NCT04449913

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Oct 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

June 24, 2020

Last Update Submit

October 26, 2021

Conditions

Keywords

MeditationEmotional RegulationMetacognitive AwarenessAttentionMindfulnessPainPredictive Coding

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (16)

  • Changes in perceived pain intensity during a pain paradigm

    1 or 2 days before the start of the retreat

  • Changes in perceived pain intensity during a pain paradigm

    7 days later

  • Changes in perceived pain intensity during a pain paradigm

    at least 3 weeks after the end of the retreat

  • Changes in perceived pain unpleasantness during a pain paradigm.

    at least 3 weeks after the end of the retreat

  • Changes in perceived pain unpleasantness during a pain paradigm.

    1 or 2 days before the start of the retreat

  • +11 more secondary outcomes

Study Arms (2)

Active group

EXPERIMENTAL

10 days intensive meditation retreat

Behavioral: 10 days intensive meditation retreat

Control group

OTHER

Waiting for a 10 days intensive meditation retreat

Behavioral: Waiting for a 10 days intensive meditation retreat

Interventions

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.

Active group

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.

Control group

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Neuroscience de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Emotional RegulationPain

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antoine LUTZ, PhD

    Centre de recherche de Neurosciences de Lyon (CRNL)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 29, 2020

Study Start

October 2, 2020

Primary Completion

April 10, 2021

Study Completion

April 10, 2021

Last Updated

October 27, 2021

Record last verified: 2021-10

Locations