Healthy VolunteersLONGIMEDNCT04449913
Changes in Perception and Cognition During a Meditation Retreat
A study testing 10 days intensive meditation retreat and Waiting for a 10 days intensive meditation retreat in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 10 days intensive meditation retreat and Waiting for a 10 days intensive meditation retreat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2020to 10 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- 10 days intensive meditation retreat, Waiting for a 10 days intensive meditation retreat
- Keywords
- Meditation, Emotional Regulation, Metacognitive Awareness, Attention, Mindfulness, Pain, Predictive Coding
- Medical subject headings
- Emotional Regulation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 days intensive meditation retreatBehavioural
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 retreatBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | 10 days intensive meditation retreat Receives: Behavioral: 10 days intensive meditation retreat |
| Control group | Other | Waiting for a 10 days intensive meditation retreat Receives: Behavioral: Waiting for a 10 days intensive meditation retreat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at least 3 weeks after the end of the retreat
Secondary outcomes (16)
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.
Measured: 1 or 2 days before the start of the retreat
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.
Measured: 7 days later
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.
Measured: at least 3 weeks after the end of the retreat
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.
Measured: at least 3 weeks after the end of the retreat
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.
Measured: 1 or 2 days before the start of the retreat
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: at least 3 weeks after the end of the retreat
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.
Measured: 1 to 7 days before the start of the retreat
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.
Measured: 1 to 7 days before the start of the retreat
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.
Measured: 1 to 7 days after the end of the retreat
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.
Measured: 1 to 7 days after the end of the retreat
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.
Measured: at least 3 weeks after the end of the retreat
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.
Measured: at least 3 weeks after the end of the retreat
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
Measured: every day from day 1 to day 10 of the retreat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start2 Oct 2020
- Primary completion10 Apr 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine LUTZ, PhD, Principal investigator, Centre de recherche de Neurosciences de Lyon (CRNL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449913
- Sponsor's protocol ID
- 69HCL20_0003
- Other IDs
- 2020-A00669-30
- Acronym
- LONGIMED
- Status last verified
- Oct 2021
- First submitted
- 24 Jun 2020
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Longitudinal Changes in Perception and Cognition Occurring During a Meditation Retreat
- ClinicalTrials.gov ID
- NCT04449913
- Acronym / sponsor ID
- LONGIMED / 69HCL20_0003
- Conditions
- Healthy Volunteers
- Keywords
- Meditation, Emotional Regulation, Metacognitive Awareness, Attention, Mindfulness, Pain, Predictive Coding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Behavioral: 10 days intensive meditation retreat10 days intensive meditation retreat |
| Control group | Other | Behavioral: Waiting for a 10 days intensive meditation retreatWaiting for a 10 days intensive meditation retreat |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 days intensive meditation retreatThe 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. | Behavioural | Active group |
| Waiting for a 10 days intensive meditation retreatAt 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. | Behavioural | Control group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
16 secondary outcomes
Changes in perceived pain intensity during a pain paradigm
Time frame: 1 or 2 days before the start of the retreat
Changes in perceived pain intensity during a pain paradigm
Time frame: 7 days later
Changes in perceived pain intensity during a pain paradigm
Time frame: 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
Changes in perceived pain unpleasantness during a pain paradigm.
Time frame: 1 or 2 days before the start of the retreat
Changes in perceived pain unpleasantness during a pain paradigm.
Time frame: 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
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
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
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
Changes in macroscale functional organization of brain BOLD activity in meditation
Time frame: 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
Changes in macroscale functional organization of brain BOLD activity in meditation
Time frame: 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
Changes in macroscale functional organization of brain BOLD activity in meditation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine LUTZ, PhD principal investigator
Centre de recherche de Neurosciences de Lyon (CRNL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 days intensive meditation retreat and Waiting for a 10 days intensive meditation retreat in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in matched forces (Newtons) during a force-matching task. (time frame: 1 or 2 days before the start of the retreat). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.