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临床试验/NCT04032639
NCT04032639招募中不适用

Chronic Stress, Cognition, and Food Cue Reactivity in Prader-Willi Syndrome: A Magnetoencephalography Study

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Neuronal activity during the food cue reactivity task

研究概览

简要总结

Individuals with Prader-Willi Syndrome (PWS) have increased hunger and food seeking behaviour, as well as learning (cognitive) challenges. In addition, some patients with PW been shown to have low cortisol production, particularly in stressful situations. However, research examining how hormonal, cognitive, and psychological factors are interrelated PWS is limited. To address this gap in knowledge, the goal of this project is to understand how changes in brain regions involved in controlling food intake and cognitive processes are related to changes in hormones regulating appetite, the stress hormone cortisol, and performance on neuropsychological tests.

详细描述

Prader-Willi Syndrome (PWS) is characterized by hyperphagia, although the degree of food seeking can vary between individuals. This behaviour may be moderated by hormonal, neurocognitive, and psychological factors; however, data assessing these factors in an integrated fashion is scarce. The proposed research will address and identify relationships between three major challenges in PWS: 1) dysregulated feeding behaviour, 2) cognitive performance, and 3) chronic stress. The investigators will measure brain response to food cues, during a cognitive task, and at rest using magnetoencephalography (MEG) in adolescents with PWS and BMI-matched controls. This is an innovative design as previous studies in this population used only functional magnetic resonance imaging (fMRI) to examine food cue reactivity, which does not directly measure neuronal activity and lacks temporal-sensitivity. In contrast, MEG directly records neural firing and combines high spatial resolution with exquisite temporal resolution, allowing us to measure functional connectivity between brain regions. Importantly, MEG is also patient-friendly with fewer contraindications than MRI. To assess cognitive function, the investigators will utilize gold-standard neuropsychological measures, as well as emotional and social behavioural functioning. Lastly, the investigators will assess hair cortisol, which is a reflection of long term, month-by-month cortical exposure. This new area of research will explore neurobiological and cognitive mechanisms controlling feeding behaviour in PWS.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Genetically diagnosed PWS (study population)
  • Adolescents matched for age, sex, and BMI-percentile (controls)

排除标准

  • Past or current history of alcoholism or consistent drug use
  • Current untreated major psychiatric illness as defined by the DSM-V criteria
  • Medications that decrease alertness (that cannot be held on the days of testing)
  • History of recent major head trauma
  • Current pregnancy
  • Diagnosis of diabetes
  • Current or recent smoker (i.e. >2 cigarettes/week during past year)
  • History of metal in body (shrapnel, metal slivers, unremovable metal adornments, clips, top braces, pacemaker)
  • Use of glucocorticoid medications

结局指标

主要结局

Neuronal activity during the food cue reactivity task

时间窗: 2 years

To compare neuronal activity between PWS and controls during the food cue task

次要结局

  • Relationships between appetite hormone response and neuronal activity during the food cue task(2 years)
  • Relationships between cortisol and neuronal activity during the food cue reactivity task(2 years)
  • Neuronal activity during the emotional processing task(2 years)
  • Neuronal activity during resting state(2 years)
  • Neuronal activity during the response inhibition task(2 years)
  • Relationships between neuropsychological function and neuronal activity during the emotional processing task(2 years)
  • Relationships between cortisol and neuronal activity during the emotional processing task(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill Hamilton

Principal Investigator

The Hospital for Sick Children

研究点 (1)

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