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临床试验/NCT03568227
NCT03568227已完成不适用

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

Mike Bruegger2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Differences in resting state functional connectivity (assessed using fMRI) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Differences in resting state functional connectivity (assessed using fMRI) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)

时间窗: 90 minutes

次要结局

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

研究者

发起方
Mike Bruegger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mike Bruegger

Senior Researcher

University of Zurich

研究点 (2)

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