Healthy VolunteersHYPNOTENCT04020731
Physiological Changes Exploration During the Hypnotic State
A study testing Hypnosis in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Use of hypnosis for therapeutic purposes tends to spread. However, the neural mechanisms underlying hypnosis is still debated and no specific change has yet been associated with this state. In this context, it seems necessary to clarify its mechanisms and effects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 23 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Right-handed
- Non-smoking
- Major participants
- Speaking fluent French
- No experience of hypnosis or other forms of meditation and relaxation
- Registered in the French social security scheme
- Signed informed consent
Who cannot join
- Contraindication to Magnetoencephalography (MEG) and/or Magnetic resonance imaging (MRI) : implanted material, claustrophobia,…
- Treatment that may impact physiological measures (psychotropic, cardiovascular,…)
- All categories of protected persons (Pregnant or lactating women, persons subject to a legal protection measure, persons deprived of their liberty by judicial or administrative decision)
- Smokers
- Persons with personality disorders or addictions / narcotic use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Changes Exploration During the Hypnotic State (HYPNOTE)
Use of hypnosis for therapeutic purposes tends to spread. However, the neural mechanisms underlying hypnosis is still debated and no specific change has yet been associated with this state. In this context, it seems necessary to clarify its mechanisms and effects. Since hypnosis induces a change of consciousness state, the investigators hypothesize that this modification is accompanied by neural activity changes recordable with magnetoencephalography (MEG). The primary objective of this study is to identify neural activity changes during hypnotic trance in healthy volunteers.
Read the detailed description
Since the 19th century, the potential changes induced by hypnosis have been investigated. Indeed, hypnosis induces a change on the usual state of conscious awareness. This state is accompanied by physiological changes, as cardiac and cerebral. However, although literature on the neural mechanisms underlying hypnosis increases, no specific activity change has been identified. Only the subjective judgment of hypnotherapist can assume the volunteer state. Considering that the use of hypnosis enhanced in the field of medical care, it is necessary to clarify and define it. This requires a better understanding of its mechanisms through the study of brain, heart and respiratory activities.
The aim of this clinical trial is to assess modifications of physiological signals (cardiac, respiratory and cerebral) before and during a session of hypnosis, to identify some biomarkers of the hypnotic trance. Therefore the cardiac, respiratory and cerebral activities will be recorded during hypnosis sessions and control state to compare the signals.
The MEG will be used to record brain activity due to its sensitivity in the very low and high frequencies, its temporal resolution and its robustness for the localization of neural origins. In accordance with the literature and preliminary results, changes in theta oscillations (4-8 Hz) will be assessed. In fact, these oscillations seem to be increased during the hypnotic state. So, it seems interesting to correlate these oscillations with potential changes in heart and/or respiratory rhythms.
This clinical trial is an open mono-centric study, performed on a cohort of healthy volunteers in which each subject is his own control (intra-subject control). The physiological parameters will be recorded and analyzed during three control states ("subject alone", "subject and hypnotherapist without communication" and "reading a book by the hypnotherapist"), and several blocks of hypnosis interleaved with an attentional task (stroop). All the collected parameters in these different conditions will be compared.
- Conditions
- Healthy Volunteers
- Being tested
- Hypnosis
- Keywords
- Hypnosis, MEG, Auditory Evoked Magnetic Fields, Oscillatory activity, Networks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
several blocks of hypnosis including entry into a hypnotic state (= induction), the hypnotic trance and the exit from hypnosis (= reassociation).
| Study group | Role | What they receive |
|---|---|---|
| Right-handed healthy volunteers | Experimental | Magnetoencephalography (MEG) records Receives: Behavioral: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural activity changes recorded by magnetoencephalography (MEG) during hypnotic trance, in healthy volunteers.
Oscillatory activity will be recorded by magnetoencephalography (MEG) : power averages of oscillations (delta, theta, alpha, beta and gamma) and phase values recorded during hypnotic trance will be compared to control conditions.
Measured: 2 hours
Secondary outcomes (3)
Neural networks activity changes recorded by magnetoencephalography (MEG) during hypnotic trance, in healthy volunteers.
Power average (Grad : fT²/Hz MAG : fT²/cm².Hz) of neuronal sources and correlations of sources activity for the Default Model Network (DMN) will be compared between hypnosis trance and control conditions.
Measured: 2 hours
Changes in auditory evoked magnetic fields (MAEF), recorded by magnetoencephalography (MEG) during hypnotic trance, in healthy volunteers.
Global averages of MAEF (Grad : fT/(cm.√Hz) MAG : fT/√Hz) will be compared between hypnosis trance and control conditions.
Measured: 2 hours
Cardiac and respiratory changes in link to neural activity changes observed during the hypnotic trance
Variations in heart rate and respiratory parameters (Hz) with neural activity changes previously described (ie: oscillatory activity, network activities (Grad : fT²/Hz MAG : fT²/cm².Hz) and MAEF (Grad : fT/(cm.√Hz) MAG : fT/√Hz)), will be compared between hypnosis trance and control conditions
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Dec 2019
- Primary completion1 Apr 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 University Hospital, GrenobleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020731
- Sponsor's protocol ID
- 38RC19.060
- Acronym
- HYPNOTE
- Status last verified
- May 2022
- First submitted
- 21 Jun 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Pascalis V, Ray WJ, Tranquillo I, D'Amico D. EEG activity and heart rate during recall of emotional events in hypnosis: relationships with hypnotizability and suggestibility. Int J Psychophysiol. 1998 Aug;29(3):255-75. doi: 10.1016/s0167-8760(98)00009-9.
PubMed 9666380Vanhaudenhuyse A, Laureys S, Faymonville ME. Neurophysiology of hypnosis. Neurophysiol Clin. 2014 Oct;44(4):343-53. doi: 10.1016/j.neucli.2013.09.006. Epub 2013 Oct 29.
PubMed 25306075Jensen MP, Adachi T, Hakimian S. Brain Oscillations, Hypnosis, and Hypnotizability. Am J Clin Hypn. 2015 Jan;57(3):230-53. doi: 10.1080/00029157.2015.985573.
PubMed 25928684Zeev-Wolf M, Dor-Ziderman Y, Goldstein A, Bonne O, Abramowitz EG. Oscillatory brain mechanisms of the hypnotically-induced out-of-body experience. Cortex. 2017 Nov;96:19-30. doi: 10.1016/j.cortex.2017.08.025. Epub 2017 Aug 31.
PubMed 28961523
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Changes Exploration During the Hypnotic State (HYPNOTE)
- ClinicalTrials.gov ID
- NCT04020731
- Acronym / sponsor ID
- HYPNOTE / 38RC19.060
- Conditions
- Healthy Volunteers
- Keywords
- Hypnosis, MEG, Auditory Evoked Magnetic Fields, Oscillatory activity, Networks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 16 Jul 2019 (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.
Use of hypnosis for therapeutic purposes tends to spread. However, the neural mechanisms underlying hypnosis is still debated and no specific change has yet been associated with this state. In this context, it seems necessary to clarify its mechanisms and effects. Since hypnosis induces a change of consciousness state, the investigators hypothesize that this modification is accompanied by neural activity changes recordable with magnetoencephalography (MEG). The primary objective of this study is to identify neural activity changes during hypnotic trance in healthy volunteers.
Detailed description
Since the 19th century, the potential changes induced by hypnosis have been investigated. Indeed, hypnosis induces a change on the usual state of conscious awareness. This state is accompanied by physiological changes, as cardiac and cerebral. However, although literature on the neural mechanisms underlying hypnosis increases, no specific activity change has been identified. Only the subjective judgment of hypnotherapist can assume the volunteer state. Considering that the use of hypnosis enhanced in the field of medical care, it is necessary to clarify and define it. This requires a better understanding of its mechanisms through the study of brain, heart and respiratory activities.
The aim of this clinical trial is to assess modifications of physiological signals (cardiac, respiratory and cerebral) before and during a session of hypnosis, to identify some biomarkers of the hypnotic trance. Therefore the cardiac, respiratory and cerebral activities will be recorded during hypnosis sessions and control state to compare the signals.
The MEG will be used to record brain activity due to its sensitivity in the very low and high frequencies, its temporal resolution and its robustness for the localization of neural origins. In accordance with the literature and preliminary results, changes in theta oscillations (4-8 Hz) will be assessed. In fact, these oscillations seem to be increased during the hypnotic state. So, it seems interesting to correlate these oscillations with potential changes in heart and/or respiratory rhythms.
This clinical trial is an open mono-centric study, performed on a cohort of healthy volunteers in which each subject is his own control (intra-subject control). The physiological parameters will be recorded and analyzed during three control states ("subject alone", "subject and hypnotherapist without communication" and "reading a book by the hypnotherapist"), and several blocks of hypnosis interleaved with an attentional task (stroop). All the collected parameters in these different conditions will be compared.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Right-handed healthy volunteers | Experimental | Behavioral: HypnosisMagnetoencephalography (MEG) records |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy volunteers
- Right-handed
- Non-smoking
- Major participants
- Speaking fluent French
Key exclusion criteria (5 listed)
- Contraindication to Magnetoencephalography (MEG) and/or Magnetic resonance imaging (MRI) : implanted material, claustrophobia,…
- Treatment that may impact physiological measures (psychotropic, cardiovascular,…)
- All categories of protected persons (Pregnant or lactating women, persons subject to a legal protection measure, persons deprived of their liberty by judicial or administrative decision)
- Smokers
- Persons with personality disorders or addictions / narcotic use
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 |
|---|---|---|
| Hypnosisseveral blocks of hypnosis including entry into a hypnotic state (= induction), the hypnotic trance and the exit from hypnosis (= reassociation). | Behavioural | Right-handed healthy volunteers |
Primary outcome
Neural activity changes recorded by magnetoencephalography (MEG) during hypnotic trance, in healthy volunteers.
Time frame: 2 hours
Oscillatory activity will be recorded by magnetoencephalography (MEG) : power averages of oscillations (delta, theta, alpha, beta and gamma) and phase values recorded during hypnotic trance will be compared to control conditions.
3 secondary outcomes
Neural networks activity changes recorded by magnetoencephalography (MEG) during hypnotic trance, in healthy volunteers.
Time frame: 2 hours
Changes in auditory evoked magnetic fields (MAEF), recorded by magnetoencephalography (MEG) during hypnotic trance, in healthy volunteers.
Time frame: 2 hours
Cardiac and respiratory changes in link to neural activity changes observed during the hypnotic trance
Time frame: 2 hours
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 18 May 2022.
- Background: PubMed 9666380De Pascalis V, Ray WJ, Tranquillo I, D'Amico D. EEG activity and heart rate during recall of emotional events in hypnosis: relationships with hypnotizability and suggestibility. Int J Psychophysiol. 1998 Aug;29(3):255-75. doi: 10.1016/s0167-8760(98)00009-9.
- Background: PubMed 25306075Vanhaudenhuyse A, Laureys S, Faymonville ME. Neurophysiology of hypnosis. Neurophysiol Clin. 2014 Oct;44(4):343-53. doi: 10.1016/j.neucli.2013.09.006. Epub 2013 Oct 29.
- Background: PubMed 25928684Jensen MP, Adachi T, Hakimian S. Brain Oscillations, Hypnosis, and Hypnotizability. Am J Clin Hypn. 2015 Jan;57(3):230-53. doi: 10.1080/00029157.2015.985573.
- Background: PubMed 28961523Zeev-Wolf M, Dor-Ziderman Y, Goldstein A, Bonne O, Abramowitz EG. Oscillatory brain mechanisms of the hypnotically-induced out-of-body experience. Cortex. 2017 Nov;96:19-30. doi: 10.1016/j.cortex.2017.08.025. Epub 2017 Aug 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Healthy Volunteers, run by University Hospital, Grenoble 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 5 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 18 May 2022. 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?
Neural activity changes recorded by magnetoencephalography (MEG) during hypnotic trance, in healthy volunteers. (time frame: 2 hours). 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 NCT04020731, which also lists 4 linked publications.
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 18 May 2022.