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Completed

NCT Number: NCT04020731

Physiological Changes Exploration During the Hypnotic State

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinatec Cea/Chuga

Grenoble, 38054, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

hypnosis

Behavioral

several blocks of hypnosis including entry into a hypnotic state (= induction), the hypnotic trance and the exit from hypnosis (= reassociation).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Neural networks activity changes recorded by magnetoencephalography (MEG) during hypnotic trance, in healthy volunteers.

    Time frame: 2 hours

    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.

  2. Changes in auditory evoked magnetic fields (MAEF), recorded by magnetoencephalography (MEG) during hypnotic trance, in healthy volunteers.

    Time frame: 2 hours

    Global averages of MAEF (Grad : fT/(cm.√Hz) MAG : fT/√Hz) will be compared between hypnosis trance and control conditions.

  3. Cardiac and respiratory changes in link to neural activity changes observed during the hypnotic trance

    Time frame: 2 hours

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Commissariat A L'energie Atomique

Registry information

Official study title

Physiological Changes Exploration During the Hypnotic State (HYPNOTE)

Acronym: HYPNOTE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2019
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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