NCT03117478

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable healthy

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

March 19, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2019

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

3.6 years

First QC Date

February 8, 2017

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Anatomical MRI scan

    Brain structure

    Day 1

  • Functional MRI scan

    Brain activation: Haemodynamic response - BOLD signal.

    Day1

  • EEG

    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 Outcomes (12)

  • Behavioral measure : Accuracy of the performed task actions

    Day 1

  • Psychophysics: Pain threshold

    Day 1

  • Psychophysiology : Respiration

    Day 1

  • Subjective experience of the participant

    Day 1

  • Studies biomarkers of inflammation

    Day 1

  • +7 more secondary outcomes

Study Arms (4)

1. Participants without meditation experience

OTHER

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)Other: Electro-encephalography (EEG)Other: Functional Magnetic Resonance Imaging (fMRI)Other: Anatomical Magnetic Resonance Imaging (aMRI)Other: Meditation

2. Participant with a significant meditation experience

OTHER

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)Other: Electro-encephalography (EEG)Other: Functional Magnetic Resonance Imaging (fMRI)Other: Anatomical Magnetic Resonance Imaging (aMRI)Other: Meditation

3. Participants without meditation experience

OTHER

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)Other: Electro-encephalography (EEG)Other: Functional Magnetic Resonance Imaging (fMRI)Other: Anatomical Magnetic Resonance Imaging (aMRI)

4. Participant with a significant meditation experience

OTHER

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)Other: Electro-encephalography (EEG)Other: Functional Magnetic Resonance Imaging (fMRI)Other: Anatomical Magnetic Resonance Imaging (aMRI)

Interventions

Magneto-encephalography

1. Participants without meditation experience2. Participant with a significant meditation experience3. Participants without meditation experience4. Participant with a significant meditation experience

Electro-encephalography

1. Participants without meditation experience2. Participant with a significant meditation experience3. Participants without meditation experience4. Participant with a significant meditation experience

Functional Magnetic Resonance Imaging

1. Participants without meditation experience2. Participant with a significant meditation experience3. Participants without meditation experience4. Participant with a significant meditation experience

Anatomical Magnetic Resonance Imaging

1. Participants without meditation experience2. Participant with a significant meditation experience3. Participants without meditation experience4. Participant with a significant meditation experience

Meditation

1. Participants without meditation experience2. Participant with a significant meditation experience

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Vinatier

Bron, 69500, France

Location

Related Publications (10)

  • Zorn J, Abdoun O, Sonie S, Lutz A. Cognitive Defusion Is a Core Cognitive Mechanism for the Sensory-Affective Uncoupling of Pain During Mindfulness Meditation. Psychosom Med. 2021 Jul-Aug 01;83(6):566-578. doi: 10.1097/PSY.0000000000000938.

    PMID: 33790200BACKGROUND
  • Zorn J, Abdoun O, Bouet R, Lutz A. Mindfulness meditation is related to sensory-affective uncoupling of pain in trained novice and expert practitioners. Eur J Pain. 2020 Aug;24(7):1301-1313. doi: 10.1002/ejp.1576. Epub 2020 May 7.

    PMID: 32311185BACKGROUND
  • Poublan-Couzardot A, Lecaignard F, Fucci E, Davidson RJ, Mattout J, Lutz A, Abdoun O. Time-resolved dynamic computational modeling of human EEG recordings reveals gradients of generative mechanisms for the MMN response. PLoS Comput Biol. 2023 Dec 13;19(12):e1010557. doi: 10.1371/journal.pcbi.1010557. eCollection 2023 Dec.

    PMID: 38091350BACKGROUND
  • Poletti S, Abdoun O, Zorn J, Lutz A. Pain regulation during mindfulness meditation: Phenomenological fingerprints in novices and experts practitioners. Eur J Pain. 2021 Aug;25(7):1583-1602. doi: 10.1002/ejp.1774. Epub 2021 Apr 22.

    PMID: 33797842BACKGROUND
  • Katyal S, Abdoun O, Mounier H, Lutz A. Reduced processing of afforded actions while observing mental content as ongoing mental phenomena. Sci Rep. 2024 May 2;14(1):10130. doi: 10.1038/s41598-024-60934-6.

    PMID: 38698150BACKGROUND
  • Fucci E, Poublan-Couzardot A, Abdoun O, Lutz A. No effect of focused attention and open monitoring meditation on EEG auditory mismatch negativity in expert and novice practitioners. Int J Psychophysiol. 2022 Jun;176:62-72. doi: 10.1016/j.ijpsycho.2022.03.010. Epub 2022 Mar 28.

    PMID: 35358612BACKGROUND
  • Fucci E, Abdoun O, Lutz A. Auditory perceptual learning is not affected by anticipatory anxiety in the healthy population except for highly anxious individuals: EEG evidence. Clin Neurophysiol. 2019 Jul;130(7):1135-1143. doi: 10.1016/j.clinph.2019.04.010. Epub 2019 Apr 27.

    PMID: 31085447BACKGROUND
  • Fucci E, Abdoun O, Baquedano C, Lutz A. Ready to help, no matter what you did: Responsibility attribution does not influence compassion in expert Buddhist practitioners. J Exp Psychol Gen. 2024 Apr;153(4):1093-1111. doi: 10.1037/xge0001542. Epub 2024 Feb 22.

    PMID: 38386366BACKGROUND
  • Czajko S, Zorn J, Daumail L, Chetelat G, Margulies DS, Lutz A. Exploring the Embodied Mind: Functional Connectome Fingerprinting of Meditation Expertise. Biol Psychiatry Glob Open Sci. 2024 Aug 9;4(6):100372. doi: 10.1016/j.bpsgos.2024.100372. eCollection 2024 Nov.

    PMID: 39309211BACKGROUND
  • Abdoun O, Zorn J, Poletti S, Fucci E, Lutz A. Training novice practitioners to reliably report their meditation experience using shared phenomenological dimensions. Conscious Cogn. 2019 Feb;68:57-72. doi: 10.1016/j.concog.2019.01.004. Epub 2019 Jan 15.

    PMID: 30658238BACKGROUND

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sandrine SONIE, MD

    Le Vinatier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2017

First Posted

April 18, 2017

Study Start

March 19, 2016

Primary Completion

October 16, 2019

Study Completion

October 16, 2019

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations