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MeditationBLISSNCT05455814

Brain Health With Inner Engineering Meditation

A study of Meditation and Brain; Agenesis, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Meditation, Brain; Agenesis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
77 participants
Where
1 siteUnited States
Study dates
6 Jan 2023to 17 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • Beth Israel Deaconess Medical Centre

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Brain Health With Inner Engineering- Longitudinal Study of Shambhavi Mahamudra Kriya Meditation (BLISS)

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.

Read the 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.

Being tested
Shambhavi Madamudra Kriya
Keywords
Functional MRI, EEG, Structural MRI, Shambhavi Mahamudra Kriya, Mindfulness
Medical subject headings
Anencephaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shambhavi Madamudra KriyaBehavioural

    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.

Study groups in NCT05455814
Study groupRoleWhat they receive
Wellness and Meditation-Based InterventionExperimentalShambhavi Mahamudra Kriya: a multi-component 21-minute meditation that incorporates a combination of different breathing patterns and meditative components.
Receives: Behavioral: Shambhavi Madamudra Kriya
ControlNo interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Frontal Midline Theta Power after 6 Months of Daily Meditation Practice

    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.

    Measured: Measured at Baseline and 6 months

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

    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.

    Measured: Measured at Baseline and 6 months

Secondary outcomes (3)
  1. Change in Brain cortical thickness after 6 Months of Daily Meditation Practice

    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.

    Measured: Measured at Baseline and 6 Months

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

    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.

    Measured: Measured at Baseline and 6 Months

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

    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).

    Measured: Measured at Baseline and 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start6 Jan 2023
  3. Primary completion16 Dec 2025
  4. Study completion17 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Factorial
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 blind
Who is masked
Outcomes assessor
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05455814
Sponsor's protocol ID
2022P000296
Acronym
BLISS
Status last verified
May 2026
First submitted
15 Jun 2022
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yordanova J, Kolev V, Mauro F, Nicolardi V, Simione L, Calabrese L, Malinowski P, Raffone A. Common and distinct lateralised patterns of neural coupling during focused attention, open monitoring and loving kindness meditation. Sci Rep. 2020 May 4;10(1):7430. doi: 10.1038/s41598-020-64324-6.

    PubMed 32366919
  • Fox KC, Dixon ML, Nijeboer S, Girn M, Floman JL, Lifshitz M, Ellamil M, Sedlmeier P, Christoff K. Functional neuroanatomy of meditation: A review and meta-analysis of 78 functional neuroimaging investigations. Neurosci Biobehav Rev. 2016 Jun;65:208-28. doi: 10.1016/j.neubiorev.2016.03.021. Epub 2016 Mar 28.

    PubMed 27032724
  • Luders E, Cherbuin N, Gaser C. Estimating brain age using high-resolution pattern recognition: Younger brains in long-term meditation practitioners. Neuroimage. 2016 Jul 1;134:508-513. doi: 10.1016/j.neuroimage.2016.04.007. Epub 2016 Apr 11.

    PubMed 27079530
  • Paixao L, Sikka P, Sun H, Jain A, Hogan J, Thomas R, Westover MB. Excess brain age in the sleep electroencephalogram predicts reduced life expectancy. Neurobiol Aging. 2020 Apr;88:150-155. doi: 10.1016/j.neurobiolaging.2019.12.015. Epub 2019 Dec 23.

    PubMed 31932049
  • Peterson CT, Bauer SM, Chopra D, Mills PJ, Maturi RK. Effects of Shambhavi Mahamudra Kriya, a Multicomponent Breath-Based Yogic Practice ( Pranayama), on Perceived Stress and General Well-Being. J Evid Based Complementary Altern Med. 2017 Oct;22(4):788-797. doi: 10.1177/2156587217730934. Epub 2017 Sep 22.

    PubMed 29228793
  • Muralikrishnan K, Balakrishnan B, Balasubramanian K, Visnegarawla F. Measurement of the effect of Isha Yoga on cardiac autonomic nervous system using short-term heart rate variability. J Ayurveda Integr Med. 2012 Apr;3(2):91-6. doi: 10.4103/0975-9476.96528.

    PubMed 22707866
  • Brandmeyer T, Delorme A. Reduced mind wandering in experienced meditators and associated EEG correlates. Exp Brain Res. 2018 Sep;236(9):2519-2528. doi: 10.1007/s00221-016-4811-5. Epub 2016 Nov 4.

    PubMed 27815577
  • Gao R, Peterson EJ, Voytek B. Inferring synaptic excitation/inhibition balance from field potentials. Neuroimage. 2017 Sep;158:70-78. doi: 10.1016/j.neuroimage.2017.06.078. Epub 2017 Jul 1.

    PubMed 28676297
  • Orekhova EV, Stroganova TA, Schneiderman JF, Lundstrom S, Riaz B, Sarovic D, Sysoeva OV, Brant G, Gillberg C, Hadjikhani N. Neural gain control measured through cortical gamma oscillations is associated with sensory sensitivity. Hum Brain Mapp. 2019 Apr 1;40(5):1583-1593. doi: 10.1002/hbm.24469. Epub 2018 Dec 13.

    PubMed 30549144
  • Kinnunen H, Rantanen A, Kentta T, Koskimaki H. Feasible assessment of recovery and cardiovascular health: accuracy of nocturnal HR and HRV assessed via ring PPG in comparison to medical grade ECG. Physiol Meas. 2020 May 7;41(4):04NT01. doi: 10.1088/1361-6579/ab840a.

    PubMed 32217820
  • Altini M, Kinnunen H. The Promise of Sleep: A Multi-Sensor Approach for Accurate Sleep Stage Detection Using the Oura Ring. Sensors (Basel). 2021 Jun 23;21(13):4302. doi: 10.3390/s21134302.

    PubMed 34201861
  • Wong W. Economic burden of Alzheimer disease and managed care considerations. Am J Manag Care. 2020 Aug;26(8 Suppl):S177-S183. doi: 10.37765/ajmc.2020.88482.

    PubMed 32840331
  • Brandmeyer T, Delorme A. Closed-Loop Frontal Midlinetheta Neurofeedback: A Novel Approach for Training Focused-Attention Meditation. Front Hum Neurosci. 2020 Jun 30;14:246. doi: 10.3389/fnhum.2020.00246. eCollection 2020.

    PubMed 32714171
  • Bruining H, Hardstone R, Juarez-Martinez EL, Sprengers J, Avramiea AE, Simpraga S, Houtman SJ, Poil SS, Dallares E, Palva S, Oranje B, Matias Palva J, Mansvelder HD, Linkenkaer-Hansen K. Measurement of excitation-inhibition ratio in autism spectrum disorder using critical brain dynamics. Sci Rep. 2020 Jun 8;10(1):9195. doi: 10.1038/s41598-020-65500-4.

    PubMed 32513931
  • Arnal PJ, Thorey V, Debellemaniere E, Ballard ME, Bou Hernandez A, Guillot A, Jourde H, Harris M, Guillard M, Van Beers P, Chennaoui M, Sauvet F. The Dreem Headband compared to polysomnography for electroencephalographic signal acquisition and sleep staging. Sleep. 2020 Nov 12;43(11):zsaa097. doi: 10.1093/sleep/zsaa097.

    PubMed 32433768

Questions about this trial

What is this clinical trial studying?

A study of Meditation and Brain; Agenesis, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Frontal Midline Theta Power after 6 Months of Daily Meditation Practice (time frame: Measured at Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05455814, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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