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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
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

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 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

First Posted
July 19, 2013
Last Updated
March 11, 2015
Sponsor
University of Regensburg
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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
No

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
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.
Intervention Type
Device
Intervention Name(s)
Left DLPFC Butterfly Coil
Intervention 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. Arms: Left DLPFC Butterfly Coil
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
No
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

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Combined rTMS and Relaxation in Chronic Tinnitus

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