Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept
Primary Purpose
Tinnitus
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Neuro-Music Therapy immediately
Neuro-Music Therapy after waiting time
Music-therapeutical stress management coaching
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring Acute Tinnitus, Recent Onset Tinnitus, Music Therapy, fMRI, Therapy Evaluation
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
Sites / Locations
- German Center for Music Therapy Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
treatment group
waiting list group
control group
Arm Description
Outcomes
Primary Outcome Measures
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment
Tinnitus-Beeinträchtigungs-Fragebogen (TBF-12, Greimel et al. 2000) total score change from baseline to end of treatment
Secondary Outcome Measures
change in tinnitus frequency
change in electro-physiological variables (skin temperature, skin conductance level, pulse frequency, respiration frequency)
task-based fMRI: change in neuronal activity from baseline to end of treatment
Attention and Performance Self Assessment Scale (APSA, Görtelmeyer et al. 2012) total score change from baseline to end of treatment
Full Information
NCT ID
NCT01566708
First Posted
March 23, 2012
Last Updated
April 24, 2013
Sponsor
German Center for Music Therapy Research
Collaborators
Heidelberg University, Clinic of Diagnostic and Interventional Neuroradiology, Saarland University Clinic, Homburg, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01566708
Brief Title
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
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Center for Music Therapy Research
Collaborators
Heidelberg University, Clinic of Diagnostic and Interventional Neuroradiology, Saarland University Clinic, Homburg, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Acute Tinnitus, Recent Onset Tinnitus, Music Therapy, fMRI, Therapy Evaluation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Title
waiting list group
Arm Type
Active Comparator
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Neuro-Music Therapy immediately
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neuro-Music Therapy after waiting time
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Music-therapeutical stress management coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment
Time Frame
baseline to week 1 and 12
Title
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
Secondary Outcome Measure Information:
Title
change in tinnitus frequency
Time Frame
baseline to day 1, 2, 3 and 4 of treatment
Title
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
Title
task-based fMRI: change in neuronal activity from baseline to end of treatment
Time Frame
baseline to week 1
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans V Bolay, Prof. Dr.
Organizational Affiliation
German Center for Music Therapy Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Miriam Grapp
Organizational Affiliation
German Center for Music Therapy Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Center for Music Therapy Research
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69123
Country
Germany
12. IPD Sharing Statement
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Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept
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