NCT04174651已完成不适用
The Cerebral Mechanism of Stress-Induced Spontaneous Scratching in Healthy Volunteers and Patients With Atopic Dermatitis (AD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Changes in brain activity
研究概览
简要总结
The purpose of this study is to examine scratching behavior and identify brain areas responsible for stress-induced spontaneous scratching in patients with atopic dermatitis (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects and AD patients between 18 and 59 years of age.
- •Healthy subjects: In general, good health without history of neurological and psychiatric diseases.
- •AD patients: An average itch rating of 3 out of 10 or greater in the past two weeks using a Numerical Rating Scale (NRS).
- •All patients will be required to cease use of oral antihistamines from the night before each study visit until the end of the experiment. The purpose is to avoid that participants fall asleep during MRI measurement due to side effect oral antihistamine (i.e., sedation).
- •Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant.
- •MRI Compatibility, criteria include having no major contraindication for MRI (pacemaker, vascular stents, metallic ear tubes, and absence of metal implants or braces) as assessed by MRI technologist using site approved screening form.
- •Participants have to be able to speak and read English fluently.
- •Participants must have signed a written informed consent before being enrolled in the study
排除标准
- •Individuals under 18 or over 59 years of age.
- •Inability to complete the required measures.
- •Suffering from any disease state or physical condition, which would increase their health risk by study participation.
- •Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
- •Recent initiation (within last 3 months) of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications.
- •Patients who use centrally acting agents only when they need. The purpose is to avoid a risk of acute effect of these agents on brain activity and perceived stress due to the stress task.
- •Current treatment with opioid analgesics.
- •Uncontrolled thyroid disease.
- •Use of illicit drugs or history of opiate addiction.
- •Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active right now.
- •Any known diseases or disorders that may affect conducting the experiments (e.g., intracranial pathology, claustrophobia, severe respiratory or cardiovascular problems, active fibromyalgia) or diseases that have potential risks of infections (e.g., HIV, Hepatitis C, etc).
- •Inability to speak and read English.
- •Being pregnant.
- •Incarcerated.
结局指标
主要结局
Changes in brain activity
时间窗: Baseline, 15 minutes
Changes in brain activity will be measured as change in Arterial spin Labeling (ASL) which reflects regional cerebral blood flow. This will be evaluated using functioning magnetic resonance imaging (fMRI).
Change in time of spontaneous scratching
时间窗: Baseline, 15 minutes
Change in spontaneous scratching for behavioral only arms will be calculated by subtracting total duration of scratching behavior before and after the TSST and Landscape video.
次要结局
- Correlation of perceived stress with stress-induced brain activity(60 minutes)
研究者
Hideki Mochizuki
Assistant Professor
University of Miami
研究点 (2)
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