- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04449913
Changes in Perception and Cognition During a Meditation Retreat (LONGIMED)
October 26, 2021 updated by: Hospices Civils de Lyon
Study of the Longitudinal Changes in Perception and Cognition Occurring During a Meditation Retreat
This study aims at assessing neuro-behavioral changes occuring during an intensive ten days meditation retreat.
The investigator will study changes in tactile, auditory and pain perceptions as well as changes in cognitive and affective mental contents and their neural markers, as measured by self-reports, EEG event-related potentials, and functional connectivity of resting state fMRI.
He will recruit healthy participants with a prior meditation experience.
They will be randomly assigned to two groups, one active group who will undergo measurements just before, during and 3 weeks after the retreat.
The other group will serve of control for task habituation, control participants will undergo the same measurements, equally spaced in time, but before the retreat.
The main hypothesis is that meditation training strengthens meta-awareness, attention capacities resulting in enhanced bodily- and self-awareness during sensory perception and emotion regulation during pain.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
58
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
- Centre de Recherche en Neuroscience de Lyon
-
-
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
18 years to 67 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 18 and 67
- Regular meditation practice (at least 20 minutes 3 times a week) arising from a formal teaching (buddhist tradition, MBSR, mindfulness) for at least one year.
- Having taken part to at least one intensive retreat (more than six hours of sitting meditation a day, during at least two days) in the past.
- Affiliated to french social security
- Motivated to take part in the study
- Having signed an informed consent
- Normal or corrected vision
- Sufficient mastering of French to be able to understand correctly written and auditory instructions
Exclusion Criteria:
- neurological or psychiatric antecedents
- chronical pain or any other medical condition giving rise to acute pain or sensitivity to pain.
- Motor or sensory deficit in the hands
- severe auditory loss
- regularly taking medical drugs acting on the central nervous system
- regularly taking opioids or antidepressant drugs
- alcohol consumption above the safety threshold recognized by the French healthy agency (10 drinks a week, 2 drinks a day, 5 drinks for special occasions)
- drugs consumption (except tabacco) qualified as addictive according to medical criteria (https://www.drogues.gouv.fr/comprendre/l-essentiel-sur-les-addictions/qu-est-ce-qu-une-addiction)
- alcohol or drug consumption the day before or the day of experiment and during the full duration of the retreat
- being pregnant, breastfeading or having given birth less than 6 months ago
- Will be excluded from the fMRI task only, participants presenting contraindication to a MRI scan : being claustrophobic, body mass index over 30, people, having a pacemaker or an insuline pump, metallic prothesis, intracranial clip, neurosensory stimulator, in-body defibrillator, cochlear implants, ocular or brain feromagnetic bodies close to nervous structures, neurosurgery stunts, dental brace.
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Active group
10 days intensive meditation retreat
|
The intervention consists in a 10 days contemplative retreat, with 6 to 8 hours of sitting and walking meditation per day, and 1 or 2 hours of meditation teachings.
The meditation practice will mainly train in mindfulness practice.
Mindfulness meditation intends to train attention to detect and regulate afflictive cognitive and emotional patterns.
Mindfulness practice requires skills involved in openness to experience, in monitoring the focus of attention and in detecting distraction, disengaging attention from the source of distraction, and flexibly (re)directing and engaging attention to the intended object.
A brief introduction to loving-kindness and compassion meditation will also be present throughout the retreat.
|
OTHER: Control group
Waiting for a 10 days intensive meditation retreat
|
At the time of measure, participants in this group are waiting to participate to the same meditation retreat as the active group.
They may perform their own daily meditation practices as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in matched forces (Newtons) during a force-matching task.
Time Frame: 1 or 2 days before the start of the retreat
|
Bodily awareness following meditation training could impact the attenuation of real tactile sensations during self-generated touch.
Measurement of pressure force will be done through a force-matching paradigm.
|
1 or 2 days before the start of the retreat
|
changes in matched forces (Newtons) during a force-matching task.
Time Frame: 7 days later
|
Bodily awareness following meditation training could impact the attenuation of real tactile sensations during self-generated touch.
Measurement of pressure force will be done through a force-matching paradigm.
|
7 days later
|
changes in matched forces (Newtons) during a force-matching task.
Time Frame: at least 3 weeks after the end of the retreat
|
Bodily awareness following meditation training could impact the attenuation of real tactile sensations during self-generated touch.
Measurement of pressure force will be done through a force-matching paradigm.
|
at least 3 weeks after the end of the retreat
|
changes in EEG an auditory evoked response called the mismatch negativity (microVolt)
Time Frame: 1 or 2 days before the start of the retreat
|
Moment-to-moment monitoring following meditation training could downregulate the automatic formation of perceptual habits.
Measurement of auditory evoked potentials will be done through Biosemi 64 electrodes EEG net during an auditory oddball task.
|
1 or 2 days before the start of the retreat
|
changes in EEG an auditory evoked response called the mismatch negativity (microVolt)
Time Frame: 7 days later
|
Moment-to-moment monitoring following meditation training could downregulate the automatic formation of perceptual habits.
Measurement of auditory evoked potentials will be done through Biosemi 64 electrodes EEG net during an auditory oddball task.
|
7 days later
|
changes in EEG an auditory evoked response called the mismatch negativity (microVolt)
Time Frame: at least 3 weeks after the end of the retreat
|
Moment-to-moment monitoring following meditation training could downregulate the automatic formation of perceptual habits.
Measurement of auditory evoked potentials will be done through Biosemi 64 electrodes EEG net during an auditory oddball task.
|
at least 3 weeks after the end of the retreat
|
changes in EEG pain-related evoked responses (microVolt)
Time Frame: 1 or 2 days before the start of the retreat
|
Moment-to-moment monitoring and emotion regulation following meditation training could downregulate pain catastrophizing.
Measurement pain-related evoked potentials will be done through Biosemi 64 electrodes EEG net during a pain characterization task.
|
1 or 2 days before the start of the retreat
|
changes in EEG pain-related evoked responses (microVolt)
Time Frame: 7 days later
|
Moment-to-moment monitoring and emotion regulation following meditation training could downregulate pain catastrophizing.
Measurement pain-related evoked potentials will be done through Biosemi 64 electrodes EEG net during a pain characterization task.
|
7 days later
|
changes in EEG pain-related evoked responses (microVolt)
Time Frame: at least 3 weeks after the end of the retreat
|
Moment-to-moment monitoring and emotion regulation following meditation training could downregulate pain catastrophizing.
Measurement pain-related evoked potentials will be done through Biosemi 64 electrodes EEG net during a pain characterization task.
|
at least 3 weeks after the end of the retreat
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in perceived pain intensity during a pain paradigm
Time Frame: 1 or 2 days before the start of the retreat
|
Moment-to-moment monitoring and emotion regulation following meditation training could regulate the cognitive-affective pain amplificatory processes.
Scales ranging from no intensity or unpleasantness, to highest pain intensity or unpleasantness experienced in life will be used during a pain characterization task.
|
1 or 2 days before the start of the retreat
|
Changes in perceived pain intensity during a pain paradigm
Time Frame: 7 days later
|
Moment-to-moment monitoring and emotion regulation following meditation training could regulate the cognitive-affective pain amplificatory processes.
Scales ranging from no intensity or unpleasantness, to highest pain intensity or unpleasantness experienced in life will be used during a pain characterization task.
|
7 days later
|
Changes in perceived pain intensity during a pain paradigm
Time Frame: at least 3 weeks after the end of the retreat
|
Moment-to-moment monitoring and emotion regulation following meditation training could regulate the cognitive-affective pain amplificatory processes.
Scales ranging from no intensity or unpleasantness, to highest pain intensity or unpleasantness experienced in life will be used during a pain characterization task.
|
at least 3 weeks after the end of the retreat
|
Changes in perceived pain unpleasantness during a pain paradigm.
Time Frame: at least 3 weeks after the end of the retreat
|
Moment-to-moment monitoring and emotion regulation following meditation training could regulate the cognitive-affective pain amplificatory processes.
Scales ranging from no intensity or unpleasantness, to highest pain intensity or unpleasantness experienced in life will be used during a pain characterization task.
|
at least 3 weeks after the end of the retreat
|
Changes in perceived pain unpleasantness during a pain paradigm.
Time Frame: 1 or 2 days before the start of the retreat
|
Moment-to-moment monitoring and emotion regulation following meditation training could regulate the cognitive-affective pain amplificatory processes.
Scales ranging from no intensity or unpleasantness, to highest pain intensity or unpleasantness experienced in life will be used during a pain characterization task.
|
1 or 2 days before the start of the retreat
|
Changes in perceived pain unpleasantness during a pain paradigm.
Time Frame: 7 days later
|
Moment-to-moment monitoring and emotion regulation following meditation training could regulate the cognitive-affective pain amplificatory processes.
Scales ranging from no intensity or unpleasantness, to highest pain intensity or unpleasantness experienced in life will be used during a pain characterization task.
|
7 days later
|
Changes in BOLD functional connectivities at rest and during mindfulness meditation within and between the salience, default mode and executive brain networks
Time Frame: 1 to 7 days before the start of the retreat
|
Moment-to-moment monitoring following meditation training could regulate different attention related brain networks.
Brain structural anatomy will be recorded in a 3-Tesla fMRI scaner during rest, and BOLD signal activation during rest and meditation states.
|
1 to 7 days before the start of the retreat
|
Changes in BOLD functional connectivities at rest and during mindfulness meditation within and between the salience, default mode and executive brain networks
Time Frame: 1 to 7 days after the end of the retreat
|
Moment-to-moment monitoring following meditation training could regulate different attention related brain networks.
Brain structural anatomy will be recorded in a 3-Tesla fMRI scaner during rest, and BOLD signal activation during rest and meditation states.
|
1 to 7 days after the end of the retreat
|
Changes in BOLD functional connectivities at rest and during mindfulness meditation within and between the salience, default mode and executive brain networks
Time Frame: at least 3 weeks after the end of the retreat
|
Moment-to-moment monitoring following meditation training could regulate different attention related brain networks.
Brain structural anatomy will be recorded in a 3-Tesla fMRI scaner during rest, and BOLD signal activation during rest and meditation states.
|
at least 3 weeks after the end of the retreat
|
Changes in macroscale functional organization of brain BOLD activity at rest or in meditation
Time Frame: 1 to 7 days before the start of the retreat
|
Moment-to-moment monitoring following meditation training could regulate different attention related brain networks.
Brain structural anatomy will be recorded in a 3-Tesla fMRI scaner during rest, and BOLD signal activation during rest and meditation states.
|
1 to 7 days before the start of the retreat
|
Changes in macroscale functional organization of brain BOLD activity in meditation
Time Frame: 1 to 7 days before the start of the retreat
|
Moment-to-moment monitoring following meditation training could regulate different attention related brain networks.
Brain structural anatomy will be recorded in a 3-Tesla fMRI scaner during rest, and BOLD signal activation during rest and meditation states.
|
1 to 7 days before the start of the retreat
|
Changes in macroscale functional organization of brain BOLD activity at rest or in meditation
Time Frame: 1 to 7 days after the end of the retreat
|
Moment-to-moment monitoring following meditation training could regulate different attention related brain networks.
Brain structural anatomy will be recorded in a 3-Tesla fMRI scaner during rest, and BOLD signal activation during rest and meditation states.
|
1 to 7 days after the end of the retreat
|
Changes in macroscale functional organization of brain BOLD activity in meditation
Time Frame: 1 to 7 days after the end of the retreat
|
Moment-to-moment monitoring following meditation training could regulate different attention related brain networks.
Brain structural anatomy will be recorded in a 3-Tesla fMRI scaner during rest, and BOLD signal activation during rest and meditation states.
|
1 to 7 days after the end of the retreat
|
Changes in macroscale functional organization of brain BOLD activity at rest or in meditation
Time Frame: at least 3 weeks after the end of the retreat
|
Moment-to-moment monitoring following meditation training could regulate different attention related brain networks.
Brain structural anatomy will be recorded in a 3-Tesla fMRI scaner during rest, and BOLD signal activation during rest and meditation states.
|
at least 3 weeks after the end of the retreat
|
Changes in macroscale functional organization of brain BOLD activity in meditation
Time Frame: at least 3 weeks after the end of the retreat
|
Moment-to-moment monitoring following meditation training could regulate different attention related brain networks.
Brain structural anatomy will be recorded in a 3-Tesla fMRI scaner during rest, and BOLD signal activation during rest and meditation states.
|
at least 3 weeks after the end of the retreat
|
Changes in experiential thought sampling thoughout the meditation retreat.
Time Frame: every day from day 1 to day 10 of the retreat
|
Moment-to-moment monitoring of thougts and emotions during intensive meditation training could regulate mind-wandering and mood.
Different scales of thoughts content, emotional valence and awareness of them will be recorded
|
every day from day 1 to day 10 of the retreat
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antoine LUTZ, PhD, Centre de recherche de Neurosciences de Lyon (CRNL)
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)
October 2, 2020
Primary Completion (ACTUAL)
April 10, 2021
Study Completion (ACTUAL)
April 10, 2021
Study Registration Dates
First Submitted
June 24, 2020
First Submitted That Met QC Criteria
June 24, 2020
First Posted (ACTUAL)
June 29, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 27, 2021
Last Update Submitted That Met QC Criteria
October 26, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL20_0003
- 2020-A00669-30 (OTHER: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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