Neuro-Music-Therapy for Patients With Chronic Tinnitus - a Controlled Clinical Trial

Tinnitus Clinical Trial

Official title:

Neuro-Music-Therapy for Patients With Chronic Tinnitus - a Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845155
• Other study ID #: CMTR-TC-02
• Status: Completed
• Phase: N/A
• First received: April 24, 2013
• Last updated: February 19, 2014
• Start date: March 2006
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: German Center for Music Therapy Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

BACKGROUND: Tinnitus is a nonspecific symptom of hearing disorder characterized by the sensation of buzzing, ringing, clicking, pulsations, and other noises in the ear. Despite a variety of treatments, many patients with chronic tinnitus ask for more active ways in coping with their tinnitus. Gold standard treatment in chronic tinnitus is a comprehensive directive counseling explaining the underlying mechanisms leading to the tinnitus percept. Therefore a neuro-music therapeutic treatment based on a bio-psycho-social framework was developed and compared to a counselling-only control group.

INTERVENTION: two standardized protocols for tinnitus therapy were defined ("neuro-music therapy" vs. "counselling")

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of chronic tinnitus persisting for a minimum of 6 month

• Adults, aged 18 or over

• Patients are able to understand, read and speak German fluently

• Patients are able to give written informed consent

• tinnitus with determinable centre frequency

Exclusion Criteria:

• Tinnitus related to anatomic lesions of the ear, to retrocochlear lesions or to cochlear implantation

• Tinnitus is concomitant symptom of a known systemic disease (such as Menière's Disease, vestibular schwannoma, endolymphatic hydrops)

• Status following craniocerebral trauma, cervicogenic or stomatognathic tinnitus

• Tinnitus is neither noisiform nor tonal (cricking, clacking, rumbling) or has different sound components or is pulsatile, intermittent or non-persistent

• Severe hearing impairment (greater than 50 decibel hearing loss (dB HL) in the region of the centre tinnitus frequency)

• Severe hyperacusis

• One or two sided deafness

• Clinical diagnosis of severe mental disorder or psychiatric or neurological disease (psychosis, epilepsy, Parkinsons's disease, dementia, alcohol or drug abuse)

• History of severe ischemic disorder (previous stoke, previous heart attack, peripheral arterial occlusion disease)

• Inability to discontinue drugs known to be associated with tinnitus (high-dose aspirin, quinidine, aminoglycosides) or psychotropic medication prior to entry into the study

• Patients are not able to understand, read and speak German fluently

• Patients are not able to give written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• Neuro-Music-Therapy according to the Heidelberg Model
The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning. For more details on the music therapy see Argstatter et al. 2012
• Counselling
Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.

Locations

Country	Name	City	State
Germany	German Center for Music Therapy Research	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
German Center for Music Therapy Research

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Argstatter H, Grapp M, Hutter E, Plinkert P, Bolay HV. Long-term effects of the "Heidelberg Model of Music Therapy" in patients with chronic tinnitus. Int J Clin Exp Med. 2012;5(4):273-88. Epub 2012 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment	Tinnitus severity was assessed by the German version of the tinnitus questionnaire (TQ, Goebel and Hiller 1994). The TQ consists of a total of 52 items. The questionnaire records tinnitus related complaints on a global TQ-score. The range of values is between the minimum score of 0 and the maximum score of 84, whereas high values indicate high tinnitus related distress.	average time period was 3 months	No
Secondary	Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)		the average time period was 3 months	No