in Chronic Tinnitus

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