Tinnitus Clinical Trial
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
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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