Brain Health With Inner Engineering Meditation

NCT05455814 | Recruiting

• 1 other identifier: 2022P000296
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Meditation; Brain; Agenesis

Keywords

Functional MRI; EEG; Structural MRI; Shambhavi Mahamudra Kriya; Mindfulness

Outcome Measures

Primary Outcomes (2)

• 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 at Baseline and 6 months

• 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 at Baseline and 6 months

Secondary Outcomes (3)

• Change in Brain cortical thickness after 6 Months of Daily Meditation Practice

  Measured at Baseline and 6 Months

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

  Measured at Baseline and 6 Months

• Change in Brain Connectivity after 6 Months of Daily Meditation Practice

  Measured at Baseline and 6 Months

Study Arms (2)

Wellness and Meditation-Based Intervention

EXPERIMENTAL

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

Behavioral: Shambhavi Madamudra Kriya

Control

NO INTERVENTION

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.

Interventions

Shambhavi Madamudra Kriya BEHAVIORAL

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.

Wellness and Meditation-Based Intervention

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• If a woman becomes pregnant during the course of the study and is willing to stay as a subject, MRI will not be conducted.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (15)

• 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.

  PMID: 32366919 BACKGROUND

• 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.

  PMID: 27032724 BACKGROUND

• 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.

  PMID: 27079530 BACKGROUND

• 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.

  PMID: 31932049 BACKGROUND

• 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.

  PMID: 29228793 BACKGROUND

• 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.

  PMID: 22707866 BACKGROUND

• 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.

  PMID: 27815577 BACKGROUND

• 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.

  PMID: 28676297 BACKGROUND

• 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.

  PMID: 30549144 BACKGROUND

• 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.

  PMID: 32217820 BACKGROUND

• 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.

  PMID: 34201861 BACKGROUND

• 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.

  PMID: 32840331 BACKGROUND

• 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.

  PMID: 32714171 BACKGROUND

• 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.

  PMID: 32513931 BACKGROUND

• 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.

  PMID: 32433768 BACKGROUND

Related Links

• Subramaniam, B. Inner Engineering Yoga Program on Short and Long Term Health Effects (ISHA-Impact): A Longitudinal Study. clinical trials.gov, 2021 Sep. Report No.: NCT04189146.

MeSH Terms

Conditions

Anencephaly

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Abnormalities, Severe Teratoid; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Balachundar Subramaniam, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Balachundar Subramaniam, MD, MPH

CONTACT

617-667-2721; sadhgurucenter_research@bidmc.harvard.edu

Sepideh Hariri, PhD

CONTACT

sadhgurucenter_research@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 13, 2022
• Study Start: January 6, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)