Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005571

Trial Description

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Title

Diagnostic and Interventional Study of Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept Using Psychological Assessment and Functional Neuroimaging

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

To date, the pharmacological treatment options for tinnitus are unsatisfactory. For acute
tinnitus drug treatments are only rated as being successful in approximately half of all
cases. Therefore, the purpose of this study is to evaluate a neuro-music therapeutic
approach (the "Heidelberg Model of Music Therapy") as a new treatment option for patients
with recent onset tinnitus after initial medical treatment has failed.

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Brief Summary in Scientific Language

Acute tinnitus is the phenomenon of ringing or buzzing in the ears without an external sound
source that is persisting for a maximum of three month. Several pharmacological treatment
options for acute tinnitus have been established. Nonetheless, after initial medical
intervention, tinnitus symptoms are often persisting and leading to substantial distress.

The objective of the present study is to examine the efficacy of the "Heidelberg Model of
Music Therapy" for patients with recent onset tinnitus whose tinnitus symptoms are enduring
after pharmacological treatment. The "Heidelberg Model of Music Therapy" is a manualized
short term music therapeutic intervention lasting for 9 consecutive 50-minutes sessions of
individualized therapy. It strives for an integration of strategies to manage the
psychological state and possibly restore the underlying neurophysiological reorganisation.
At the basis of this music therapy concept is the notion that tinnitus is experienced as an
auditory percept - just as musical stimuli are experienced as auditory percepts. An
outstanding feature of this treatment approach is the way in which patients actively
influence their symptoms. This leads to an improved self-efficacy and a more differentiated
picture of their symptomatology.

For patients with chronic subjective tinnitus the "Heidelberg Model of Music Therapy" has
proven to be an efficient means to reduce tinnitus distress and loudness. Prior studies
indicate that these positive results are due to the beneficial influence of the music
therapy on the neuronal structures underlying tinnitus pathology.

In the present study the effects of the music therapeutic intervention on tinnitus severity
and tinnitus distress for patients with acute tinnitus are evaluated on the basis of a
battery of psychological tests as well as psycho-physiological measurements. A task-based
functional magnetic resonance imaging (fMRI) paradigm is used to investigate alterations in
neuronal networks supposed to be involved in tinnitus perception and chronification.

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Organizational Data

  •   DRKS00005571
  •   2014/04/01
  •   2012/03/23
  •   yes
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Secondary IDs

  •   NCT01566708  (ClinicalTrials.gov)
  •   CMTR-TA-01  (German Center for Music Therapy Research)
  •   00.181.2011 
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Health Condition or Problem studied

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

  •   Behavioral: Neuro-Music Therapy immediately
  •   Behavioral: Neuro-Music Therapy after waiting time
  •   Behavioral: Music-therapeutical stress management coaching
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment; time frame: baseline to week 1 and 12
- Tinnitus-Beeinträchtigungs-Fragebogen (TBF-12, Greimel et al. 2000) total score change from baseline to end of treatment; time frame: baseline to week 1 and 12

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Secondary Outcome

- change in tinnitus frequency; time frame: baseline to day 1, 2, 3 and 4 of treatment
- change in electro-physiological variables (skin temperature, skin conductance level, pulse frequency, respiration frequency); time frame: baseline to day 1, 2, 3, 4 and 5 of treatment
- task-based fMRI: change in neuronal activity from baseline to end of treatment; time frame: baseline to week 1
- Attention and Performance Self Assessment Scale (APSA, Görtelmeyer et al. 2012) total score change from baseline to end of treatment; time frame: baseline to week 1 and 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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  •   2012/01/31
  •   60
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Clinical diagnosis of acute tinnitus persisting for a maximum of 3 month

- Adults, aged 18 or over

- No contraindication for MRI scan

- Initial medical intervention is accomplished

- Patients are able to understand, read and speak German fluently

- Patients are able to give written informed consent

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Exclusion Criteria

- Clinical diagnosis of chronic tinnitus persisting for longer than 3 month

- Tinnitus related to anatomic lesions of the ear, to retrocochlear lesions or to
cochlear implantation

- Clinical diagnosis of severe mental disorder

- Clinical diagnosis of Menière's Disease

- Severe hyperacusis

- Severe hearing impairment

- Any contraindication for MRI scan

- Initial medical intervention is not accomplished

- Patients are not able to understand, read and speak German fluently

- Patients are not able to give written informed consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • German Center for Music Therapy Research
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    • University Hospital for Ear, Nose, and Throat, University of Heidelberg, Germany
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    • Clinic of Diagnostic and Interventional Neuroradiology, Saarland University Clinic, Homburg, Germany
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    • German Center for Music Therapy Research
    • Hans V Bolay, Prof. Dr. 
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    • German Center for Music Therapy Research
    • Hans V Bolay, Prof. Dr. 
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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 complete, follow-up continuing
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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 .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.