Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept
NCT ID: NCT01566708
Last Updated: 2013-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2012-01-31
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neuro-Music-Therapy for Patients With Chronic Tinnitus - a Controlled Clinical Trial
NCT01845155
Efficacy Study for Development and Use of Neurofeedback-trainings for Patients Suffering From Chronic Tinnitus
NCT02383147
Neurofeedback for Tinnitus - Does Frequency Specificity Matter?
NCT03550430
Neuro-feedback Therapy for Treating Tinnitus
NCT03773926
New Therapy for Patients With Severe Tinnitus
NCT01480193
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
treatment group
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.
waiting list group
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.
control 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heidelberg University
OTHER
Clinic of Diagnostic and Interventional Neuroradiology, Saarland University Clinic, Homburg, Germany
UNKNOWN
German Center for Music Therapy Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hans V Bolay, Prof. Dr.
Role: STUDY_DIRECTOR
German Center for Music Therapy Research
Miriam Grapp
Role: PRINCIPAL_INVESTIGATOR
German Center for Music Therapy Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
German Center for Music Therapy Research
Heidelberg, Baden-Wurttemberg, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00.181.2011
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CMTR-TA-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.