Diagnostic and Interventional Study of Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept Using Psychological Assessment and Functional Neuroimaging
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) total score change from baseline to end of treatment
时间窗: baseline to week 1 and 12
Tinnitus-Beeinträchtigungs-Fragebogen (TBF-12, Greimel et al. 2000) total score change from baseline to end of treatment
时间窗: baseline to week 1 and 12
次要结局
- 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)
- change in tinnitus frequency(baseline to day 1, 2, 3 and 4 of treatment)
- 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)