NL-OMON47774已完成不适用
Brain and brainstem activation following duodenal nociceptive stimulation with capsaicin, an exploratory high-resolution fMRI study in healthy volunteers. - fMRI and visceral perception
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 26 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •* Of female sex;
- •* Based on medical history and previous examination, no gastrointestinal
- •complaints can be defined;
- •* Age between 18 and 65 years;
- •* BMI between 18 and 30 kg/m2;
- •* Women in fertile age (<55 years old) must use contraception or be
- •postmenopausal for at least two years;
- •* All subjects should be right-handed.
排除标准
- •* Presence of metallic prostheses, pacemakers, metal clips on blood vessels,
- •metal parts in the eye, an intrauterine device, metal braces, facial tattoos
- •(including permanent eye make-up) and/or other metal objects;
- •* History of major head trauma or head/brain surgery;
- •* History of claustrophobia;
- •* History of severe or chronic cardiovascular, respiratory, urogenital,
- •gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes,
- •nose, throat), dermatological/connective tissue, musculoskeletal,
- •metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy,
- •major surgery and/or laboratory assessments which might limit participation in
- •or completion of the study protocol;
- •* Use of medication, including vitamin and iron supplementation, except oral
- •contraceptives, within 14 days prior to start of the study;
- •* Major abdominal surgery interfering with gastrointestinal function
- •(uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and
- •other surgery upon judgment of the principle investigator);
- •* Pregnancy, lactation, wish to become pregnant;
- •* High alcohol consumption (>15 alcoholic consumptions per week);
- •* Using drugs of abuse;
- •* Self-admitted HIV-positive state;
- •* Known allergic reaction to capsaicin;
- •* High intake of spicy (capsaicin containing) food (meaning an estimated intake
- •of > than 1.5mg/day), due to possible desensitization of the capsaicin receptor
- •TRPV1 (see further below);
- •* Administration of investigational drugs or participation in any scientific
- •intervention study which may interfere with this study (to be decided by the
- •principle investigator), in the 180 days prior to the study;
- •* Any evidence of structural brain abnormalities examined by anatomical MRI
- •will lead to exclusion.
研究者
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