Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005514

Trial Description

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Title

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

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Trial Acronym

RELAX

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00005514
  •   2014/01/16
  •   2013/07/19
  •   yes
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Secondary IDs

  •   NCT01907022  (ClinicalTrials.gov)
  •   Uni-Reg-Ti-CDC01-RELAX  (University of Regensburg)
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Health Condition or Problem studied

  •   Chronic Tinnitus
  •   H93.1 -  Tinnitus
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Interventions/Observational Groups

  •   Device: Left DLPFC Butterfly Coil
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
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Primary Outcome

- Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment); time frame: Week 12

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/07/31
  •   30
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

- Diagnosis of bothersome, subjective chronic tinnitus

- Duration of tinnitus more than 6 months

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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

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Addresses

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    • University of Regensburg
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    • University of Regensburg - Dept of Psychiatry
    • Berthold Langguth, MD, Ph.D. 
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    • University of Regensburg - Dept of Psychiatry
    • Berthold Langguth, MD, Ph.D. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.