- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05020301
Investigation of Functional Brain Network in Altered Meditation State With Multimodal Neuroimaging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yue Zheng
- Phone Number: 8602133612084
- Email: zhengyue@ecust.edu.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200030
- Recruiting
- School of Biomedical Engineering, Shanghai Jiao Tong University
-
Contact:
- Yue Zheng, M.S.
- Phone Number: 8602133612084
- Email: zhengyue@ecust.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control group
Participants who have never practiced mindfulness
|
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.
|
Experimental: Beginner Practitioner
Participants with less than two years of mindfulness practice
|
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.
|
Experimental: Advanced Practitioner
Participants with more than two years of mindfulness practice
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Week 2
|
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
Time Frame: Week 2
|
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)
Time Frame: Week 2
|
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
Time Frame: Week 2
|
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
Time Frame: Week 2
|
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)
Time Frame: Week 2
|
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)
Time Frame: Week 2
|
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
Time Frame: Week 2
|
CSF pulsation index, calculated by the number of CSF pulsation per minute.
|
Week 2
|
Functional connectivity
Time Frame: Week 2
|
Checking functional connectivity in major resting-state brain networks (such as DMN).
|
Week 2
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Qing Fan, Shanghai Mental Health Center
- Study Chair: Jie Luo, School of Biomedical Engineering, Shanghai Jiao Tong University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- B20200361
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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