Clinical trial NCT05455814: Brain Health With Inner Engineering Meditation
Official title: Brain Health With Inner Engineering- Longitudinal Study of Shambhavi Mahamudra Kriya Meditation (BLISS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meditation
Brain; Agenesis
Keywords: Functional MRI
EEG
Structural MRI
Shambhavi Mahamudra Kriya
Mindfulness
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Frontal Midline Theta Power after 6 Months of Daily Meditation Practice
timeFrame: Measured at Baseline and 6 months
measure: Change in Gamma Slope Index (GSI) after 6 Months of Daily Meditation
timeFrame: Measured at Baseline and 6 months
Secondary outcomes:
measure: Change in Brain cortical thickness after 6 Months of Daily Meditation Practice
timeFrame: Measured at Baseline and 6 Months
measure: Changes in Brain regional volume after 6 Months of Daily Meditation Practice
timeFrame: Measured at Baseline and 6 Months
measure: Change in Brain Connectivity after 6 Months of Daily Meditation Practice
timeFrame: Measured at Baseline and 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Balachundar Subramaniam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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