Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept
|ClinicalTrials.gov Identifier: NCT01566708|
Recruitment Status : Unknown
Verified April 2013 by German Center for Music Therapy Research.
Recruitment status was: Active, not recruiting
First Posted : March 29, 2012
Last Update Posted : April 25, 2013
|Condition or disease||Intervention/treatment|
|Tinnitus||Behavioral: Neuro-Music Therapy immediately Behavioral: Neuro-Music Therapy after waiting time Behavioral: Music-therapeutical stress management coaching|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic and Interventional Study of Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept Using Psychological Assessment and Functional Neuroimaging|
|Study Start Date :||January 2012|
|Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||September 2013|
|Experimental: treatment group||
Behavioral: Neuro-Music Therapy immediately
20 patients are randomized to receive Neuro-Music Therapy immediately. Neuro-Music Therapy takes 5 days and comprises 9 consecutive 50-minutes sessions of individual therapy. Immediately before and after treatment extensive diagnostics are performed, including psychological assessment, functional neuroimaging and electro-physiological examinations.
|Active Comparator: waiting list group||
Behavioral: Neuro-Music Therapy after waiting time
20 Patients were randomized to receive Neuro-Music Therapy after a waiting period not exceeding 6 weeks. Within this waiting time, patients undergo exactly the same diagnostic procedure as the patients of the treatment group.
|Active Comparator: control group||
Behavioral: Music-therapeutical stress management coaching
20 non-tinnitus controls matched in age, gender and hearing ability receive a music-therapeutical stress coaching program. This intervention is based on the main treatment components of the Neuro-Music Therapy for acute tinnitus with alterations of the tinnitus specific elements. Immediately before and after this five-day coaching, controls undergo exactly the same diagnostic procedure as the patients of the treatment group.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566708
|German Center for Music Therapy Research|
|Heidelberg, Baden-Württemberg, Germany, 69123|
|Study Director:||Hans V Bolay, Prof. Dr.||German Center for Music Therapy Research|
|Principal Investigator:||Miriam Grapp||German Center for Music Therapy Research|