Hemodynamic Correlates of Distinct Hypnotic States

November 26, 2018 updated by: Mike Bruegger

Multimodal Investigation of Distinct Hypnotic States - A Resting-State fMRI Study

The investigation will assess the brain activation connectivity patterns associated with hypnosis and possible hypnotic sub-states by means of functional magnetic resonance imaging (fMRI). For that purpose, 50 healthy participants highly familiar with hypnosis (according to the OMNI-method) will be recruited and tested.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite the growing number of studies investigating of the physiological underpinnings of hypnosis by means of neuroimaging methods such as electroencephalography (EEG) positron emission tomography (PET) and functional magnetic resonance imaging (fMRI), still no consensus exists regarding the underlying neurophysiological working mechanisms due to high levels of variability in the data.

Generally, the variability observed in research examining the neurobiological fundamentals of hypnosis could be attributed to the following characteristics:

  1. Heterogeneity regarding hypnotic induction procedures.
  2. Insufficient statistical power.
  3. Mono-Modality: Studies investigating the neurophysiologic mechanisms of hypnosis typically apply only one method for the investigation of their research questions. However, different techniques complement each other, hence, resulting in a more thorough understanding of the mechanisms of action.

In this project, the investigators present a multimodal approach, in which these three points are considered in order to provide a comprehensive picture with respect to psycho- and neurophysiologic fundamentals of hypnosis and proposed distinct hypnotic states.

Point 1) will be approached by applying a highly reproducible method for the hypnotic induction (OMNI-hypnosis). This hypnosis method is fast, direct and all OMNI educated hypnotherapists follow exactly the same induction procedure. This implies a high level of standardization and operationalization, crucial prerequisites to investigate the phenomenon based on scientific guidelines.

Point 2) will be addressed by including a homogeneous study sample of 50 highly suggestible participants. Furthermore, the comparably high number of 50 participants should ensure sufficient statistical power particularly in consideration of the homogeneity of the study sample.

Point 3) is addressed by following a multimodal approach combining a vast array of psychophysiological measures with multimodal neuroimaging. For that purpose, the project will be divided into three studies: A EEG- and psychophysiological study, a fMRI-study and a magnetic resonance spectroscopy (1H-MRS) study.

In the present study, fMRI is applied for the investigation of network dynamics associated with hypnotic states. Hypnotic states will be compared to control states which follow mock instructions matched to the hypnosis instructions.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • University of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 18 and 65
  • Proficient in German language
  • Written informed consent after being informed
  • Familiar with hypnotic states of OMNI-Hypnosis

Exclusion Criteria:

  • Pre-existing neurological and/or psychiatric conditions
  • History of brain injuries
  • Alcohol and/or drug abuse
  • Chronic diseases that require a permanent intake of drugs

Additional exclusion criteria for the MRI- and 1H-MRS-experiment:

  • General contraindications for a participation on a MRI-Experiment (e.g. claustrophobia, pace maker, cochlea implants, insulin pumps)
  • Hypersensitivity to loud noise
  • Not being able to lie still during a longer period of time
  • Foreign metallic objects in the body (e.g. gunshot wounds, metallic particles, metal implants, irremovable piercings)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Subjects

The study has a 2 (Intervention: Hypnosis, Control) x 2 (State: 1 & 2) factorial within-subjects design, resulting in a total of 4 conditions. All volunteers participate at the 4 conditions in the same session.The order of the interventions is counterbalanced resulting in two possible sequences:

Sequence 1: Hypnosis State 1, Hypnosis State 2, Control State 1, Control State 2

Sequence 2: Control State 1, Control State2, Hypnosis State 1, Hypnosis State 2

Volunteers will be randomly allocated to the two sequence types.
Procedure: Hypnosis
The hypnosis intervention consists of two elements: A hypnotic induction and a hypnotic deepening. The induction aims at guiding the participant into the first hypnotic state (state 1). The participants will remain in this state for 10 minutes, the duration of the fMRI-scan. The hypnotic deepening guides the participants into a very deep hypnotic state (state 2). Participants also remain in this state for 10 minutes, during which their brain activity is measured using fMRI
Procedure: Control
The control intervention consists of texts corresponding to the induction and deepening of the hypnosis intervention. They are matched in duration and consist of textually matched excerpts from www.wikipedia.org. Control induction will be presented, resulting in the control state 1 (10 min). Then the control deepening will be performed, leading to the control state 2 (10 minutes). During both control states the brain activity will be recorded using fMRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in resting state functional connectivity (assessed using fMRI) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
Time Frame: 90 minutes
90 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in heart rate variability (assessed during fMRI measurements) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
Time Frame: 90 minutes
90 minutes
Differences respiratory frequency (assessed during fMRI measurements) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
Time Frame: 90 minutes
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mike Bruegger

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HypnoScienceMRI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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