Clinical trial NCT03568227: Hemodynamic Correlates of Distinct Hypnotic States
Official title: Multimodal Investigation of Distinct Hypnotic States - A Resting-State fMRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypnosis
Keywords: Hypnosis
Neurophysiology
fMRI
Resting-State
Hypnotic Sub-States
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in resting state functional connectivity (assessed using fMRI) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
timeFrame: 90 minutes
Secondary outcomes:
measure: Differences in heart rate variability (assessed during fMRI measurements) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
timeFrame: 90 minutes
measure: Differences respiratory frequency (assessed during fMRI measurements) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References:
citation: Elkins GR, Barabasz AF, Council JR, Spiegel D. Advancing research and practice: the revised APA Division 30 definition of hypnosis. Int J Clin Exp Hypn. 2015;63(1):1-9. doi: 10.1080/00207144.2014.961870.
citation: Jensen MP, Jamieson GA, Lutz A, Mazzoni G, McGeown WJ, Santarcangelo EL, Demertzi A, De Pascalis V, Banyai EI, Rominger C, Vuilleumier P, Faymonville ME, Terhune DB. New directions in hypnosis research: strategies for advancing the cognitive and clinical neuroscience of hypnosis. Neurosci Conscious. 2017;3(1):nix004. doi: 10.1093/nc/nix004. Epub 2017 Apr 12.
citation: McGeown WJ, Mazzoni G, Vannucci M, Venneri A. Structural and functional correlates of hypnotic depth and suggestibility. Psychiatry Res. 2015 Feb 28;231(2):151-9. doi: 10.1016/j.pscychresns.2014.11.015. Epub 2014 Dec 6.
citation: Terhune DB, Cleeremans A, Raz A, Lynn SJ. Hypnosis and top-down regulation of consciousness. Neurosci Biobehav Rev. 2017 Oct;81(Pt A):59-74. doi: 10.1016/j.neubiorev.2017.02.002. Epub 2017 Feb 4.
citation: Varga K, Kekecs Z, Myhre PS, Jozsa E. A Neutral Control Condition for Hypnosis Experiments: "Wiki" Text. Int J Clin Exp Hypn. 2017 Oct-Dec;65(4):429-451. doi: 10.1080/00207144.2017.1348833.