Beth Israel Deaconess Medical Centre
Boston, Massachusetts, 02115, United States
NCT Number: NCT05455814
This study will explore whether a 21-minute meditation practice called Shambhavi Mahamudra Kriya leads to changes in brain health and explore how it affects cognitive and physiological function.
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Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Meditation has been linked to improved brain health and lower brain age. Brain age has been successfully estimated from structural MRI and more recently, EEG Sleep data using Brain Age Index (BAI) derived by machine learning algorithms. Patients with significant neurological or psychiatric disease exhibit a mean excess BAI of about 4 years. Higher BAI is a predictor of mortality. Long term meditation has been associated with lower Brain Age in MRI studies. However, the EEG sleep measure of Brain Age has not been reported in meditators.
This project aims to quantify the progressive impact of meditation on brain age. If established objectively, meditation-based interventions could offer safe, affordable and accessible solutions to promote younger and healthier brains and will have invaluable health and financial implications.
The goal of this project is twofold:
The study intervention is a multi-component 21-minute meditation called Shambhavi Mahamudra Kriya. It is taught at the Inner Engineering program offered by non-profit Isha Foundation as online as well as in-person formats. It incorporates a combination of different breathing patterns and meditative components. The intervention training provides precise, step by step and easy to follow instructions on how to perform this practice. Performed in a seated posture, this is a simple, safe and accessible intervention that requires no previous experience of meditation. The intervention selected for this study was shown to significantly reduce perceived stress, enhance self-reported general well-being, improve positive emotions, mindfulness, sleep, engagement, relationships and may promote enhanced Heart Rate Variability and Sympathovagal balance. The control group will be selected to be age, gender and education level matched with the intervention group and will be asked to continue their daily routine.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Women of childbearing potential will be included as the intervention and the procedures in the study have minimal risks. There will be no enrollment exclusions based on sex, racial or ethnic factors.
If a woman becomes pregnant during the course of the study and is willing to stay as a subject, MRI will not be conducted.
The intervention is taught at the Inner Engineering program offered by non-profit Isha Foundation as online as well as in-person formats. It incorporates a combination of different breathing patterns and meditative components. The intervention training provides precise, step by step and easy to follow instructions on how to perform this practice. Performed in a seated posture, this is a simple, safe and accessible intervention that requires no previous experience of meditation. The intervention selected for this study was shown to significantly reduce perceived stress, enhance self-reported general well-being, improve positive emotions, mindfulness, sleep, engagement, relationships, and may promote enhanced Heart Rate Variability and Sympathovagal balance.
Time frame: Measured at Baseline and 6 months
Frontal Midline Theta Power is obtained from an average of 8 electrodes (Fpc, Fc, Cz, Pz, Oz, F7, F8, P7, P8) around the midline in a standard EEG cap and has been proposed as a correlate of meditation success in previous studies.
Increased value suggests increased control over the brain's default mode network, suggesting more successful meditation experience.
Time frame: Measured at Baseline and 6 months
GSI is an indicator of the Excitation-Inhibition (E-I) balance in the brain and is computed from the power spectral density slope of oscillatory activity in the brain, taking the low-gamma (40-60Hz) band slope of the Power Spectral Density, and is steeper (more negative) when the E-I balance is tipped towards more inhibition.
A higher negative value suggests shift of the brain's excitation/inhibition balance toward more inhibition, indicating a calmer brain.
Time frame: Measured at Baseline and 6 Months
Brain cortical thickness (mm) will be assessed using MRI. Cortical thickness is the width of gray matter in the human cortex. Group-wise comparisons will be made between the intervention group (meditation) and control (no meditation).
A positive difference between the intervention (meditation) and control (no meditation) groups indicates greater cortical thickness in the intervention group.
Time frame: Measured at Baseline and 6 Months
Brain regional volume (mm^3) will be assessed using MRI. Brain regional volume is the volume of brain matter. Group-wise comparisons will be made between the intervention group (meditation) and control (no meditation).
A positive difference between the intervention (meditation) and control (no meditation) groups indicates greater brain volume in the intervention (meditation) group.
Time frame: Measured at Baseline and 6 Months
fMRI is an indirect measure of brain activity based on blood oxygen level dependent (BOLD) signals. Based on BOLD signals, functional connectivity will be assessed. Functional connectivity between two regions will be assessed for both the intervention and control group. A t-statistics value will be calculated based on the differences in signal intensities between the two groups.
A more positive t-statistic indicates greater brain connectivity in the intervention group (meditation) compared to the control (no meditation).
Beth Israel Deaconess Medical Center
Other
Brain Health With Inner Engineering- Longitudinal Study of Shambhavi Mahamudra Kriya Meditation (BLISS)
Acronym: BLISS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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