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临床试验/NCT02615119
NCT02615119已完成不适用

Neural Basis of Meal Related Interoceptive Dysfunction in Anorexia Nervosa

Laureate Institute for Brain Research, Inc.1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2015年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
1
主要终点
Change in cardiorespiratory sensation intensity

研究概览

简要总结

This study aims to identify the brain regions responsible for encoding cardiorespiratory 'interoceptive' sensations and determine whether they are dysfunctional in individuals affected by eating disorders, anxiety, depression, or brain injury. By evaluating the same interoceptive sensations across different human illnesses, the investigators hope to provide convergent evidence resulting in identification of core underlying neural processes, and to discern relative contributions in each condition.

详细描述

The human brain has constant access to a multitude of complex signals, which it must simplify and organize in order to sustain the integrity of the organism. Many of these signals originate from outside of the body, such as lights, sounds, and smells, and much is known about how humans consciously perceive these 'exteroceptive' signals and how the human brain represents them. Comparatively little is known about how the human brain processes 'interoceptive' signals originating from inside of the body, despite the fact that the brain has access to far more of them (for instance, intestinal tension, bladder distension, breath, heartbeat, body temperature, blood pressure, serum osmolality, inflammation, proprioception etc.).

The current study study therefore aims to identify the brain regions responsible for encoding cardiorespiratory 'interoceptive' sensations and determine whether they are dysfunctional in individuals affected by eating disorders, anxiety, depression, or brain injury. Participants in this study will receive stimulation of the cardiorespiratory channel of the interoceptive system using bolus intravenous infusions of isoproterenol, a peripherally acting medication similar to adrenaline, and saline. Stimulation will occur during functional magnetic resonance imaging (fMRI) as well as outside of the fMRI scanner. After the scan participants will consume a meal. By evaluating the same interoceptive sensations across different human illnesses, the investigators hope to provide convergent evidence resulting in identification of core underlying neural processes, and to discern relative contributions in each condition.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnostic and Statistical Manual 5 (DSM 5) criteria for anorexia nervosa and age 18 to 40, or generalized anxiety disorder, or panic disorder, or major depressive disorder, or brain injury caused either by herpes simplex encephalitis or Urbach-Wiethe disease.

排除标准

  • DSM 5 diagnosis with any of the following: Schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, antisocial personality disorder, active suicidal ideation with intent or plan
  • Current cardiac arrhythmia
  • Current respiratory disease
  • Seizure disorder
  • MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/ wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy.

研究组 & 干预措施

Anorexia nervosa

Experimental

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Isoproterenol (Drug)

Anorexia nervosa

Experimental

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Normal saline (Drug)

Generalized anxiety disorder

Experimental

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Isoproterenol (Drug)

Generalized anxiety disorder

Experimental

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Normal saline (Drug)

Panic disorder

Experimental

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Isoproterenol (Drug)

Panic disorder

Experimental

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Normal saline (Drug)

Major depressive disorder

Experimental

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Isoproterenol (Drug)

Major depressive disorder

Experimental

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Normal saline (Drug)

Brain injury

Experimental

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Isoproterenol (Drug)

Brain injury

Experimental

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Normal saline (Drug)

Healthy comparison

Active Comparator

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Isoproterenol (Drug)

Healthy comparison

Active Comparator

Intravenous bolus infusions of isoproterenol (up to 4 micrograms per infusion) and normal saline.

干预措施: Normal saline (Drug)

结局指标

主要结局

Change in cardiorespiratory sensation intensity

时间窗: Baseline

Visual analogue rating of intensity of heartbeat and breathing sensations (scale: 0 to 10) through study completion (e.g., the day of testing).

次要结局

  • Eating disorder severity (Eating Disorder Examination scale)(Baseline)
  • Major depressive disorder severity (Patient Health Questionnaire-9 scale)(Baseline)
  • Change in anxiety level(Baseline)
  • Generalized anxiety disorder severity (Generalized Anxiety Disorder 7 scale)(Baseline)
  • Panic disorder severity (Panic Disorder Severity scale)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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