Combined rTMS and Relaxation in Chronic Tinnitus (RELAX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Regensburg
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:
NCT01907022
First received: July 19, 2013
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Chronic Tinnitus
Device: Left DLPFC Butterfly Coil

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Combination With Relaxation Therapy in Patients With Chronic Tinnitus

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Severity Scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Severity Scale [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Severity Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907022

Locations
Germany
University of Regensburg - Dept of Psychiatry Recruiting
Regensburg, Germany, 93053
Contact: Martin Schecklmann, Dr.    +49 941 941 ext 2054    martin.schecklmann@medbo.de   
Principal Investigator: Berthold Langguth, MD, Ph.D.         
Sub-Investigator: Peter Kreuzer, MD, Dr.         
Sub-Investigator: Timm Pöppl, MD, Dr.         
Sub-Investigator: Martin Schecklmann, Ph.D.         
Sub-Investigator: Astrid Lehner, Dipl. Psych.         
Sponsors and Collaborators
University of Regensburg
Investigators
Principal Investigator: Berthold Langguth, MD, Ph.D. University of Regensburg - Dept of Psychiatry
  More Information

No publications provided

Responsible Party: Berthold Langguth, MD, Ph.D., MD, PhD, University of Regensburg
ClinicalTrials.gov Identifier: NCT01907022     History of Changes
Other Study ID Numbers: Uni-Reg-Ti-CDC01-RELAX
Study First Received: July 19, 2013
Last Updated: July 28, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Regensburg:
repetitive transcranial magnetic stimulation
chronic tinnitus
relaxation

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014