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音乐疗法对意识水平的有效性

2026年9月29日 更新者:BDH-Klinik Hessisch Oldendorf

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

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

介入性

注册 (估计的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Hessisch Oldendorf、德国、31840
        • BDH-Clinic Hessisch Oldendorf

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

武器和干预

参与者组/臂
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

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

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

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月15日

初级完成 (估计的)

2030年6月15日

研究完成 (估计的)

2030年12月15日

研究注册日期

首次提交

2020年6月17日

首先提交符合 QC 标准的

2020年6月19日

首次发布 (实际的)

2020年6月23日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

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

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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