What side effects are associated with this type of intervention?

Meditation practices, including those similar to Shambhavi Mahamudra Kriya, generally have few side effects. However, some individuals may experience mild discomforts such as increased anxiety, emotional instability, or physical discomfort during prolonged sessions. Rarely, meditation can lead to dissociation or exacerbate underlying psychiatric conditions. It is important for individuals to practice under guidance, especially if they have pre-existing mental health issues.

What prior FDA approvals exist?

There are no FDA approvals specifically for meditation practices like Shambhavi Mahamudra Kriya. The FDA typically approves pharmacological treatments and medical devices rather than meditation or other non-pharmacological practices. However, there is growing research interest in the effects of meditation on brain health, cognitive function, and neuroplasticity, which may inform future therapeutic guidelines and integrative health practices.

What other types of research exist?

Promising alternatives to Shambhavi Mahamudra Kriya for influencing brain activity and neuroplasticity include deep repetitive transcranial magnetic stimulation (rTMS) targeting the bilateral dorsomedial prefrontal cortex, which has shown reductions in social relating impairment and anxiety in autism spectrum disorder, and acupuncture therapy, which has demonstrated modulation of corticomotoneuronal excitability and interhemispheric competition in healthy subjects.

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Meditation for Brain Health (BLISS Trial)

N/A

Recruiting

Led By Balachundar Subramaniam, MD, MPH

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline and 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Meditation practices like Shambhavi Mahamudra Kriya typically have minimal side effects; however, some individuals may experience discomfort during sitting, mild headaches or fatigue post-meditation. Rarely it might trigger emotional distress if underlying psychological conditions are present.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Change in Brain Connectivity after 6 Months of Daily Meditation Practice

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

Brain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Wellness and Meditation-Based InterventionExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Meditation practices like Shambhavi Mahamudra Kriya influence brain activity and neuroplasticity by promoting relaxation, reducing stress, and enhancing cognitive function. These practices typically involve focused attention, deep breathing, and mindfulness, which can lead to changes in brain regions associated with attention, emotion regulation, and self-awareness. The increased neuroplasticity helps in forming new neural connections, improving mental flexibility, and resilience. For patients, these mechanisms are crucial as they can lead to better management of stress, anxiety, and overall mental well-being, contributing to improved quality of life.

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