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

NCT05020301 | Unknown

• 1 other identifier: B20200361
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meditation; Mindfulness

Keywords

mindfulness; functional brain network; neuroimaging; meditation

Outcome Measures

Primary Outcomes (9)

• Mindfulness positive awareness examined by Mindful Attention Awareness Scale (MAAS), Five Facet Mindfulness Questionnaire(FFMQ), The Chinese version of Freiburg Mindfulness Inventory(FMI-13) after the 1-week practice of internal and external mindfulness

  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. 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. 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.

  Week 2

• The mental states examined by Brief Profile of Mood States(Brief-POMS), Perceived Stress Scale(PSS) after the 1-week practice of internal and external mindfulness

  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. 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.

  Week 2

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

  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.

  Week 2

• The cognitive flexibility examined by Cognitive Flexibility Inventory(CFI) after the 1-week practice of internal and external mindfulness

  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.

  Week 2

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

  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.

  Week 2

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

  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.

  Week 2

• Mental flexibility assessment by Trail Making Test (TMT)

  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.

  Week 2

• CSF pulsation index

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

  Week 2

• Functional connectivity

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

  Week 2

Study Arms (3)

Control group

EXPERIMENTAL

Participants who have never practiced mindfulness

Device: external meditation guided audio; Device: internal meditation guided audio

Beginner Practitioner

EXPERIMENTAL

Participants with less than two years of mindfulness practice

Device: external meditation guided audio; Device: internal meditation guided audio

Advanced Practitioner

EXPERIMENTAL

Participants with more than two years of mindfulness practice

Device: external meditation guided audio; Device: internal meditation guided audio

Interventions

external meditation guided audio DEVICE

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

Advanced Practitioner; Beginner Practitioner; Control group

internal meditation guided audio DEVICE

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

Advanced Practitioner; Beginner Practitioner; Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A sufficient level of education to understand study procedure and be able to communicate with site personnel.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• School of Biomedical Engineering, Shanghai Jiao Tong University: collaborator

Study Sites (1)

School of Biomedical Engineering, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Study Officials

• Qing Fan

  Shanghai Mental Health Center

  STUDY CHAIR

• Jie Luo

  School of Biomedical Engineering, Shanghai Jiao Tong University

  STUDY CHAIR

Central Study Contacts

Yue Zheng

CONTACT

8602133612084; zhengyue@ecust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 25, 2021
• Study Start: September 20, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-06

Locations

CN (1)