Integrating Magnetic Imaging With Rich Phenotypes | NCT06615531

NCT06615531

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Metamorphosis, LLC	UNKNOWN
University of California, San Diego	OTHER

Description Module

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.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Single group study		Dr Joe Dispenza Week Long Advanced Retreat Attendees	Behavioral: Advanced multi-component meditation practice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Advanced multi-component meditation practice	Behavioral	The study intervention is a multi-component advanced guided meditation practice that incorporates elements of focused attention, non-dual, and loving kindness and compassion meditation techniques as well as breathwork components. The practice includes sitting, lying down, standing, and walking components and is carried out at 7-day advanced meditation retreats lead by Joe Dispenza, D.C. These retreats include lecture-based instruction and up to 35 hours of meditation practice.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional brain changes as monitored by functional magnetic resonance imaging (fMRI) following an intensive week-long meditation retreat	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.	1 week
Mystical Experience Questionnaire (MEQ)-30 scores before and after an intensive week-long meditation retreat	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.	1 week
Brain activity changes as assessed by quantitative EEQ (qEEG) before and after an intensive week-long meditation retreat.	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.	1 week
Blood plasma proteomic and metabolomic analysis before and after an intensive week-long meditation retreat.	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.	1 week

Secondary Outcomes

Measure	Description	Time Frame
Heart rate variability changes during a week-long meditation retreat	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.

Other Outcomes

Measure	Description	Time Frame
Changes in endogenous opioids after an intensive week-long meditation retreat	The levels of endogenous opioids oxytocin, beta-endorphin, dynorphin, and endogenous cannabinoid anandamide will be measured using enzyme-linked immunosorbent assay (ELISA) in pre- and post-retreat blood plasma samples. The expectation is that one or more of these molecules will be elevated after the week-long meditation retreat.

Eligibility Module

Name	Affiliation	Role
Tobias Moeller-Bertram, MD	VitaMed Research LLC	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
VitaMed Research, LLC		Palm Desert	California	92260	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21471390	Background	Zeidan F, Martucci KT, Kraft RA, Gordon NS, McHaffie JG, Coghill RC. Brain mechanisms supporting the modulation of pain by mindfulness meditation. J Neurosci. 2011 Apr 6;31(14):5540-8. doi: 10.1523/JNEUROSCI.5791-10.2011.
32066726	Background	Ng TKS, Fam J, Feng L, Cheah IK, Tan CT, Nur F, Wee ST, Goh LG, Chow WL, Ho RC, Kua EH, Larbi A, Mahendran R. Mindfulness improves inflammatory biomarker levels in older adults with mild cognitive impairment: a randomized controlled trial. Transl Psychiatry. 2020 Jan 21;10(1):21. doi: 10.1038/s41398-020-0696-y.