Meditation for Brain Health

(BLISS Trial)

Overseen By Balachundar Subramaniam, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Cognition enhancers

Disqualifiers: Severe anxiety, Depression, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test if a 21-minute meditation called Shambhavi Mahamudra Kriya can improve brain health and overall well-being. The study targets people interested in better brain function and reduced stress. The meditation uses specific breathing and meditation techniques to help achieve these benefits. Shambhavi Mahamudra Kriya is a multicomponent breath-based yogic practice that has been shown to reduce perceived stress and improve general well-being after regular practice.

Will I have to stop taking my current medications?

The trial requires that you are not currently using cognition enhancing drugs or being managed for chronic pain. If you are taking these types of medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Shambhavi Madamudra Kriya for brain health?

Research shows that meditation can lead to positive changes in brain areas related to attention, memory, and executive function, which are important for brain health. Studies on similar meditation practices have found improvements in memory, reduced stress, and increased brain volume in areas at risk in neurodegenerative diseases. ^{1 2 3 4 5}

Is meditation generally safe for humans?

Meditation is generally considered safe for most people, but some studies have reported potential side effects, including mental health issues. It's important to be aware of these risks and consult with a healthcare provider if you have concerns. ^{6 7 8 9 10}

How is the treatment Shambhavi Madamudra Kriya different from other treatments for brain health?

Shambhavi Madamudra Kriya is a meditation practice that may help improve brain health by reducing stress, which is a factor in neurodegeneration and Alzheimer's disease. Unlike other treatments, it focuses on meditation's potential to enhance cognitive function and well-being, similar to Kirtan Kriya, which has shown benefits like improved memory and reduced anxiety. ^{1 4 11 12 13}

Research Team

Balachundar Subramaniam, MD, MPH

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for Massachusetts residents aged 20-65 who can understand the study and consent to participate. It's not for pregnant individuals, non-English speakers, those with less than a high school education, or anyone in another study that could affect results. People with recent substance abuse, significant visual impairment, history of certain neurological issues or psychiatric illnesses are also excluded.

Inclusion Criteria

Currently residing in Massachusetts

I am between 20 and 65 years old.

Subjects must be able to understand study instructions and provide informed consent

Exclusion Criteria

Current pregnancy or planning to become pregnant in the next 6 months

I have been practicing meditation regularly for the last 6 months.

History of psychiatric illness such as severe anxiety, severe depression, Schizophrenia or bipolar disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants practice Shambhavi Mahamudra Kriya meditation daily for 6 months

6 months

Baseline and 6-month assessments

Follow-up

Participants are monitored for changes in brain health and cognitive function

4 weeks

Treatment Details

Interventions

• Shambhavi Madamudra Kriya

Trial Overview The trial tests if Shambhavi Mahamudra Kriya—a 21-minute meditation practice—can improve brain health and cognitive function. Participants will regularly perform this meditation to see its effects on their mental and physiological state.

Participant Groups

Group I: Wellness and Meditation-Based Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Findings from Research

Long-term practice of Sahaja Yoga Meditation is linked to increased grey matter volume in the brain, particularly in areas associated with attention, self-control, and compassion, based on a study of 23 experienced meditators compared to 23 non-meditators.

Meditators showed larger grey matter volume in several right hemispheric regions, indicating that regular meditation may lead to structural brain changes that enhance cognitive functions related to emotional regulation and awareness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Grey Matter Associated with Long-Term Sahaja Yoga Meditation: A Voxel-Based Morphometry Study. Hernández, SE., Suero, J., Barros, A., et al.[2023]

Long-term meditation practice in individuals with mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) resulted in significant increases in cortical thickness and gray matter volume in key brain areas associated with executive function and memory, suggesting potential neuroprotective effects.

The study, which involved detailed clinical assessments and high-resolution MRI scans over 6 months, found that meditators showed greater improvements in brain structure compared to non-meditators, particularly in regions vulnerable to neurodegeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Meditation on Structural Changes of the Brain in Patients With Mild Cognitive Impairment or Alzheimer's Disease Dementia. Dwivedi, M., Dubey, N., Pansari, AJ., et al.[2021]

Both dhāraṇā (meditative focusing) and ekāgratā (focusing without meditation) significantly improved attention scores in a group of 60 healthy male volunteers aged 17 to 38, indicating that both practices can enhance attention.

However, dhāraṇā led to better performance in the digit symbol substitution test, suggesting it may be more effective for improving incidental learning and accuracy compared to ekāgratā.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance in attentional tasks following meditative focusing and focusing without meditation. Raghavendra, BR., Telles, S.[2022]

Kirtan Kriya (KK) meditation, which takes only 12 minutes a day, has been shown to improve memory and cognitive function in individuals at risk for Alzheimer's disease, including those with mild cognitive impairment and stressed caregivers.

KK meditation not only enhances cognitive abilities but also positively affects overall well-being by improving sleep, reducing anxiety and depression, and promoting immune function, making it a valuable tool in Alzheimer's disease prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress, Meditation, and Alzheimer's Disease Prevention: Where The Evidence Stands. Khalsa, DS.[2023]

In a study involving 11 healthy individuals, chanting meditation was linked to increased blood flow in the right temporal lobe and posterior cingulate gyrus, suggesting enhanced brain activity in these areas during meditation.

The findings align with previous research on meditation and support anecdotal reports of positive effects, indicating that this practice may lead to beneficial changes in brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral blood flow changes during chanting meditation. Khalsa, DS., Amen, D., Hanks, C., et al.[2022]

Meditation is associated with measurable changes in brain activity, including increased theta and alpha waves, which relate to the practitioner's skill level, indicating its potential for enhancing cognitive functions.

Neuroimaging studies show that meditation increases blood flow in specific brain regions, particularly the anterior cingulate cortex and dorsolateral prefrontal areas, suggesting its effectiveness in improving attention and emotional regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation states and traits: EEG, ERP, and neuroimaging studies. Cahn, BR., Polich, J.[2023]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

A systematic review of 83 studies involving 6703 participants found that 8.3% experienced adverse events (AEs) related to meditation, with higher prevalence in observational studies (33.2%) compared to experimental studies (3.7%).

The most common adverse events included anxiety (33%), depression (27%), and cognitive anomalies (25%), indicating that meditation can lead to negative effects, even in individuals without prior mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in meditation practices and meditation-based therapies: a systematic review. Farias, M., Maraldi, E., Wallenkampf, KC., et al.[2021]

After 30 days of practicing Santhi Kriya, participants showed a significant reduction in body weight and an increase in brain alpha activity, indicating enhanced calmness.

The practice also led to a notable increase in oral temperature and a decrease in respiratory rate, suggesting potential benefits for overall physiological relaxation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Santhi Kriya on certain psychophysiological parameters: a preliminary study. Satyanarayana, M., Rajeswari, KR., Rani, NJ., et al.[2022]

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., et al.[2022]

The study aimed to compare brain activity patterns, specifically resting EEG, BAER, and P300 responses, between trained practitioners of Sudarshan Kriya (SK) and regular practitioners, as well as a control group.

This research could provide insights into how Sudarshan Kriya may influence brain function and auditory processing, potentially highlighting its benefits for mental health and cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiologic evaluation of Sudarshan Kriya: an EEG, BAER, P300 study. Bhatia, M., Kumar, A., Kumar, N., et al.[2019]

The Meditation on Twin Hearts (MTH) led to immediate cognitive improvements in nonmeditators, as evidenced by increased P300 amplitude, indicating enhanced cognitive processing after the meditation.

Experienced meditators showed shorter peak latency in brain responses compared to nonmeditators, suggesting that long-term practice of MTH may lead to more stable and efficient cognitive processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Meditation on Twin Hearts on P300 Values: A Repeated Measures Comparison of Nonmeditators and the Experienced. Tarrant, JM., Raines, N., Blinne, WR.[2023]

Kapalbhati pranayam significantly affects heart rate variability (HRV), indicating a shift towards sympathetic activation and parasympathetic withdrawal during and after practice, which suggests an energizing effect.

While there were notable changes in HRV, brain wave activity showed only insignificant changes, except for an increase in gamma wave activation post-pranayama, which may indicate improved control of the brain's default mode network.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of immediate neurological and autonomic changes during kapalbhati pranayama in yoga practitioners. Malhotra, V., Javed, D., Wakode, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Increased Grey Matter Associated with Long-Term Sahaja Yoga Meditation: A Voxel-Based Morphometry Study. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Meditation on Structural Changes of the Brain in Patients With Mild Cognitive Impairment or Alzheimer's Disease Dementia. [2021]

3. India pubmed.ncbi.nlm.nih.gov

Performance in attentional tasks following meditative focusing and focusing without meditation. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Stress, Meditation, and Alzheimer's Disease Prevention: Where The Evidence Stands. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Cerebral blood flow changes during chanting meditation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Meditation states and traits: EEG, ERP, and neuroimaging studies. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events in meditation practices and meditation-based therapies: a systematic review. [2021]

9. India pubmed.ncbi.nlm.nih.gov

Effect of Santhi Kriya on certain psychophysiological parameters: a preliminary study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Electrophysiologic evaluation of Sudarshan Kriya: an EEG, BAER, P300 study. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

The Effects of Meditation on Twin Hearts on P300 Values: A Repeated Measures Comparison of Nonmeditators and the Experienced. [2023]

13. India pubmed.ncbi.nlm.nih.gov

Study of immediate neurological and autonomic changes during kapalbhati pranayama in yoga practitioners. [2022]