MEDITATION: Brain and Mindfulness

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03117478
Collaborator
(none)
169
1
4
42.9
3.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Magneto-encephalography (MEG)
  • Other: Electro-encephalography (EEG)
  • Other: Functional Magnetic Resonance Imaging (fMRI)
  • Other: Anatomical Magnetic Resonance Imaging (aMRI)
  • Other: Meditation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
169 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Impact of Meditation Practice on Attention and Emotion Regulation :Studies on Neural Correlation in Brain Imagery and Biomarkers of Stress and Inflammation
Actual Study Start Date :
Mar 19, 2016
Actual Primary Completion Date :
Oct 16, 2019
Actual Study Completion Date :
Oct 16, 2019

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Anatomical MRI scan [Day 1]

    Brain structure

  2. Functional MRI scan [Day1]

    Brain activation: Haemodynamic response - BOLD signal.

  3. EEG [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

Secondary Outcome Measures

  1. Behavioral measure : Accuracy of the performed task actions [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

  2. Psychophysics: Pain threshold [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.

  3. Psychophysiology : Respiration [Day 1]

    Respiration rate: breaths/minute

  4. Subjective experience of the participant [Day 1]

  5. Studies biomarkers of inflammation [Day 1]

    area of the inflamed site in mm^2, obtained by automatic image processing of a photography

  6. Behavioral measure : Speed of the performed task actions [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.

  7. Psychophysiology : Heart [Day 1]

    Heart Rate: pulses/minute

  8. Psychophysiology : Heart rate variability [Day 1]

    Heart rate variability (HRV): Using an electrocardiogram, the variation in the beat-to-beat interval; measured in ms.

  9. Psychophysiology : Muscles [Day 1]

    Electromyography (EMG): Recording the electrical activity produced by muscles; measured in mV.

  10. Psychophysiology : Eyes [Day 1]

    Eye gaze position: relative to center of the screen, in imm

  11. Psychophysiology : Pupillar response [Day 1]

    Pupillar response: pupil diameter, in mm.

  12. Electrogastrogram [Day 1]

    Recording the electrical signals that travel through the stomach muscles and control the muscles' contractions (waves/minute)

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Le Vinatier Bron France 69500

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sandrine SONIE, MD, Le Vinatier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03117478
Other Study ID Numbers:
  • 69HCL16_0678
First Posted:
Apr 18, 2017
Last Update Posted:
Jun 18, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 18, 2021