音乐疗法治疗昏迷性脑损伤患者
2026年4月15日 更新者：C. Michael Dunham、Mercy Health Ohio
音乐疗法用于昏迷脑损伤患者
这项单臂观察性研究的目的是确定早期康复期开始的阿尔法音乐疗法，与历史对照组相比，能否改善严重创伤性脑损伤患者的认知功能。
参与者将通过耳机聆听选定的音乐。
研究者将比较两组在三个时间点的认知功能：ICU出院时、出院时、受伤后三个月。
研究概览
地位
尚未招聘
条件
详细说明
这项单臂观察性研究将纳入在St. Elizabeth Youngstown医院外科重症监护室（ICU）收治的伴有严重创伤性脑损伤的创伤患者。
个体参与将持续7天（14次）或直至从ICU出院，以先发生者为准。
研究预计持续约2年（2026-2028年），招募约20名参与者。
Alpha音乐疗法（AMT）将通过耳机播放，每天两次，每次30分钟，持续7个研究日（共14次），除非提前从ICU出院。
患者监测将在AMT治疗前、治疗期间和治疗后进行。
研究类型
观察性的
注册 (估计的)
35
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。
学习联系方式
- 姓名：C. Michael Dunham, MD
- 电话号码：330-480-3907
- 邮箱：dunham.michael@sbcglobal.net
研究联系人备份
- 姓名：Gregory S Huang, MD
- 电话号码：330-480-3907
- 邮箱：Gregory_Huang@mercy.com
学习地点
-
-
Ohio
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Youngstown、Ohio、美国、44501
- St. Elizabeth Youngstown Hospital
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接触：
- C. Michael Dunham, MD
- 电话号码：330-480-3907
- 邮箱：dunham.michael@sbcglobal.net
-
首席研究员：
- C. Michael Dunham, MD
-
接触：
- Gregory S Huang, MD
- 电话号码：330-480-3907
- 邮箱：Gregory_Huang@mercy.com
-
Youngstown、Ohio、美国、44502
- St. Elizabeth Youngstown Hospital
-
-
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
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
创伤患者，伴有严重创伤性脑损伤，收治于圣伊丽莎白扬斯敦医院外科重症监护室。
描述
入选标准：
- 钝性外伤
- 计算机断层扫描确认颅内出血
- 损伤后格拉斯哥昏迷评分（GCS）3-8分持续48小时以上
- 机械通气
- 年龄≥18岁
- 预计重症监护病房住院时间≥72小时
- 入院第3天联系家属获取同意；如同意，于入院第3天或第4天开始研究
排除标准：
- 考虑候选资格时GCS评分>8
- 即将拔管但无需气管切开
- 怀孕或近期分娩
- 临终关怀
- 穿透性外伤
- 双侧瞳孔固定
- 癌症、晚期肝病、终末期肾病、自身免疫性疾病、既往脑部疾病
- 无法存活的损伤
- 研究者或主治创伤医师认为存在其他原因
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
队列和干预
团体/队列 |
|---|
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匹配的历史对照队列
颅内出血且钝性创伤的患者
|
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α-音乐治疗队列
接受α音乐治疗的创伤性脑损伤昏迷患者
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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 |
|---|---|---|
|
格拉斯哥昏迷量表评分
大体时间：每个研究日的7次后阿尔法音乐 session前后
|
总分范围为3至15分，15分表示患者完全清醒、有定向力，3分表示深度昏迷或死亡。
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每个研究日的7次后阿尔法音乐 session前后
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脑电双频指数
大体时间：Before and after alpha-music sessions on each of the 7 study days
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双频指数值范围从0到100。
数字越低表示镇静程度越深，数字越高表示镇静程度越浅或清醒状态。 |
Before and after alpha-music sessions on each of the 7 study days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
在医院存活或死亡
大体时间：直至研究完成，平均1年
|
患者状态（存活或死亡）
|
直至研究完成，平均1年
|
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重症监护病房住院时长
大体时间：Through study completion, an average of 1 year
|
患者在重症监护室的住院时间
|
Through study completion, an average of 1 year
|
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住院时长
大体时间：通过研究完成，平均为1年
|
患者住院时间
|
通过研究完成，平均为1年
|
|
Following commands
大体时间：出院后3个月时
|
这是一个基于患者是否能遵医嘱而分类为“是”或“否”的类别。
|
出院后3个月时
|
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
- 首席研究员：C. Michael Dunham, MD、St. Elizabeth Youngstown Hospital
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。
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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 (估计的)
2026年4月7日
初级完成 (估计的)
2028年4月7日
研究完成 (估计的)
2028年4月7日
研究注册日期
首次提交
2026年4月2日
首先提交符合 QC 标准的
2026年4月15日
首次发布 (实际的)
2026年4月22日
研究记录更新
最后更新发布 (实际的)
2026年4月22日
上次提交的符合 QC 标准的更新
2026年4月15日
最后验证
2026年4月1日
更多信息
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.