音乐疗法对意识水平的有效性
音乐疗法对神经早期康复患者意识水平的影响调查
It is known that even in patients with severe disorders of consciousness (DOC), the perception of known stimuli triggers emotional reactions that can be interpreted as an expression of a residual function of consciousness. Music therapy has a long tradition in neurological rehabilitation. Frequently, active therapies with own music making and singing are implemented in clinical settings. In DOC patients, it is more likely to use passive music listening. However, findings on effectiveness are limited, as only a few studies have systematically investigated the effects of music therapy in this population. Therefore, the investigators want to investigate the effectiveness of passive listening to preferred music on the level of consciousness.
研究概览
地位
地位
条件
条件
干预/治疗
干预/治疗
详细说明
Due to continuous improvements in acute medical care, the number of patients surviving severe brain damage has increased over the past decades. While some patients improve significantly during the first days after the injury, other patients remain in altered states of consciousness (i.e. coma, unresponsive wakefulness syndrome or minimally conscious state). In patients with disorders of consciousness (DOC), the auditory modality is preferably examined because the responsiveness within the motor and visual modality is often difficult to assess or impaired. Music is a special type of auditory stimulation that can be of particular benefit in DOC patients. The positive effects of music are attributed to the restoration of specific brain networks that are necessary for processing sensory inputs, as well as the emotional aspects of music, which can increase arousal and activate the reward system. Previous studies have shown that music, including passive listening to music, is associated with psychological and physical changes in both healthy and clinical populations. For example, listening to preferred music can reduce pain and anxiety and the need for sedation in different patient groups.
Music therapy has a long tradition in neurological rehabilitation. In DOC patients, passive listening to music is used (in contrast to active therapies used in fully conscious patients). Efficacy results are inconsistent, however, since only a few studies have systematically investigated the effects of music therapy. In previous investigations, either the sample size is very small or no control conditions have been used. A study that met both quality criteria was published by Sun & Chen in 2015. The authors compared two groups: while the music group (n = 20) listened to their favorite music for 15 to 30 minutes three times a day for a period of four weeks, the control group received no stimulation. Although the GCS values increased significantly in both groups, the music group showed a significantly stronger improvement in the level of consciousness. Based on this study, the present study wants to compare the effectiveness of passive listening to music with two control conditions (alternative auditory stimulation and no auditory stimulation) in early neurological rehabilitation patients.
It is a prospective, double-blind, controlled and randomized intervention study that is carried out monocentrically. Over a period of 24 months, 66 patients undergoing early neurological and neurosurgical rehabilitation after severe brain damage are included. For the individual patient, the study duration is a maximum of 38 days (preliminary phase: 3-7 days; intervention phase: 28 days; follow-up phase: 1-3 days). Patients are randomly assigned to one of three study arms (1. Musical stimulation; 2. Alternative auditory stimulation, 3. No auditory stimulation). In the preliminary phase (days 1 to 7), a native MRI (without contrast agent) and a CRS-R assessment are performed. In addition, there is a neurophysiological examination in which evoked potentials are recorded. In the subsequent main phase, the intervention takes place: Over a period of 28 days, the study participants wear headphones for 30 minutes a day, through which they are presented with preferred music (experimental arm), an audio book (comparative arm) or silence (control arm). In the main phase, a CRS-R test is carried out weekly to record the current state of consciousness. In the follow-up phase (1 to 3 days), the (native) MRI examination, the CRS-R assessment and the neurophysiological examination are repeated. The primary outcome measure is an improvement of the level of consciousness, measured with the Coma-Recovery-Scale-Revised (CRS-R).
研究类型
研究类型
注册 (估计的)
注册
阶段
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Hessisch Oldendorf、德国、31840
- BDH-Clinic Hessisch Oldendorf
-
-
参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- early neurological rehabilitation (phase B)
- traumatic brain injury
- disorder of consciousness (coma, UWS, MCS)
- at minimum two weeks after disease onset
- admission to intensive care unit
- written consent from the patient's legal representative
- Exclusion of pregnancy
Exclusion Criteria:
- insufficient cardiorespiratory stability
- fractures or severe infratentorial brain injuries leading to impaired auditory evoked potentials
- previous brain damage
- Known mental disorders (dementia, depression)
- hearing loss or deafness in one or two ears
- wounds that do not allow you to wear headphones
- colonization with multi-resistant pathogens
- MRI contraindications
- claustrophobia
- weight>120 kg
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
手臂数量
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
|
实验性的:Music Stimulation
Patients preferred music is presented via headphones. |
Patients wear headphones for 30 minutes/day over a period of four weeks and listen to their preferred music. |
|
有源比较器:Alternative Auditory Stimulation
An audio book is presented via headphones. |
Patients wear headphones for 30 minutes/day over a period of four weeks and listen to an audio book. |
|
假比较器:No Auditory Stimulation
Silence is presented via headphones. |
Patients wear headphones for 30 minutes/day over a period of four weeks and hear silence. |
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in level of consciousness
大体时间:4 weeks
|
Level of consciousness is measured with the Coma-Recovery-Scale-Revised (Range: 0 to 23) before and after treatment. |
4 weeks
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in connectivity within the default mode network
大体时间:4 weeks
|
Patients undergo a MRI scan before and after intervention. Each MRI scan has a duration of 30 minutes. Functional and structural sequences are measured. The resting-state scan (important for the assessment of the default mode network) has a duration of eight minutes and is performed without external stimulation. |
4 weeks
|
合作者和调查者
调查人员
调查人员
- 研究主任:Jens D Rollnik, MD、BDH-Clinic Hessisch Oldendorf
- 首席研究员:Melanie Boltzmann, PhD、BDH-Clinic Hessisch Oldendorf
出版物和有用的链接
一般刊物
- Kotchoubey B, Pavlov YG, Kleber B. Music in Research and Rehabilitation of Disorders of Consciousness: Psychological and Neurophysiological Foundations. Front Psychol. 2015 Nov 27;6:1763. doi: 10.3389/fpsyg.2015.01763. eCollection 2015.
- Perrin F, Castro M, Tillmann B, Luaute J. Promoting the use of personally relevant stimuli for investigating patients with disorders of consciousness. Front Psychol. 2015 Jul 30;6:1102. doi: 10.3389/fpsyg.2015.01102. eCollection 2015.
- Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
- Sun J, Chen W. Music therapy for coma patients: preliminary results. Eur Rev Med Pharmacol Sci. 2015 Apr;19(7):1209-18.
- Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
研究记录日期
研究主要日期
学习开始 (实际的)
学习开始
初级完成 (估计的)
初级完成
研究完成 (估计的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
其他研究编号
- DOC-MT
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
All IPD that underlie results in a publication.
IPD 共享时间框架
Period of availability begins when results are published, at the earliest in Dec 2022
IPD 共享访问标准
IPD can be obtained from the principal investigator upon reasonable request.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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