NCT07005830

Brief Summary

The goal of this clinical trial is to examine the impact of a specific guided meditation (Twin Hearts Meditation; THM) on cognitive functioning and EEG dynamics in experienced and inexperienced meditators. The main questions it aims to answer are:

  • Will the experienced meditators outperform inexperienced meditators on the attention control tasks (Flanker, Trails A \& B) at baseline (pre-meditation)?
  • Will both groups show improvements in performance after meditation associated with mood and physiological state changes?
  • Will the experienced meditators show an overall mood profile of higher positive mood states and less negative mood states (Brunel Mood Scale subscale difference) at baseline (pre-meditation)?
  • Will both groups show mood state improvements after meditation?
  • Will the experienced meditators show differences in electrophysiological characteristics compared to inexperienced meditators?
  • Will inexperienced meditators exhibit shifts from their baseline resting-state EEG towards being more similar to the EEG characteristics of experienced meditators at baseline?
  • Will experienced meditators demonstrate differences in P300 latencies and amplitudes on the auditory oddball paradigm. Participants will:
  • Take a series of pre-meditation surveys.
  • Complete pre-meditation P300 auditory oddball task.
  • Complete pre-meditation cognitive behavioral task set.
  • Continuous 19-channel EEG recording before and after pre-recorded guided THM.
  • Take a series of post-meditation surveys.
  • Complete post-session P300 auditory oddball task.
  • Complete post-session cognitive behavioral task set.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

April 17, 2025

Last Update Submit

May 27, 2025

Conditions

Keywords

meditationElectroencephalographyemotional regulationTrail Making TestCognitive NeurosciencemoodP300

Outcome Measures

Primary Outcomes (9)

  • Mood Differences and Changes in Experienced vs. Inexperienced Meditators

    This study examines both baseline mood differences \& post-meditation mood changes between experienced \& inexperienced meditators using Brunel Mood Scale, a 32-item self-report measure designed to assess current mood states. It consists of 8 unipolar mood dimensions: anger, tension, depression, vigor, fatigue, confusion, happiness \& calmness. Participants respond to prompt "How do you feel right now?" by rating each mood descriptor on a 5-point Likert scale (0=not at all to 4=extremely), indicating intensity of their momentary emotional experience. As well as producing subscale scores, an overall Total Mood Disturbance (TMD) score can be calculated by summing the scores for Tension, Depression, Anger, Fatigue \& Confusion and then subtracting Vigor score. Higher TMD scores indicate greater overall mood disturbance, reflecting higher levels of negative emotions inversely correlated with lower positive affect. Conversely, lower scores suggest better mood balance \& emotional well-being.

    the 25 minutes of the pre-recorded meditation

  • Cognitive Performance in Experienced vs. Inexperienced Meditators: Trail Making A Outcomes

    This study examines cognitive changes using the Trail Making Test-A (TMT-A), which assesses processing speed (TMT-A) by measuring the time taken to connect a sequence of numbers. Performance metrics included the number of errors per trial and time to completion, with the latter serving as the primary performance indicator.

    5 minutes

  • Cognitive Performance in Experienced vs. Inexperienced Meditators: Trail Making B Outcomes

    This study examines cognitive changes using the Trail Making Test-B (TMT-B) which assesses cognitive flexibility/executive function (TMT-B) by measuring the time taken to connect a sequence of alternating numbers and letters. Performance metrics included the number of errors per trial and time to completion, with the latter serving as the primary performance indicator.

    5 minutes

  • Cognitive Performance in Experienced vs. Inexperienced Meditators: Flanker Test Selective Attention Outcomes

    This study examines cognitive changes using the Flanker Test. Participants are required to quickly identify a central target stimulus while ignoring distracting stimuli on either side, measuring their ability to maintain focus despite interference. In this study, the Flanker Task was administered using the WAVi software platform, with a total test duration of approximately five minutes. Performance metrics include the number of total errors.

    5 minutes

  • Cognitive Performance in Experienced vs. Inexperienced Meditators: Flanker Test Inhibitory Control Outcomes

    This study examines baseline cognitive differences and post-meditation cognitive changes between experienced and inexperienced meditators using the Flanker Test. The Flanker test evaluates inhibitory control defined as the ability to suppress the influence of the flankers and respond correctly to the control. Participants are required to quickly identify a central target stimulus while ignoring distracting stimuli on either side, measuring their ability to maintain focus despite interference. In this study, the Flanker Task was administered using the WAVi software platform, with a total test duration of approximately five minutes. Performance metrics include the error rates for congruent and incongruent flanker trials.

    the 25 minutes of the pre-recorded meditation

  • P300 Event-Related Potential in Experienced vs. Inexperienced Meditators: Amplitude Outcomes

    Study examines baseline neurocognitive differences \& post-meditation changes in P300 event-related potentials (ERPs) between experienced \& inexperienced meditators, using auditory oddball paradigm to assess amount of cognitive resources used. Task consisted of 200 common tones \& 40 randomly presented rare (higher-pitched) tones, at 1 Hz. Participants pressed mouse button upon hearing rare tone. Before beginning, participants had opportunities to practice task to ensure comprehension \& accuracy. Measurements acquired \& used for analyses included p300 amplitude. Higher amplitude indicates more attention was allocated to the stimulus and suggests stronger engagement, better stimulus discrimination, and/or higher motivation.

    the 25 minutes of the pre-recorded meditation

  • P300 Event-Related Potential in Experienced vs. Inexperienced Meditators: Latency Outcomes

    Study examines baseline neurocognitive differences \& post-meditation changes in P300 event-related potentials (ERPs) between experienced \& inexperienced meditators, using auditory oddball paradigm to assess cognitive efficiency. Task consisted of 200 common tones \& 40 randomly presented rare (higher-pitched) tones, at 1 Hz. Participants pressed mouse button upon hearing rare tone. Before beginning, participants had opportunities to practice task to ensure comprehension \& accuracy. Measurements acquired \& used for analyses included p300 latency. Latency refers to the time delay, in milliseconds, between presentation of a target stimulus and peak of the P300 wave. It reflects the speed of stimulus evaluation \& decision-making processes. Shorter P300 latencies indicate faster cognitive processing, whereas longer latencies are associated with delayed neural responses, often observed in people with cognitive impairments or attentional deficits.

    the 25 minutes of the pre-recorded meditation

  • Alpha Peak Frequency in Experienced vs. Inexperienced Meditators

    This study examines baseline neurophysiological differences and post-meditation changes alpha peak frequency (APF) between experienced and inexperienced meditators. Alpha Peak Frequency (APF): Reflects the speed of intrinsic neural oscillations, with higher APF linked to greater cognitive efficiency, attentional stability, and mental flexibility.

    the 25 minutes of the pre-recorded meditation

  • Frontal Asymmetry in Experienced vs. Inexperienced Meditators

    This study examines baseline neurophysiological differences and post-meditation changes in EEG frontal asymmetry, between experienced and inexperienced meditators. These measures provide insights into cognitive flexibility, attentional control, emotional regulation, and meditation-induced neural adaptations. Frontal Alpha Asymmetry (FAA): Measures relative left vs. right frontal alpha power, where greater rightward asymmetry is associated with approach motivation and positive affect, while leftward asymmetry is linked to withdrawal tendencies and negative mood.

    the 25 minutes of the pre-recorded meditation

Study Arms (1)

Impact of Meditation on Mood, Cognitive Function, & EEG Dynamics by Meditation Experience Level

EXPERIMENTAL

Twin Hearts Meditation (THM) is a 21-minute guided meditation practice developed by Master Choa Kok Sui as part of Pranic Healing \& Arhatic Yoga (Sui, 2005). It is designed to promote spiritual development, emotional balance, and cognitive well-being by activating and harmonizing the heart chakra (emotional love) and the crown chakra (divine love and higher consciousness). The meditation is based on the principle that blessing the Earth with loving-kindness leads to inner transformation and heightened awareness. The meditation itself is divided into several sections that include (in order of appearance), an invocation for divine blessings, an abbreviated prayer of St. Francis of Assisi, activation of the heart and crown chakras, blessing the Earth with lovingkindness, chanting the mantra "OM," silent meditation, and a closing.

Behavioral: Twin Hearts Meditation

Interventions

Twin Hearts Meditation (THM) is a 21-minute guided meditation practice developed by Master Choa Kok Sui as part of Pranic Healing \& Arhatic Yoga (Sui, 2005).

Impact of Meditation on Mood, Cognitive Function, & EEG Dynamics by Meditation Experience Level

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • English speaking
  • capable of providing consent.

You may not qualify if:

  • \- history of traumatic brain injury or serious mental health concerns (schizophrenia, bipolar disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NeuroMeditation Institute

Eugene, Oregon, 97401, United States

Location

Related Publications (17)

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    PMID: 20363650BACKGROUND
  • Travis F, Haaga DA, Hagelin J, Tanner M, Arenander A, Nidich S, Gaylord-King C, Grosswald S, Rainforth M, Schneider RH. A self-referential default brain state: patterns of coherence, power, and eLORETA sources during eyes-closed rest and Transcendental Meditation practice. Cogn Process. 2010 Feb;11(1):21-30. doi: 10.1007/s10339-009-0343-2. Epub 2009 Oct 28.

    PMID: 19862565BACKGROUND
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    PMID: 4844914BACKGROUND
  • Tarrant JM, Raines N, Blinne WR. The Effects of Meditation on Twin Hearts on P300 Values: A Repeated Measures Comparison of Nonmeditators and the Experienced. Integr Med (Encinitas). 2019 Apr;18(2):36-41.

    PMID: 31341443BACKGROUND
  • Lan MF, Lane AM, Roy J, Hanin NA. Validity of the Brunel Mood Scale for use With Malaysian Athletes. J Sports Sci Med. 2012 Mar 1;11(1):131-5. eCollection 2012.

    PMID: 24149128BACKGROUND
  • Singhal, T., Manjhi, D., & Kumar, S. (2015). Neuroplastic changes following Twin Hearts Meditation: A functional MRI study. Indian Journal of Psychiatry, 57(3), 281-286.

    BACKGROUND
  • Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

    PMID: 29034226BACKGROUND
  • Rolffs JL, Rogge RD, Wilson KG. Disentangling Components of Flexibility via the Hexaflex Model: Development and Validation of the Multidimensional Psychological Flexibility Inventory (MPFI). Assessment. 2018 Jun;25(4):458-482. doi: 10.1177/1073191116645905. Epub 2016 May 5.

    PMID: 27152011BACKGROUND
  • Mrazek MD, Franklin MS, Phillips DT, Baird B, Schooler JW. Mindfulness training improves working memory capacity and GRE performance while reducing mind wandering. Psychol Sci. 2013 May;24(5):776-81. doi: 10.1177/0956797612459659. Epub 2013 Mar 28.

    PMID: 23538911BACKGROUND
  • Leiberg S, Klimecki O, Singer T. Short-term compassion training increases prosocial behavior in a newly developed prosocial game. PLoS One. 2011 Mar 9;6(3):e17798. doi: 10.1371/journal.pone.0017798.

    PMID: 21408020BACKGROUND
  • Lehrer P, Kaur K, Sharma A, Shah K, Huseby R, Bhavsar J, Sgobba P, Zhang Y. Heart Rate Variability Biofeedback Improves Emotional and Physical Health and Performance: A Systematic Review and Meta Analysis. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):109-129. doi: 10.1007/s10484-020-09466-z.

    PMID: 32385728BACKGROUND
  • Hutcherson CA, Seppala EM, Gross JJ. Loving-kindness meditation increases social connectedness. Emotion. 2008 Oct;8(5):720-4. doi: 10.1037/a0013237.

    PMID: 18837623BACKGROUND
  • Holm, S. (1979). A Simple Sequentially Rejective Multiple Test Procedure. Scand. J. Stat. 6 (2), 65-70.

    BACKGROUND
  • Fox KC, Nijeboer S, Dixon ML, Floman JL, Ellamil M, Rumak SP, Sedlmeier P, Christoff K. Is meditation associated with altered brain structure? A systematic review and meta-analysis of morphometric neuroimaging in meditation practitioners. Neurosci Biobehav Rev. 2014 Jun;43:48-73. doi: 10.1016/j.neubiorev.2014.03.016. Epub 2014 Apr 3.

    PMID: 24705269BACKGROUND
  • Farb NA, Segal ZV, Mayberg H, Bean J, McKeon D, Fatima Z, Anderson AK. Attending to the present: mindfulness meditation reveals distinct neural modes of self-reference. Soc Cogn Affect Neurosci. 2007 Dec;2(4):313-22. doi: 10.1093/scan/nsm030.

    PMID: 18985137BACKGROUND
  • Chambers, R., Lo, B. C., & Allen, N. B. (2008). The impact of intensive mindfulness training on attentional control, cognitive style, and affect. Cognitive Therapy and Research, 32(3), 303-322.

    BACKGROUND
  • Alexander CN, Langer EJ, Newman RI, Chandler HM, Davies JL. Transcendental meditation, mindfulness, and longevity: an experimental study with the elderly. J Pers Soc Psychol. 1989 Dec;57(6):950-64. doi: 10.1037//0022-3514.57.6.950.

    PMID: 2693686BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Jeremy Viczko, PhD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Unblinded control group comparison (2x2 factorial design) with multi-modal measurements.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

June 5, 2025

Study Start

July 21, 2024

Primary Completion

November 7, 2024

Study Completion

November 7, 2024

Last Updated

June 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations