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用多模态神经成像研究改变冥想状态下的功能性脑网络

2026年7月21日 更新者:Shanghai Mental Health Center
本研究的目的是通过多模态神经成像研究改变冥想状态下的功能性大脑网络。

研究概览

详细说明

  1. 通过正念训练、海报和网站招募参与者。
  2. 完成问卷、测试和其他实验材料。
  3. 使用多模态神经成像检查冥想练习者内部和外部冥想的功能性脑网络。
  4. 收集和评估有关内部和外部冥想与多模态神经成像的联系的数据,并确定与冥想状态相关的功能。

研究类型

介入性

注册 (实际的)

40

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

    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200030
        • School of Biomedical Engineering, Shanghai Jiao Tong University

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 60年 (成人)

接受健康志愿者

是的

描述

纳入标准:

  • 具有足够的教育水平以了解研究程序并能够与现场人员沟通。
  • 18-60岁。
  • 对冥想感兴趣。
  • 体内无金属或电子植入物;没有假肢(金属牙套、假牙等);没有幽闭恐惧症;没有纹身、穿孔等;实验当天不化妆。
  • 右撇子。

排除标准:

  • 参与者有 MRI 检查禁忌症,例如幽闭恐惧症。
  • 参与者身体不适合进行 MRI,例如有金属植入物。
  • 参与者有神经或精神疾病史,或正在服用任何可能干扰实验的慢性药物。

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:卫生服务研究
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Novice meditators
Participants who have no meditation practice in the previous year and less than 20 entire lifetime hours' meditation.
通过外部冥想教学音频检查外部冥想状态下的 DMN 连接和 CSF 流量。
通过内部冥想教学音频检查外部冥想状态下的 DMN 连接和 CSF 流量。
实验性的:Experienced meditators
Participants with more than two years of mindfulness practice
通过外部冥想教学音频检查外部冥想状态下的 DMN 连接和 CSF 流量。
通过内部冥想教学音频检查外部冥想状态下的 DMN 连接和 CSF 流量。

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
Five Facet Mindfulness Questionnaire(FFMQ)
大体时间:Week 1
FFMQ is a validated, self-administered questionnaire that measures the tendency to act with mindfulness. Its 39 items are assessed on a Likert scale from 1 to 5 (i.e., "never or very rarely true" to "very often or always true"). The higher scores on the scale convey the higher tendency to act with mindfulness.
Week 1
CSF pulsation index
大体时间:Week 1
CSF pulsation index, calculated by the number of CSF pulsation per minute.
Week 1
Functional connectivity
大体时间:Week 1
Checking functional connectivity in major resting-state brain networks (such as DMN).
Week 1

次要结果测量

结果测量
措施说明
大体时间
Mindfulness positive awareness examined by Mindful Attention Awareness Scale (MAAS)
大体时间:Week 1
MAAS is a validated, fifteen-item self-report measure on which the items are scored using a six-point rating scale (1 = almost always and 6 = almost never). The global score of the scale is obtained by calculating the mean score of each participant's responses, and higher scores on the scale convey the higher levels of dispositional mindfulness.
Week 1
The ability of self-compassion examined by Self-Compassion Scale(SCS) after 1-week practice of internal and external mindfulness
大体时间:Week 1
SCS is a validated, 26-item self-report measure on which the items are scored using a five-point Likert scale scored from 1 (almost never) to 5 (almost always). The higher total score on the scale indicates a higher level of self-compassion.
Week 1
Cognitive Flexibility Inventory(CFI)
大体时间:Week 1
CFI is a validated, self-reported measure of cognitive flexibility,which consists of 20 statements scored from 1 ( "definitely disagree") to 7( "definitely agree."). The scores for all items are pooled to generate a total score of 20 to 140. Higher total scores indicate the increasing level of cognitive flexibility.
Week 1
Perceived Stress Scale(PSS)
大体时间:Week 1
PSS is a validated, self-reported measure of psychological stress level. There are 10-items scored from 0 (never) to 4 (very often). The scores for all items are pooled to generate a total score in the range of 0 to 40. Higher total scores indicate the increasing level of psychological stress.
Week 1
The Chinese version of Freiburg Mindfulness Inventory(FMI-13)
大体时间:Week 1
FMI-13 is a validated, thirteen-item self-report measure on which the items are scored using a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). This short form was used for measuring mindfulness traits, and higher scores on the scale convey the higher levels of mindfulness trait.
Week 1

其他结果措施

结果测量
措施说明
大体时间
Cognitive impairment quantitative assessment by Mini-Mental State Examination(MMSE)
大体时间:Week 0
MMSE is a validated, widely used screening tool for cognitive impairment quantitative assessment. It included 11 items. The scores for all items are pooled to generate a total score in the range of 0 to 30. A 27-point was proved to be an appropriate cutoff for cognitive impairment in a population with relatively high educational attainment.
Week 0
Intelligence assessment by Raven's Standard Progressive Matrices (SPM)
大体时间:Week 0
SPM is a validated intelligence assessment that consists of 60 non-colored diagrammatic puzzles with a missing part, which subjects should correctly choose one among six options. SPM scores were estimated as the total of participants' correct answers (0-60). Higher total scores indicate the increasing level of intelligence level.
Week 0
Brief Profile of Mood States(Brief-POMS)
大体时间:Week 1
The Brief-POMS is a validated,30-item measure, with items scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The scores for all items are pooled to generate a total score in the range of 0 to 120. A higher total score on the scale indicates a worse mood state.
Week 1
Mental flexibility assessment by Trail Making Test (TMT)
大体时间:Week 1
TMT is a validated mental flexibility assessment consisting of two parts (TMT-A and TMT-B ). The TMT-A consisted of a standardized page on which the numbers 1 to 25 were scattered within circles. The participants were asked to connect the numbers in order as quickly as possible. Similarly, the TMT-B consisted of a standardized page that included the numbers 1 to 13 and the letters A to L, which were randomly distributed. The participants were instructed to draw lines connecting numbers and letters (ascending and alphabetical) in alternating numbers and letters. A maximum time of 300 s was allowed before discontinuing the test. Direct scores of TMT were the time in seconds taken to complete each task (A and B). A Higher result indicates a worse cognitive outcome.
Week 1

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

  • 学习椅:Qing Fan、Shanghai Mental Health Center
  • 学习椅:Jie Luo、School of Biomedical Engineering, Shanghai Jiao Tong University

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9月20日

初级完成 (实际的)

2023年12月30日

研究完成 (实际的)

2023年12月30日

研究注册日期

首次提交

2021年7月14日

首先提交符合 QC 标准的

2021年8月18日

首次发布 (实际的)

2021年8月25日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年7月21日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • B20200361

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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