Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01566708
• Other study ID #: CMTR-TA-01
• Secondary ID: 00.181.2011
• Status: Active, not recruiting
• Phase: N/A
• First received: March 23, 2012
• Last updated: April 24, 2013
• Start date: January 2012
• Est. completion date: September 2013

Study information

• Verified date: April 2013
• Source: German Center for Music Therapy Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	German Center for Music Therapy Research	Heidelberg	Baden-Württemberg

Sponsors (3)

Lead Sponsor	Collaborator
German Center for Music Therapy Research	Clinic of Diagnostic and Interventional Neuroradiology, Saarland University Clinic, Homburg, Germany, Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment		baseline to week 1 and 12	No
Primary	Tinnitus-Beeinträchtigungs-Fragebogen (TBF-12, Greimel et al. 2000) total score change from baseline to end of treatment		baseline to week 1 and 12	No
Secondary	change in tinnitus frequency		baseline to day 1, 2, 3 and 4 of treatment	No
Secondary	change in electro-physiological variables (skin temperature, skin conductance level, pulse frequency, respiration frequency)		baseline to day 1, 2, 3, 4 and 5 of treatment	Yes
Secondary	task-based fMRI: change in neuronal activity from baseline to end of treatment		baseline to week 1	Yes
Secondary	Attention and Performance Self Assessment Scale (APSA, Görtelmeyer et al. 2012) total score change from baseline to end of treatment		baseline to week 1 and 12	No