Clinical trial NCT04449913: Changes in Perception and Cognition During a Meditation Retreat
Official title: Study of the Longitudinal Changes in Perception and Cognition Occurring During a Meditation Retreat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Meditation
Emotional Regulation
Metacognitive Awareness
Attention
Mindfulness
Pain
Predictive Coding
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: changes in matched forces (Newtons) during a force-matching task.
timeFrame: 1 or 2 days before the start of the retreat
measure: changes in matched forces (Newtons) during a force-matching task.
timeFrame: 7 days later
measure: changes in matched forces (Newtons) during a force-matching task.
timeFrame: at least 3 weeks after the end of the retreat
measure: changes in EEG an auditory evoked response called the mismatch negativity (microVolt)
timeFrame: 1 or 2 days before the start of the retreat
measure: changes in EEG an auditory evoked response called the mismatch negativity (microVolt)
timeFrame: 7 days later
measure: changes in EEG an auditory evoked response called the mismatch negativity (microVolt)
timeFrame: at least 3 weeks after the end of the retreat
measure: changes in EEG pain-related evoked responses (microVolt)
timeFrame: 1 or 2 days before the start of the retreat
measure: changes in EEG pain-related evoked responses (microVolt)
timeFrame: 7 days later
measure: changes in EEG pain-related evoked responses (microVolt)
timeFrame: at least 3 weeks after the end of the retreat
Secondary outcomes:
measure: Changes in perceived pain intensity during a pain paradigm
timeFrame: 1 or 2 days before the start of the retreat
measure: Changes in perceived pain intensity during a pain paradigm
timeFrame: 7 days later
measure: Changes in perceived pain intensity during a pain paradigm
timeFrame: at least 3 weeks after the end of the retreat
measure: Changes in perceived pain unpleasantness during a pain paradigm.
timeFrame: at least 3 weeks after the end of the retreat
measure: Changes in perceived pain unpleasantness during a pain paradigm.
timeFrame: 1 or 2 days before the start of the retreat
measure: Changes in perceived pain unpleasantness during a pain paradigm.
timeFrame: 7 days later
measure: Changes in BOLD functional connectivities at rest and during mindfulness meditation within and between the salience, default mode and executive brain networks
timeFrame: 1 to 7 days before the start of the retreat
measure: Changes in BOLD functional connectivities at rest and during mindfulness meditation within and between the salience, default mode and executive brain networks
timeFrame: 1 to 7 days after the end of the retreat
measure: Changes in BOLD functional connectivities at rest and during mindfulness meditation within and between the salience, default mode and executive brain networks
timeFrame: at least 3 weeks after the end of the retreat
measure: Changes in macroscale functional organization of brain BOLD activity at rest or in meditation
timeFrame: 1 to 7 days before the start of the retreat
measure: Changes in macroscale functional organization of brain BOLD activity in meditation
timeFrame: 1 to 7 days before the start of the retreat
measure: Changes in macroscale functional organization of brain BOLD activity at rest or in meditation
timeFrame: 1 to 7 days after the end of the retreat
measure: Changes in macroscale functional organization of brain BOLD activity in meditation
timeFrame: 1 to 7 days after the end of the retreat
measure: Changes in macroscale functional organization of brain BOLD activity at rest or in meditation
timeFrame: at least 3 weeks after the end of the retreat
measure: Changes in macroscale functional organization of brain BOLD activity in meditation
timeFrame: at least 3 weeks after the end of the retreat
measure: Changes in experiential thought sampling thoughout the meditation retreat.
timeFrame: every day from day 1 to day 10 of the retreat
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre de Recherche en Neuroscience de Lyon
Study officials:
affiliation: Centre de recherche de Neurosciences de Lyon (CRNL)
name: Antoine LUTZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: