Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept
Diagnostic and Interventional Study of Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept Using Psychological Assessment and Functional Neuroimaging
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 23, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedApril 25, 2013
April 1, 2013
1.2 years
March 23, 2012
April 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment
baseline to week 1 and 12
Tinnitus-Beeinträchtigungs-Fragebogen (TBF-12, Greimel et al. 2000) total score change from baseline to end of treatment
baseline to week 1 and 12
Secondary Outcomes (4)
change in tinnitus frequency
baseline to day 1, 2, 3 and 4 of treatment
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
task-based fMRI: change in neuronal activity from baseline to end of treatment
baseline to week 1
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
Study Arms (3)
treatment group
EXPERIMENTALwaiting list group
ACTIVE COMPARATORcontrol group
ACTIVE COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
German Center for Music Therapy Research
Heidelberg, Baden-Wurttemberg, 69123, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hans V Bolay, Prof. Dr.
German Center for Music Therapy Research
- PRINCIPAL INVESTIGATOR
Miriam Grapp
German Center for Music Therapy Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2012
First Posted
March 29, 2012
Study Start
January 1, 2012
Primary Completion
April 1, 2013
Study Completion
September 1, 2013
Last Updated
April 25, 2013
Record last verified: 2013-04