NCT05020301

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 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

September 20, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 23, 2026

Status Verified

June 1, 2021

Enrollment Period

3.3 years

First QC Date

July 14, 2021

Last Update Submit

July 21, 2026

Conditions

Keywords

mindfulnessfunctional brain networkneuroimagingmeditation

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

EXPERIMENTAL

Participants who have no meditation practice in the previous year and less than 20 entire lifetime hours' meditation.

Device: external meditation guided audioDevice: internal meditation guided audio

Experienced meditators

EXPERIMENTAL

Participants with more than two years of mindfulness practice

Device: external meditation guided audioDevice: internal meditation guided audio

Interventions

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

Experienced meditatorsNovice meditators

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

Experienced meditatorsNovice meditators

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

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

Location

Study Officials

  • Qing Fan

    Shanghai Mental Health Center

    STUDY CHAIR
  • Jie Luo

    School of Biomedical Engineering, Shanghai Jiao Tong University

    STUDY CHAIR

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

Locations