Brain Health With Inner Engineering Meditation (BLISS)

Beth Israel Lahey Health

Status: Enrolling

Conditions: Meditation; Brain; Agenesis

Treatments: Behavioral: Shambhavi Madamudra Kriya

Study type: Interventional

Funder types: Other

Identifiers

NCT05455814

2022P000296

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Wellness and Meditation-Based Intervention

Experimental group

Description:

Shambhavi Mahamudra Kriya: a multi-component 21-minute meditation that incorporates a combination of different breathing patterns and meditative components.

Treatment:

Behavioral: Shambhavi Madamudra Kriya

Control

No Intervention group

Description:

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.