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临床试验/NCT06615531
NCT06615531已完成不适用

Effects of Meditation on Human Well Being

Tobias Moeller-Bertram1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
1
主要终点
Functional brain changes as monitored by functional magnetic resonance imaging (fMRI) following an intensive week-long meditation retreat

研究概览

简要总结

This study will be focused on assessing the molecular, physiological, neuroimaging, and emotional correlates of a week-long intensive meditation retreat experience in a 20-person cohort comprised of healthy participants.

详细描述

Mind-body interventions including meditation, reconceptualization, and placebo have been shown to improve a broad range of physical and mental health outcomes in both healthy and patient populations. How and what humans think about their health has a significant and quantifiable impact.

Placebo effects, another mind-body technique that creates health improvements, have been shown to impact every major organ system. More recently, open-label placebos, placebos administered without concealment such that the subject is aware of the placebo, have been shown to be effective for a host of health conditions. Open-label placebo effects demonstrate that placebo responses are surprisingly not dependent on deception, positive expectation, or conditioning.

Meditation, yet another mind-body intervention, has been shown to reduce pain, inflammation, stress, anxiety, depression, and to improve immune function, and emotional regulation. Different meditation techniques can produce mystical-type experiences-non-ordinary perceptual, cognitive, and affective states in which the distinction between the perceiver and the perceived is transcended. The specific pathways through which meditation promotes physical and mental health are not yet well understood, but meditation-induced changes in neural activity and on the immune and autonomic nervous systems, as well as meditation-induced molecular changes in gene expression and on the proteome and metabolome suggest that these are both broad and profound.

While each of these mind-body interventions has been studied individually, the combination of meditation, reconceptualization, and open label placebo and their combined effect on health, neural activity, and molecular physiology have never been jointly studied. This exploratory observational study will employ psychometric health questionnaires; functional magnetic resonance imaging (fMRI); quantitative electroencephalography (qEEG); and blood plasma-based real time cell metabolic analysis, quantitative assessment of neurite outgrowth, and high-throughput transcriptomics, proteomics, and metabolomics to investigate the joint neural and biological effects of these three mind-body interventions in a 7-day retreat setting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be 21 years of age or older
  • Must speak English
  • Must be a registered attendee of the advanced week-long meditation retreat
  • Must be in generally good health
  • Must agree to provide blood and buccal samples before and after the retreat
  • Must be willing to wear a Garmin device for the entire retreat
  • Must agree to fMRI scans before and after the retreat
  • Must agree to qEEG measurements before, during, and after the retreat
  • Must complete the research consent in its entirety
  • Must be willing to complete self-report surveys for physical and emotional well-being

排除标准

  • Younger than 21 years of age
  • Non-English speaking
  • Not a registered attendee of the advanced week-long meditation retreat
  • Not willing to complete the research consent
  • Has a serious health condition
  • Not willing to provide blood or buccal samples
  • Does not agree to fMRI scans
  • Not willing to wear a Garmin watch
  • Does not agree to qEEG measurements
  • Not willing or able to complete all self-report surveys

结局指标

主要结局

Functional brain changes as monitored by functional magnetic resonance imaging (fMRI) following an intensive week-long meditation retreat

时间窗: 1 week

fMRI scans will be taken on subjects during two conditions (rest and a 15-minute meditation) before and after the week-long retreat to assess changes in brain functional connectivity associated with meditation (meditation vs rest) and resulting from the retreat (pre vs post). It is expected that whole-brain functional connectivity will become more integrated during meditation as well as after the week-long retreat. Resting state network connectivity will be assessed, and it is expected that default mode network (DMN) intra-network connectivity will decrease during meditation and more so post-retreat.

Mystical Experience Questionnaire (MEQ)-30 scores before and after an intensive week-long meditation retreat

时间窗: 1 week

Subjects will be given the MEQ-30 survey following a 15-minute scanner meditation before and after the retreat. An increase in MEQ-30 score is indicative of a higher shift in consciousness and presumably to a more favorable psychological state. Scores will be correlated to functional brain changes.

Brain activity changes as assessed by quantitative EEQ (qEEG) before and after an intensive week-long meditation retreat.

时间窗: 1 week

Brain scans will be collected by qEEG on all subjects during a 15-minute meditation before and after the retreat to assess brain complexity. It is expected that brain complexity will increase after the week-long retreat.

Blood plasma proteomic and metabolomic analysis before and after an intensive week-long meditation retreat.

时间窗: 1 week

An integrative analysis of proteomic and metabolomic expression in blood plasma will be carried out in samples collected before and after the retreat. The expectation is that shifts in biological processes toward an improved state of health will occur after the week-long retreat.

次要结局

  • Effect of meditation-conditioned blood on neurite outgrowth(1 week)
  • Heart rate variability changes during a week-long meditation retreat(1 week)

研究者

发起方
Tobias Moeller-Bertram
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Tobias Moeller-Bertram

President

VitaMed Research LLC

研究点 (1)

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