NL-OMON56195招募中不适用
The effect of Transcutaneous Vagal Nerve Stimulation on the processing of visceral pain signals: a High Resolution fMRI Study in Healthy Volunteers - Effects of tVNS on visceral pain
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Of female sex;
- •Healthy participants (defined as those without a pre-existing medical
- •comorbidity)
- •Age between 18 and 40 years;
- •BMI between 18 and 30 kg/m2;
- •All subjects should use some form of contraception (for IUDs only Mirena is
- •All subjects should be right-handed.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •Presence of metallic prostheses, pacemakers, metal clips on blood vessels,
- •metal parts in the eye, an intrauterine device (with the exception of the
- •Mirena IUD), metal braces, tattoos 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, haematological/immunologic, HEENT (head, ears, eyes,
- •nose, throat), dermatological/connective tissue, musculoskeletal,
- •metabolic/nutritional, endocrine, neurological/psychiatric diseases, major
- •surgery and/or laboratory assessments which might limit participation in or
- •completion of the study protocol;
- •Use of regular medication, including vitamin and iron supplementation, except
- •oral contraceptives, within 14 days prior to start of the study;
- •Pregnancy, lactation, wish to become pregnant;
- •High alcohol consumption (>15 alcoholic units consumed per week);
- •Using drugs of abuse;
- •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;
- •Participants unable to provide informed consent
- •Participants with any systemic disease or medications that may influence the
- •autonomic nervous system (e.g. beta-agonists or Parkinson*s disease)
- •Current smokers or current use of nicotine in any other way (including
- •E-cigarettes and patches)
- •History of clinical anxiety or depression, or a hospital anxiety or
- •depression score >8
- •Participants whom score 8 or more on the HADS-questionnaire at study
- •commencement
- •Patient whom have cardiovascular conduction problems
- •Patient with cochlear implants
- •Not meeting any of the inclusion criteria above
- •Any evidence of structural brain abnormalities examined by anatomical MRI
- •will lead to exclusion
研究者
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