Brain and Mindfulness (MEDITATION)

September 15, 2025 updated by: Hospices Civils de Lyon

The Impact of Meditation Practice on Attention and Emotion Regulation :Studies on Neural Correlation in Brain Imagery and Biomarkers of Stress and Inflammation

The main aim of this project is to explore the neuro-anatomical and -physiological correlates of meditation on attention and emotion-regulation. By investigating this, our scientific goal is to more generally identify the mechanisms and biomarkers of health and mental well-being. Therefore, the investigators use non-invasive imaging like Magneto-EncephaloGraphy (MEG), ElectroEncephaloGraphy (EEG), functional and anatomic Magnetic Resonance Imaging (MRI; including Diffusion tensor - DTI). These brain measures will then be linked to behavioral measurements. Experimental methods (i.e., simple computer tasks) will be used to measure attention, conscious perception and regulation of pain and emotion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Le Vinatier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age : 25-70
  • Being affiliated to a social security system.
  • Motivated to participate in this study.

Exclusion Criteria:

  • Medication acting on the central nervous system
  • Opioids, Antidepressive Agents.
  • Actual or previous neurological or psychiatric illnesses
  • Chronic pain or any other medical condition which is related to pain or an increased sensitivity to pain.
  • Not having a personal or family history of epilepsy
  • Alcohol or drugs consumption 2 days before or during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 1. Participants without meditation experience
Novices. Note that there is no meditation intervention in this study but that the two groups differ in their lifetime meditation experience.
Other: Magneto-encephalography (MEG)
Magneto-encephalography
Other: Electro-encephalography (EEG)
Electro-encephalography
Other: Functional Magnetic Resonance Imaging (fMRI)
Functional Magnetic Resonance Imaging
Other: Anatomical Magnetic Resonance Imaging (aMRI)
Anatomical Magnetic Resonance Imaging
Other: Meditation
Meditation
Other: 2. Participant with a significant meditation experience
Experts : > 5000 hours of practice during their life. Note that there is no meditation intervention in this study but that the two groups differ in their lifetime meditation experience.
Other: Magneto-encephalography (MEG)
Magneto-encephalography
Other: Electro-encephalography (EEG)
Electro-encephalography
Other: Functional Magnetic Resonance Imaging (fMRI)
Functional Magnetic Resonance Imaging
Other: Anatomical Magnetic Resonance Imaging (aMRI)
Anatomical Magnetic Resonance Imaging
Other: Meditation
Meditation
Other: 3. Participants without meditation experience
Novices. There is no meditation intervention during the study but the investigators investigate the effects of meditation by comparing 2 groups who differ in their life time meditation experience (i.e., novices vs. experts).
Other: Magneto-encephalography (MEG)
Magneto-encephalography
Other: Electro-encephalography (EEG)
Electro-encephalography
Other: Functional Magnetic Resonance Imaging (fMRI)
Functional Magnetic Resonance Imaging
Other: Anatomical Magnetic Resonance Imaging (aMRI)
Anatomical Magnetic Resonance Imaging
Other: 4. Participant with a significant meditation experience
Experts : > 5000 hours of practice during their life. There is no meditation intervention during the study but the investigators investigate the effects of meditation by comparing 2 groups who differ in their life time meditation experience (i.e., novices vs. experts).
Other: Magneto-encephalography (MEG)
Magneto-encephalography
Other: Electro-encephalography (EEG)
Electro-encephalography
Other: Functional Magnetic Resonance Imaging (fMRI)
Functional Magnetic Resonance Imaging
Other: Anatomical Magnetic Resonance Imaging (aMRI)
Anatomical Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anatomical MRI scan
Time Frame: Day 1
Brain structure
Day 1
Functional MRI scan
Time Frame: Day1
Brain activation: Haemodynamic response - BOLD signal.
Day1
EEG
Time Frame: Day 1
Event-related potential fields : amplitude in fT and latency in ms. Oscillations : power spectral density and time-frequency oscillations in fT^2/Hz
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavioral measure : Accuracy of the performed task actions
Time Frame: Day 1
Participants will perform behavioral computer tasks in which accuracy and speed is important. Performance behavior will be measured in this task: Accuracy of the performed task actions: number of errors and hits
Day 1
Psychophysics: Pain threshold
Time Frame: Day 1
Pain threshold: The threshold of pain or pain threshold is the point along a curve of increasing perception of a stimulus at which pain begins to be felt. The temperature in degrees Celcius at which heat becomes painful for a recipient.
Day 1
Psychophysiology : Respiration
Time Frame: Day 1
Respiration rate: breaths/minute
Day 1
Subjective experience of the participant
Time Frame: Day 1
Day 1
Studies biomarkers of inflammation
Time Frame: Day 1
area of the inflamed site in mm^2, obtained by automatic image processing of a photography
Day 1
Behavioral measure : Speed of the performed task actions
Time Frame: Day 1
Participants will perform behavioral computer tasks in which accuracy and speed is important. Performance behavior will be measured in this task: Speed of the performed task actions: in ms.
Day 1
Psychophysiology : Heart
Time Frame: Day 1
Heart Rate: pulses/minute
Day 1
Psychophysiology : Heart rate variability
Time Frame: Day 1
Heart rate variability (HRV): Using an electrocardiogram, the variation in the beat-to-beat interval; measured in ms.
Day 1
Psychophysiology : Muscles
Time Frame: Day 1
Electromyography (EMG): Recording the electrical activity produced by muscles; measured in mV.
Day 1
Psychophysiology : Eyes
Time Frame: Day 1
Eye gaze position: relative to center of the screen, in imm
Day 1
Psychophysiology : Pupillar response
Time Frame: Day 1
Pupillar response: pupil diameter, in mm.
Day 1
Electrogastrogram
Time Frame: Day 1
Recording the electrical signals that travel through the stomach muscles and control the muscles' contractions (waves/minute)
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandrine SONIE, MD, Le Vinatier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL16_0678

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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