- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03117478
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
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
169
Phase
- 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
-
-
-
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
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 |
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.
|
Magneto-encephalography
Electro-encephalography
Functional Magnetic Resonance Imaging
Anatomical Magnetic Resonance Imaging
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.
|
Magneto-encephalography
Electro-encephalography
Functional Magnetic Resonance Imaging
Anatomical Magnetic Resonance Imaging
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).
|
Magneto-encephalography
Electro-encephalography
Functional Magnetic Resonance Imaging
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).
|
Magneto-encephalography
Electro-encephalography
Functional Magnetic Resonance Imaging
Anatomical Magnetic Resonance Imaging
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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)
March 19, 2016
Primary Completion (Actual)
October 16, 2019
Study Completion (Actual)
October 16, 2019
Study Registration Dates
First Submitted
February 8, 2017
First Submitted That Met QC Criteria
April 12, 2017
First Posted (Actual)
April 18, 2017
Study Record Updates
Last Update Posted (Estimated)
September 19, 2025
Last Update Submitted That Met QC Criteria
September 15, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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