Investigation of Functional Brain Network in Altered Meditation State With Multimodal Neuroimaging
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to investigate functional brain network in altered meditation state with multimodal neuroimaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2020
CompletedFirst Submitted
Initial submission to the registry
July 14, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJuly 23, 2026
June 1, 2021
3.3 years
July 14, 2021
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Five Facet Mindfulness Questionnaire(FFMQ)
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.
Week 1
CSF pulsation index
CSF pulsation index, calculated by the number of CSF pulsation per minute.
Week 1
Functional connectivity
Checking functional connectivity in major resting-state brain networks (such as DMN).
Week 1
Secondary Outcomes (5)
Mindfulness positive awareness examined by Mindful Attention Awareness Scale (MAAS)
Week 1
The ability of self-compassion examined by Self-Compassion Scale(SCS) after 1-week practice of internal and external mindfulness
Week 1
Cognitive Flexibility Inventory(CFI)
Week 1
Perceived Stress Scale(PSS)
Week 1
The Chinese version of Freiburg Mindfulness Inventory(FMI-13)
Week 1
Other Outcomes (4)
Cognitive impairment quantitative assessment by Mini-Mental State Examination(MMSE)
Week 0
Intelligence assessment by Raven's Standard Progressive Matrices (SPM)
Week 0
Brief Profile of Mood States(Brief-POMS)
Week 1
- +1 more other outcomes
Study Arms (2)
Novice meditators
EXPERIMENTALParticipants who have no meditation practice in the previous year and less than 20 entire lifetime hours' meditation.
Experienced meditators
EXPERIMENTALParticipants with more than two years of mindfulness practice
Interventions
Examining DMN connectivity and CSF flow in external meditation state by External Meditation Instruction Audio.
Examining DMN connectivity and CSF flow in external meditation state by Internal Meditation Instruction Audio.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Biomedical Engineering, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200030, China
Study Officials
- STUDY CHAIR
Qing Fan
Shanghai Mental Health Center
- STUDY CHAIR
Jie Luo
School of Biomedical Engineering, Shanghai Jiao Tong University
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, 2023
Study Completion
December 30, 2023
Last Updated
July 23, 2026
Record last verified: 2021-06