音乐艺术的认知健康研究 (CHROMA)
CHROMA 项目(音乐艺术认知健康研究)
研究概览
详细说明
大纲:
所有选择参加本研究的合格参与者将被要求完成一次基线访问和一次后续访问。 MCI 参与者将在确认参加研究后被随机分配到实验组(音乐组)或对照组(非音乐组)。
根据评估,研究可能会在不同地点进行。 筛选评估将通过电话和与研究人员面对面进行。 基线和后续评估将在校园内的生物科学研究合作组织 (BRC) 和卫理公会研究所-转化成像中心进行。
评估访问。 有兴趣的人将在莱斯大学生物科学研究合作 (BRC) 大楼 140 号大楼完成第一次访问,以进行基线抽血、健康评估、认知和行为任务以及社交和情感健康评估。 参与者将自行前往或由其看护人或家人带到 BRC 大楼。 基线和后续神经成像将在卫理公会研究所-转化成像中心进行。 此外,参与者和护理人员(如果有)的社交、身体和情感健康将在干预前后通过一系列问卷进行评估。
访问将安排在上午 7:30 到 10:30 之间开始。 研究协调员将提供研究的详细描述、回答问题并获得书面知情同意书。 参与者将完成调查问卷、认知任务和健康评估(测量心率、体重、血压和腰围测量)并抽血。 如果同意参与,护理人员将填写有关社交和情感健康的自我报告问卷。 使用 fMRI 的神经活动将在休斯顿卫理公会医院转化成像中心收集。 完成音乐课程后,参与者将被安排进行一次后续访问。 基线和后续访问在 BRC 应持续约 2-3 小时,在卫理公会影像中心应持续约 1.5 小时。
音乐干预。 实验组的参与者将接受为期 6 周的音乐培训,培训由莱斯牧羊人音乐学院的一名音乐家主持。 音乐干预将在莱斯大学主校区或生物科学研究合作机构进行。 由Brandt博士和Musiqa其他获奖作曲家设计的为期6周的创作音乐课程,将由稻牧音乐学院的研究生作曲家授课。 为了使课程尽可能易于理解,参与者不需要能够阅读乐谱或有任何音乐背景,课程讲师将利用既定方法有效地激发未受过训练的音乐家。 TMC 休斯顿卫理公会医院表演艺术医学中心 (CPAM) 主任 J. Todd Frazier 将协助策划该中心 Margaret Alkek Williams Crain Garden Performance Series 的音乐会,参与者将在音乐会上表演他们的最终作品家人、照顾者和社区成员。 选择的课程和评估计划得到了与 CPAM 合作的关于音乐对神经可塑性的好处的初步工作的支持。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Houston、Texas、美国、77030
- Rice University Bioscience Research Collaborative
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 诊断为早期至中度轻度认知障碍(自我描述并经医生确认)。
- 能够用英语读写
- 握力不低于其年龄组平均水平的 2 个标准差
排除标准:
- 严重的视觉或听觉障碍导致无法阅读和/或听到问卷
- Ⅲ级心力衰竭
- 自身免疫和/或炎症性疾病
- 任何使人无法进行 fMRI 扫描的植入式医疗设备
- 孕妇或哺乳期妇女
- 体重 > 300 磅或 BMI 超过 40
- 专业音乐家
- 被诊断患有并发帕金森病
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:音乐团体
音乐小组中的个人将完成两次评估访问(干预前和干预后)。
在他们的基线访问之后,他们将参加为期6周的小组音乐课,计划每周3天每天2个小时。
每日音乐讲习班将由与赖斯牧羊人音乐学院相关的音乐家领导。
每个星期都会仔细缩放难度,研讨会变得越来越复杂。
例如,第一周的聆听将集中于简短且熟悉的作品,例如器乐和民歌。
逐渐地,讲师将朝着交响乐的运动以及更陌生和实验性的音乐发展。
该课程将最终创建最终组成。
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为期 6 周的团体音乐课程,包括听力、理论、表演和音乐创作。
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无干预:非音乐群体
非音乐组的个人将完成两次分隔2-3个月的评估访问。
他们将被要求在入学期间不参加其他与音乐有关的课程。
参与结束时,将为参与者提供资源来寻找音乐课。
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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 |
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随访时功能性静息状态大脑活动相对于基线的变化。
大体时间:功能磁共振成像将在入学时和完成音乐课程后一个月内获得。
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模块化和灵活性将作为神经活动的量词。
模块化是一组大脑区域内的神经活动比这些组之间的活动更高度相关的程度,灵活性是这些组的动态重组。
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功能磁共振成像将在入学时和完成音乐课程后一个月内获得。
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使用 Guilford 的替代方法使用 Divergent Thinking Test 的分数,创造力水平相对于基线的平均变化
大体时间:创造力将在入学时和完成音乐课程后一个月内进行衡量。
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总分是根据流畅性、灵活性、独创性和阐述性得出的。
分数越高表示创造力越强。
没有最高分。
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创造力将在入学时和完成音乐课程后一个月内进行衡量。
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医疗结果研究的感知社会支持子量表的分数相对于基线的平均变化,包括情感支持、有形支持、深情支持和积极的社会互动。
大体时间:创造力将在入学时和完成音乐课程后一个月内进行衡量。
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分数转换为 0-100 的等级。
自我报告的社会支持量表得分越高,表明在以下每个领域中感知到的社会支持程度越高:情感支持、有形支持、深情支持和积极的社会互动。
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创造力将在入学时和完成音乐课程后一个月内进行衡量。
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SF-36 的每个子量表的生活质量评分相对于基线的平均变化
大体时间:生活质量将在入学时和完成音乐课程后一个月内进行衡量。
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八个衡量生活质量的子量表满分 100 分。
这些分量表包括:身体机能、身体健康导致的角色限制、情绪问题导致的角色限制、精力/疲劳、情绪健康、社会功能、疼痛、一般和健康。
较低的分数表示较大的残疾。
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生活质量将在入学时和完成音乐课程后一个月内进行衡量。
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在 Delis Kaplan 执行功能系统 (DKEFS) 的颜色词干扰测试中,抑制和抑制/转换试验相对于基线的平均变化
大体时间:认知分数将在入学时和完成音乐课程后一个月内进行测量。
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抑制和抑制/转换试验的分数越高表明执行功能越强。
将评估比例分数和原始分数。
没有最低和最高分数。
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认知分数将在入学时和完成音乐课程后一个月内进行测量。
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在韦氏成人智力量表 (WAIS) 的数字跨度测试中,认知分数(数字跨度向前、数字跨度向后、数字跨度排序和总原始分数)相对于基线的平均变化。
大体时间:认知分数将在入学时和完成音乐课程后一个月内进行测量。
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分数越高表明工作记忆能力越强。
每个子量表(前向、后向和排序)的最高分数为 16。
最高总原始分数为 48。
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认知分数将在入学时和完成音乐课程后一个月内进行测量。
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威斯康星卡片分类测试 (WCST) 中持续错误相对于基线的平均变化
大体时间:认知分数将在入学时和完成音乐课程后一个月内进行测量。
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威斯康星卡片分类测试评估执行控制。
WCST 的分数基于所达到的类别、错误和坚持错误的百分比。
持续性错误的数量越多表明执行控制越差。
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认知分数将在入学时和完成音乐课程后一个月内进行测量。
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积极和消极影响量表上影响分数相对于基线的平均变化
大体时间:将在入学后 7 天和音乐课程结束后 1 个月内进行的最终随访后 7 天测量每日影响分数。
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两个衡量积极和消极影响的尺度。
每个量表的分数范围为 10-50。
积极影响量表得分越高表明积极影响水平越高。
负面影响量表得分越低表明负面影响水平越低。
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将在入学后 7 天和音乐课程结束后 1 个月内进行的最终随访后 7 天测量每日影响分数。
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情绪调节量表上情绪调节分数相对于基线的平均变化
大体时间:情绪调节分数将在入学时和完成音乐课程后一个月内进行的随访中进行测量。
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自我报告问卷衡量一个人使用认知评估或抑制技术来调节情绪的程度。
每个子量表的分数越高表明该监管策略的使用越多。
分数是连续的。
情绪重评量表的最高得分为 42 分。
情绪抑制量表的最高得分为 28 分。
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情绪调节分数将在入学时和完成音乐课程后一个月内进行的随访中进行测量。
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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从登记(基线)到随访的炎症平均变化
大体时间:将在入学时和音乐学习完成后一个月内抽血(实验组)。
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血清细胞因子和 C 反应蛋白将作为全身炎症的生物标志物进行评估。
这些特定的细胞因子包括:T 细胞刺激的 IL-6、TNFa、IFNg、IL17a、IL-2。
这些个体促炎生物标志物的体积越大 (pg/mL) 表明炎症水平越高。
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将在入学时和音乐学习完成后一个月内抽血(实验组)。
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合作者和调查者
调查人员
- 首席研究员:Christopher P Fagundes, Ph.D.、William Marsh Rice University
出版物和有用的链接
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