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Brain Health With Inner Engineering Meditation (BLISS)

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ClinicalTrials.gov Identifier: NCT05455814
Recruitment Status : Not yet recruiting
First Posted : July 13, 2022
Last Update Posted : August 23, 2022
Sponsor:
Information provided by (Responsible Party):
Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Meditation Brain; Agenesis Behavioral: Shambhavi Madamudra Kriya Not Applicable

Detailed Description:

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:

  1. In alignment with the recent NCCIH emphasis, we propose this study to combine neuroimaging with other non-neural modalities to delineate the impact of meditation on brain health and overall physiology and to identify objective neural biomarkers to assess meditation-based interventions which could be further used in clinical applications.
  2. It is estimated that by 2050, an unprecedented 18% of the world's population will be above 65 years of age. According to the National Institute on Aging (NIA), aging is the most significant risk factor of many chronic conditions including age-related neurodegenerative diseases, which severely impact the quality of life, healthcare and social costs. The total healthcare cost of Alzheimer's disease in 2020 was estimated at $305 billion and expected to rise to $1 trillion soon. NIA's 5 year strategy highlights the crucial need to better understand the aging brain and develop interventions to address age-related neurological conditions.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This is a prospective cohort study with 40 intervention and 40 matched controls to be followed up for 6 months. Both cohorts will be recruited from meditation-Naïve healthy individuals. The intervention group will learn a 21 minute meditation to practice daily. Various outcomes related to brain health and brain age will be collected over a period of 6 months.
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Brain Health With Inner Engineering- Longitudinal Study of Shambhavi Mahamudra Kriya Meditation (BLISS)
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wellness and Meditation-Based Intervention
Shambhavi Mahamudra Kriya: a multi-component 21-minute meditation that incorporates a combination of different breathing patterns and meditative components.
Behavioral: Shambhavi Madamudra Kriya
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.

No Intervention: Control
Control Group: selected to be age, gender and education level matched with the intervention group and will be asked to continue their daily routine while completing surveys at each timepoint.



Primary Outcome Measures :
  1. Change in Frontal Midline Theta Power after 6 Months of Daily Meditation Practice [ 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.


  2. Change in Gamma Slope Index (GSI) after 6 Months of Daily Meditation [ 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.



Secondary Outcome Measures :
  1. Change in Brain cortical thickness after 6 Months of Daily Meditation Practice [ 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.


  2. Changes in Brain regional volume after 6 Months of Daily Meditation Practice [ 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.


  3. Change in Brain Connectivity after 6 Months of Daily Meditation Practice [ 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals between the ages of 20-65 years.
  • Subjects will be required to be able to understand study instructions and provide informed consent.
  • Currently residing in Massachusetts.

Exclusion Criteria:

  • Non-English Speaking. (Justification: Meditation and cognitive assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)
  • Practicing meditation regularly for the past 6 months (3 or more times per week of practice regularly for the past 6 month).
  • History of psychiatric illness such as severe anxiety, severe depression, Schizophrenia or bipolar disorder.
  • History of any form of cognitive decline or neurological conditions such as dementia, Parkinson's disease, Alzheimer's disease, Huntington's disease, brain tumors, brain surgery.
  • Current use of cognition enhancing drugs
  • Current management for chronic pain.
  • History (within the last 5 years) of stroke/aneurysm.
  • Active history (within the last 5 years) of alcohol or drug abuse (> 10 drinks per week).
  • Current pregnancy or planning to become pregnant in the next 6 months.
  • Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI.
  • Educational attainment below high school level or equivalent.
  • Significant visual impairment.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05455814


Contacts
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Contact: Balachundar Subramaniam, MD, MPH 617-667-2721 sadhgurucenter_research@bidmc.harvard.edu
Contact: Sepideh Hariri, MD, MPH sadhgurucenter_research@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, United States, 02115
Contact: Balachundar Subramaniam, MD, MPH    617-667-2721    sadhgurucenter_research@bidmc.harvard.edu   
Principal Investigator: Balachundar Subramaniam, MD, MPH         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Balachundar Subramaniam, MD, MPH Beth Israel Deaconess Medical Center
Additional Information:
Publications:

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Responsible Party: Balachundhar Subramaniam, Professor of Anesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05455814    
Other Study ID Numbers: 2022P000296
First Posted: July 13, 2022    Key Record Dates
Last Update Posted: August 23, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Balachundhar Subramaniam, Beth Israel Deaconess Medical Center:
FunctionalMRI
EEG
StructuralMRI
Shambhavi Mahamudra Kriya
Mindfulness
Additional relevant MeSH terms:
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Anencephaly
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Abnormalities, Severe Teratoid
Congenital Abnormalities