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

Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020301
• Other study ID #: B20200361
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: June 2021
• Source: Shanghai Mental Health Center
• Contact: Yue Zheng
• Phone: 8602133612084
• Email: zhengyue[@]ecust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

1. Recruiting participants by approaching mindfulness training, poster, and websites.

2. Completing Questionnaires, Tests, and other materials for experiments.

3. Examining Functional Brain Network of Internal and External Meditation of practitioners with a meditation using multimodal neuroimaging.

4. Collecting and evaluating data about the connection of internal and external meditation with multimodal neuroimaging and identifying the function related to meditation state.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meditation
• Mindfulness

Intervention

Device:
• external meditation guided audio
Examining DMN connectivity and CSF flow in external meditation state by External Meditation Instruction Audio.
• internal meditation guided audio
Examining DMN connectivity and CSF flow in external meditation state by Internal Meditation Instruction Audio.

Locations

Country	Name	City	State
China	School of Biomedical Engineering, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	School of Biomedical Engineering, Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	CSF pulsation index	CSF pulsation index, calculated by the number of CSF pulsation per minute.	Week 2
Primary	Functional connectivity	Checking functional connectivity in major resting-state brain networks (such as DMN).	Week 2