Integrating Magnetic Imaging With Rich Phenotypes

Completed

• Conditions: Intensive Meditation in Novice and Experienced Meditators
• Interventions: Behavioral: Advanced multi-component meditation practice

• Registration Number: NCT06615531
• Lead Sponsor: Tobias Moeller-Bertram

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-23
• Primary Completion: 2023-05-06
• Study Completion: 2023-05-06
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group study	Advanced multi-component meditation practice	Dr Joe Dispenza Week Long Advanced Retreat Attendees

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of meditation-conditioned blood on neurite outgrowth	1 week	Human plasma collected before and after the retreat will be used to treat differentiated Phaeochromocytoma 12 (PC12) cells. Live cell imaging will be carried out to quantify neurite outgrowth. The expectation is that meditation-conditioned (post-retreat) plasma will lead to greater neurite outgrowth than unconditioned (pre-retreat) plasma.
Heart rate variability changes during a week-long meditation retreat	1 week	Heart rate data will be collected using a Garmin wristwatch at the beginning of the meditation retreat and continuously throughout the week-long retreat. Beat-to-beat interval data will be used to calculate heart rate variability. Time domain measures will include the mean of R-R intervals (mRR), standard deviation of all R-R intervals (SDRR), root mean square of successive R-R differences (RMSSD), and the percentage of R-R intervals that vary by at least 50 ms (pRR50). Frequency domain measures will include very low frequency (VLF), low frequency (LF), and high frequency (HF) measures.

Trial Locations

Locations (1)

VitaMed Research, LLC; 🇺🇸 Palm Desert, California, United States