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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Hospital for Ear, Nose, and Throat, University of Heidelberg, Germany
Clinic of Diagnostic and Interventional Neuroradiology, Saarland University Clinic, Homburg, Germany
Information provided by (Responsible Party):
German Center for Music Therapy Research
ClinicalTrials.gov Identifier:
NCT01566708
First received: March 23, 2012
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Tinnitus
Behavioral: Neuro-Music Therapy immediately
Behavioral: Neuro-Music Therapy after waiting time
Behavioral: Music-therapeutical stress management coaching

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

Resource links provided by NLM:


Further study details as provided by German Center for Music Therapy Research:

Primary Outcome Measures:
  • Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment [ Time Frame: baseline to week 1 and 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in tinnitus frequency [ Time Frame: baseline to day 1, 2, 3 and 4 of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • task-based fMRI: change in neuronal activity from baseline to end of treatment [ Time Frame: baseline to week 1 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: September 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566708

Locations
Germany
German Center for Music Therapy Research
Heidelberg, Baden-Württemberg, Germany, 69123
Sponsors and Collaborators
German Center for Music Therapy Research
University Hospital for Ear, Nose, and Throat, University of Heidelberg, Germany
Clinic of Diagnostic and Interventional Neuroradiology, Saarland University Clinic, Homburg, Germany
Investigators
Study Director: Hans V Bolay, Prof. Dr. German Center for Music Therapy Research
Principal Investigator: Miriam Grapp German Center for Music Therapy Research
  More Information

No publications provided

Responsible Party: German Center for Music Therapy Research
ClinicalTrials.gov Identifier: NCT01566708     History of Changes
Other Study ID Numbers: CMTR-TA-01, 00.181.2011
Study First Received: March 23, 2012
Last Updated: April 24, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by German Center for Music Therapy Research:
Acute Tinnitus
Recent Onset Tinnitus
Music Therapy
fMRI
Therapy Evaluation

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014