Healthy VolunteersNeuCoSeNCT03206840
Neural Correlates of Self
A study of Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Despite the increasing popularity of mindfulness meditation and hypnosis in healthcare and in the general community the underlying neurobiological mechanisms are unclear. The change in the relationship between the self and the conscious experience that they bring about may be crucial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2017to 12 Nov 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-70
- Body mass index between 18.5 and 30
- Covered by health insurance
- motivated to participate
- signed informed consent
- normal or corrected-to-normal eyesight
- sufficient command of French to be able to follow the instructions
Who cannot join
- history of neurological or psychiatric conditions
- chronic pain or another medical condition altering pain perception
- use of medication that affects the central nervous system
- use of opioids or antidepressant medication
- severe auditory loss
- consumption of alcohol or intoxicants on the day of the experiments and the day preceding the experiments
- pregnancy, breastfeeding or having given birth <6months ago
- any contra-indication to Magnetic Resonance Imaging (metal implants or foreign bodies), agitation, claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neural Correlates of the " Self " in Altered States of Consciousness
Despite the increasing popularity of mindfulness meditation and hypnosis in healthcare and in the general community the underlying neurobiological mechanisms are unclear. The change in the relationship between the self and the conscious experience that they bring about may be crucial. This study aims to identify the neural correlates of self-consciousness in meta-awareness and absorption - using functional Magnetic Resonance Imaging (fMRI) in healthy participants combined with detailed first-person experiential accounts and behavioural tasks. This study will provide important clues about the widely reported effects of mindfulness meditation and hypnosis and shed light on the neural correlates of the conscious experience of self.
- Conditions
- Healthy Volunteers
- Being tested
- "control", "meditation", "hypnosis".
- Keywords
- mindfulness meditation, hypnosis, meta-awareness, absorption, consciousness, self
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"control", "meditation", "hypnosis".Behavioural
three instructions will be given to each participant: "control", "meditation", "hypnosis". The order of "meditation" and "hypnosis" will be randomized amongst two groups to avoid order effects.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | three instructions will be given to each participant: "control", "meditation", "hypnosis". The order of "meditation" and "hypnosis" will be randomized amongst two groups to avoid order effects. Receives: Behavioral: "control", "meditation", "hypnosis". |
| Group 2 | Experimental | three instructions will be given to each participant: "control", "meditation", "hypnosis". The order of "meditation" and "hypnosis" will be randomized amongst two groups to avoid order effects. Receives: Behavioral: "control", "meditation", "hypnosis". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time (minutes)
reaction times during behavioural tasks.
Measured: at day 1
Brain activation with IRM
Activation of different brain areas, as measured with functional Magnetic Resonance
Measured: At day 3
Secondary outcomes (4)
personality trait with questionnaires
scores on different personality questionnaires
Measured: at day 2
Scores during behavioural tasks
scores on likert scale (1-5 and 1-9) about intensity of the stimui presented during the task
Measured: at day 1
Scores during behavioural tasks
scores on likert scale (1-5 and 1-9) about intensity of the stimui presented during the task
Measured: at day 3
salivary volume (millimeter)
salivary volume after behavioural tasks
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start26 Oct 2017
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 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, Lyon Neuroscience Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206840
- Sponsor's protocol ID
- 69HCL17_0274
- Other IDs
- 2017-A01923-50
- Acronym
- NeuCoSe
- Status last verified
- Nov 2025
- First submitted
- 30 Jun 2017
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lutz A. Regulation of attention and emotions by meditation: neurophysiological basis and implications for mental and physical health. In: 12th BIAL Foundation Symposium "Amplified states of consciousness"; 2018 Apr 6; Porto, Portugal. Lutz A. Méditation, hypnose… se soigner par la conscience. In: INSERM - Culture scientifique (webinar); 2022 Dec 13; Paris, France (online). Lutz A. Mindfulness meditation from the lenses of phenomenology and neurosciences. In: USC Center for Mindful Science - Invited lecture; 2022 Dec 12; Los Angeles (CA), USA. Lutz A. Neurophenomenology after Varela (1996). In: Metanoia/Ouroboros - Seminar; 2021 Sep 1; (online).
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Correlates of the " Self " in Altered States of Consciousness
- ClinicalTrials.gov ID
- NCT03206840
- Acronym / sponsor ID
- NeuCoSe / 69HCL17_0274
- Conditions
- Healthy Volunteers
- Keywords
- mindfulness meditation, hypnosis, meta-awareness, absorption, consciousness, self
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 2 Jul 2017 (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.
Despite the increasing popularity of mindfulness meditation and hypnosis in healthcare and in the general community the underlying neurobiological mechanisms are unclear. The change in the relationship between the self and the conscious experience that they bring about may be crucial. This study aims to identify the neural correlates of self-consciousness in meta-awareness and absorption - using functional Magnetic Resonance Imaging (fMRI) in healthy participants combined with detailed first-person experiential accounts and behavioural tasks. This study will provide important clues about the widely reported effects of mindfulness meditation and hypnosis and shed light on the neural correlates of the conscious experience of self.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: "control", "meditation", "hypnosis".three instructions will be given to each participant: "control", "meditation", "hypnosis". The order of "meditation" and "hypnosis" will be randomized amongst two groups to avoid order effects. |
| Group 2 | Experimental | Behavioral: "control", "meditation", "hypnosis".three instructions will be given to each participant: "control", "meditation", "hypnosis". The order of "meditation" and "hypnosis" will be randomized amongst two groups to avoid order effects. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged 18-70
- Body mass index between 18.5 and 30
- Covered by health insurance
- motivated to participate
- signed informed consent
Key exclusion criteria (8 listed)
- history of neurological or psychiatric conditions
- chronic pain or another medical condition altering pain perception
- use of medication that affects the central nervous system
- use of opioids or antidepressant medication
- severe auditory loss
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 |
|---|---|---|
| "control", "meditation", "hypnosis".three instructions will be given to each participant: "control", "meditation", "hypnosis". The order of "meditation" and "hypnosis" will be randomized amongst two groups to avoid order effects. | Behavioural | Group 1, Group 2 |
Primary outcome
Reaction time (minutes)
Time frame: at day 1
reaction times during behavioural tasks.
Brain activation with IRM
Time frame: At day 3
Activation of different brain areas, as measured with functional Magnetic Resonance
4 secondary outcomes
personality trait with questionnaires
Time frame: at day 2
Scores during behavioural tasks
Time frame: at day 1
Scores during behavioural tasks
Time frame: at day 3
salivary volume (millimeter)
Time frame: at day 1
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 21 Nov 2025.
- Results publicationLutz A. Regulation of attention and emotions by meditation: neurophysiological basis and implications for mental and physical health. In: 12th BIAL Foundation Symposium "Amplified states of consciousness"; 2018 Apr 6; Porto, Portugal. Lutz A. Méditation, hypnose… se soigner par la conscience. In: INSERM - Culture scientifique (webinar); 2022 Dec 13; Paris, France (online). Lutz A. Mindfulness meditation from the lenses of phenomenology and neurosciences. In: USC Center for Mindful Science - Invited lecture; 2022 Dec 12; Los Angeles (CA), USA. Lutz A. Neurophenomenology after Varela (1996). In: Metanoia/Ouroboros - Seminar; 2021 Sep 1; (online).
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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
Lyon Neuroscience Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 7 inclusion and 8 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 21 Nov 2025. 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?
Reaction time (minutes) (time frame: at day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03206840, which also lists 1 linked publication.
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 21 Nov 2025.