Clinical trial NCT01566708: Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Keywords: Acute Tinnitus
Recent Onset Tinnitus
Music Therapy
fMRI
Therapy Evaluation
Lead sponsor: German Center for Music Therapy Research
Sponsor class: OTHER
Collaborators: name: Heidelberg University
name: Clinic of Diagnostic and Interventional Neuroradiology, Saarland University Clinic, Homburg, Germany
First posted: 2012-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment
timeFrame: baseline to week 1 and 12
measure: Tinnitus-Beeinträchtigungs-Fragebogen (TBF-12, Greimel et al. 2000) total score change from baseline to end of treatment
timeFrame: baseline to week 1 and 12
Secondary outcomes:
measure: change in tinnitus frequency
timeFrame: baseline to day 1, 2, 3 and 4 of treatment
measure: change in electro-physiological variables (skin temperature, skin conductance level, pulse frequency, respiration frequency)
timeFrame: baseline to day 1, 2, 3, 4 and 5 of treatment
measure: task-based fMRI: change in neuronal activity from baseline to end of treatment
timeFrame: baseline to week 1
measure: Attention and Performance Self Assessment Scale (APSA, Görtelmeyer et al. 2012) total score change from baseline to end of treatment
timeFrame: baseline to week 1 and 12
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: German Center for Music Therapy Research
state: Baden-Württemberg
Study officials:
affiliation: German Center for Music Therapy Research
name: Hans V Bolay, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: German Center for Music Therapy Research
name: Miriam Grapp
role: PRINCIPAL_INVESTIGATOR
References: