Changes in Perception and Cognition During a Meditation Retreat

Healthy Volunteers Clinical Trial

— LONGIMED  

Official title:

Study of the Longitudinal Changes in Perception and Cognition Occurring During a Meditation Retreat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449913
• Other study ID #: 69HCL20_0003
• Secondary ID: 2020-A00669-30
• Status: Completed
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: April 10, 2021

Study information

• Verified date: October 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 10, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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-un e-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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
France	Centre de Recherche en Neuroscience de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in matched forces (Newtons) during a force-matching task.	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
Primary	changes in matched forces (Newtons) during a force-matching task.	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
Primary	changes in matched forces (Newtons) during a force-matching task.	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
Primary	changes in EEG an auditory evoked response called the mismatch negativity (microVolt)	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
Primary	changes in EEG an auditory evoked response called the mismatch negativity (microVolt)	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
Primary	changes in EEG an auditory evoked response called the mismatch negativity (microVolt)	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
Primary	changes in EEG pain-related evoked responses (microVolt)	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
Primary	changes in EEG pain-related evoked responses (microVolt)	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
Primary	changes in EEG pain-related evoked responses (microVolt)	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	Changes in perceived pain intensity during a pain paradigm	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
Secondary	Changes in perceived pain intensity during a pain paradigm	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
Secondary	Changes in perceived pain intensity during a pain paradigm	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
Secondary	Changes in perceived pain unpleasantness during a pain paradigm.	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
Secondary	Changes in perceived pain unpleasantness during a pain paradigm.	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
Secondary	Changes in perceived pain unpleasantness during a pain paradigm.	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
Secondary	Changes in BOLD functional connectivities at rest and during mindfulness meditation within and between the salience, default mode and executive brain networks	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
Secondary	Changes in BOLD functional connectivities at rest and during mindfulness meditation within and between the salience, default mode and executive brain networks	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
Secondary	Changes in BOLD functional connectivities at rest and during mindfulness meditation within and between the salience, default mode and executive brain networks	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
Secondary	Changes in macroscale functional organization of brain BOLD activity at rest or in meditation	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
Secondary	Changes in macroscale functional organization of brain BOLD activity in meditation	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
Secondary	Changes in macroscale functional organization of brain BOLD activity at rest or in meditation	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
Secondary	Changes in macroscale functional organization of brain BOLD activity in meditation	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
Secondary	Changes in macroscale functional organization of brain BOLD activity at rest or in meditation	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
Secondary	Changes in macroscale functional organization of brain BOLD activity in meditation	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
Secondary	Changes in experiential thought sampling thoughout the meditation 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