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Completed

NCT Number: NCT05020301

Investigation of Functional Brain Network in Altered Meditation State With Multimodal Neuroimaging

The purpose of this study is to investigate functional brain network in altered meditation state with multimodal neuroimaging.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Biomedical Engineering, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200030, China

About this study

  • Recruiting participants by approaching mindfulness training, poster, and websites.
  • Completing Questionnaires, Tests, and other materials for experiments.
  • Examining Functional Brain Network of Internal and External Meditation of practitioners with a meditation using multimodal neuroimaging.
  • Collecting and evaluating data about the connection of internal and external meditation with multimodal neuroimaging and identifying the function related to meditation state.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A sufficient level of education to understand study procedure and be able to communicate with site personnel.
  • 18-60 years old.
  • Interested in meditation.
  • No metal or electronic implants in the body; no prosthesis (metal braces, dentures, etc.); no claustrophobia; no tattoos, piercings, etc.; no makeup on the day of the experiment.
  • Right-handed.

Exclusion criteria

  • The participant has a contraindication to MRI examination, such as claustrophobia.
  • The participant is physically unfit for MRI, such as having a metal implant.
  • The participant has a history of neurological or psychiatric disorders, or is taking any chronic medications that may interfere with the experiment.

Treatment and study plan

external meditation guided audio

Device

Examining DMN connectivity and CSF flow in external meditation state by External Meditation Instruction Audio.

internal meditation guided audio

Device

Examining DMN connectivity and CSF flow in external meditation state by Internal Meditation Instruction Audio.

Primary outcomes

  1. Five Facet Mindfulness Questionnaire(FFMQ)

    Time frame: Week 1

    FFMQ is a validated, self-administered questionnaire that measures the tendency to act with mindfulness. Its 39 items are assessed on a Likert scale from 1 to 5 (i.e., "never or very rarely true" to "very often or always true"). The higher scores on the scale convey the higher tendency to act with mindfulness.

  2. CSF pulsation index

    Time frame: Week 1

    CSF pulsation index, calculated by the number of CSF pulsation per minute.

  3. Functional connectivity

    Time frame: Week 1

    Checking functional connectivity in major resting-state brain networks (such as DMN).

Secondary outcomes

  1. Mindfulness positive awareness examined by Mindful Attention Awareness Scale (MAAS)

    Time frame: Week 1

    MAAS is a validated, fifteen-item self-report measure on which the items are scored using a six-point rating scale (1 = almost always and 6 = almost never). The global score of the scale is obtained by calculating the mean score of each participant's responses, and higher scores on the scale convey the higher levels of dispositional mindfulness.

  2. The ability of self-compassion examined by Self-Compassion Scale(SCS) after 1-week practice of internal and external mindfulness

    Time frame: Week 1

    SCS is a validated, 26-item self-report measure on which the items are scored using a five-point Likert scale scored from 1 (almost never) to 5 (almost always). The higher total score on the scale indicates a higher level of self-compassion.

  3. Cognitive Flexibility Inventory(CFI)

    Time frame: Week 1

    CFI is a validated, self-reported measure of cognitive flexibility,which consists of 20 statements scored from 1 ( "definitely disagree") to 7( "definitely agree."). The scores for all items are pooled to generate a total score of 20 to 140. Higher total scores indicate the increasing level of cognitive flexibility.

  4. Perceived Stress Scale(PSS)

    Time frame: Week 1

    PSS is a validated, self-reported measure of psychological stress level. There are 10-items scored from 0 (never) to 4 (very often). The scores for all items are pooled to generate a total score in the range of 0 to 40. Higher total scores indicate the increasing level of psychological stress.

  5. The Chinese version of Freiburg Mindfulness Inventory(FMI-13)

    Time frame: Week 1

    FMI-13 is a validated, thirteen-item self-report measure on which the items are scored using a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). This short form was used for measuring mindfulness traits, and higher scores on the scale convey the higher levels of mindfulness trait.

Other outcomes

  1. Cognitive impairment quantitative assessment by Mini-Mental State Examination(MMSE)

    Time frame: Week 0

    MMSE is a validated, widely used screening tool for cognitive impairment quantitative assessment. It included 11 items. The scores for all items are pooled to generate a total score in the range of 0 to 30. A 27-point was proved to be an appropriate cutoff for cognitive impairment in a population with relatively high educational attainment.

  2. Intelligence assessment by Raven's Standard Progressive Matrices (SPM)

    Time frame: Week 0

    SPM is a validated intelligence assessment that consists of 60 non-colored diagrammatic puzzles with a missing part, which subjects should correctly choose one among six options. SPM scores were estimated as the total of participants' correct answers (0-60). Higher total scores indicate the increasing level of intelligence level.

  3. Brief Profile of Mood States(Brief-POMS)

    Time frame: Week 1

    The Brief-POMS is a validated,30-item measure, with items scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The scores for all items are pooled to generate a total score in the range of 0 to 120. A higher total score on the scale indicates a worse mood state.

  4. Mental flexibility assessment by Trail Making Test (TMT)

    Time frame: Week 1

    TMT is a validated mental flexibility assessment consisting of two parts (TMT-A and TMT-B ). The TMT-A consisted of a standardized page on which the numbers 1 to 25 were scattered within circles. The participants were asked to connect the numbers in order as quickly as possible. Similarly, the TMT-B consisted of a standardized page that included the numbers 1 to 13 and the letters A to L, which were randomly distributed. The participants were instructed to draw lines connecting numbers and letters (ascending and alphabetical) in alternating numbers and letters. A maximum time of 300 s was allowed before discontinuing the test. Direct scores of TMT were the time in seconds taken to complete each task (A and B). A Higher result indicates a worse cognitive outcome.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

  • School of Biomedical Engineering, Shanghai Jiao Tong University

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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