TinnitusNCT01566708
Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept
A study testing Neuro-Music Therapy immediately, Neuro-Music Therapy after waiting time and Music-therapeutical stress management coaching in people with Tinnitus, run by German Center for Music Therapy Research at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Neuro-Music Therapy immediately, Neuro-Music Therapy after waiting time and Music-therapeutical stress management coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Center for Music Therapy Research
Heidelberg, Baden-Wurttemberg, 69123
About this study
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
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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- Neuro-Music Therapy immediately, Neuro-Music Therapy after waiting time, Music-therapeutical stress management coaching
- Keywords
- Acute Tinnitus, Recent Onset Tinnitus, Music Therapy, fMRI, Therapy Evaluation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-Music Therapy immediatelyBehavioural
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 timeBehavioural
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 coachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Behavioral: Neuro-Music Therapy immediately |
| waiting list group | Active comparator | Not described Receives: Behavioral: Neuro-Music Therapy after waiting time |
| control group | Active comparator | Not described Receives: Behavioral: Music-therapeutical stress management coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment
Measured: baseline to week 1 and 12
Tinnitus-Beeinträchtigungs-Fragebogen (TBF-12, Greimel et al. 2000) total score change from baseline to end of treatment
Measured: baseline to week 1 and 12
Secondary outcomes (4)
change in tinnitus frequency
Measured: baseline to day 1, 2, 3 and 4 of treatment
change in electro-physiological variables (skin temperature, skin conductance level, pulse frequency, respiration frequency)
Measured: baseline to day 1, 2, 3, 4 and 5 of treatment
task-based fMRI: change in neuronal activity from baseline to end of treatment
Measured: baseline to week 1
Attention and Performance Self Assessment Scale (APSA, Görtelmeyer et al. 2012) total score change from baseline to end of treatment
Measured: baseline to week 1 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Center for Music Therapy Research
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Clinic of Diagnostic and Interventional Neuroradiology, Saarland University Clinic, Homburg, Germany
- Responsible party
- Sponsor
- Investigators
- Hans V Bolay, Prof. Dr., Study director, German Center for Music Therapy ResearchMiriam Grapp, Principal investigator, German Center for Music Therapy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566708
- Sponsor's protocol ID
- CMTR-TA-01
- Other IDs
- 00.181.2011
- Status last verified
- Apr 2013
- First submitted
- 23 Mar 2012
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01566708
- Acronym / sponsor ID
- CMTR-TA-01
- Conditions
- Tinnitus
- Keywords
- Acute Tinnitus, Recent Onset Tinnitus, Music Therapy, fMRI, Therapy Evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- German Center for Music Therapy ResearchUniversity, hospital or other
- Collaborators
- Heidelberg University, Clinic of Diagnostic and Interventional Neuroradiology, Saarland University Clinic, Homburg, Germany
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Behavioral: Neuro-Music Therapy immediately |
| waiting list group | Active comparator | Behavioral: Neuro-Music Therapy after waiting time |
| control group | Active comparator | Behavioral: Music-therapeutical stress management coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro-Music Therapy immediately20 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. | Behavioural | treatment group |
| Neuro-Music Therapy after waiting time20 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. | Behavioural | waiting list group |
| Music-therapeutical stress management coaching20 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. | Behavioural | control group |
Primary outcome
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment
Time frame: baseline to week 1 and 12
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
4 secondary outcomes
change in tinnitus frequency
Time frame: baseline to day 1, 2, 3 and 4 of treatment
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
task-based fMRI: change in neuronal activity from baseline to end of treatment
Time frame: baseline to week 1
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans V Bolay, Prof. Dr. study director
German Center for Music Therapy Research
Miriam Grapp principal investigator
German Center for Music Therapy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-Music Therapy immediately, Neuro-Music Therapy after waiting time and Music-therapeutical stress management coaching in people with Tinnitus, run by German Center for Music Therapy Research at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment (time frame: baseline to week 1 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2013.