A Brain Imaging Study of the Analgesic Effect of Lidocaine and the Hyperalgesic Effect of Capsaicin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Subjective Response to Pain (0-20 Visual Analogue Scale)
研究概览
简要总结
This study will use using fMRI (functional Magnetic Resonance Imaging) to elucidate how contextual learning/expectation relieves or aggravates pain experience in the same cohort of subjects and the same study session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a) Healthy male and female adults aged 21-50
- •b) No contraindications to fMRI scanning
- •c) Right handed
排除标准
- •a) Current or past history of major medical, neurological, or psychiatric illness
- •b) Pregnancy or breast feeding, menopause, and irregular menstrual cycles (length of cycle must be within 26 to 32 days)
- •c) Claustrophobia
- •d) History of head trauma
- •e) History of impaired elimination
- •f) Instability of responses to experimental pain (see Study Procedures Section)
- •g) Use of psychotropic drugs, hormone treatments (including hormonal birth control) within 1 year
- •h) Non-fluent speaker of English
研究组 & 干预措施
Arm 1
There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.
干预措施: Heat pain applied using TSA or CHEPS (Device)
结局指标
主要结局
Subjective Response to Pain (0-20 Visual Analogue Scale)
时间窗: Weeks 1-3
Subjects received heat pain before and after the application of a neutral cream (told one application of neutral cream was lidocaine, one was capsaicin, and one was neutral) and rated pain intensity on a 0-20 Visual Analogue Scale (0-no pain, 20-intolerable pain). We only measure this outcome measure in session 3. The pain intensity for each cream was averaged amongst all participants for both the pre and post treatment in session 3. Subjects have up to 3 weeks to complete the 3 sessions.
fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex
时间窗: Week 4
We used fMRI to investigate the signal changes associated with administration of identical pain stimuli before (pre) and after the treatment (post) with different creams in session 3. It is important to note that the subjects had multiple weeks to complete the study, but this measure was only taken during one session. The change was calculated from two time points as the value at the later time point (post treatment) minus the value at the earlier time point (pre treatment).
次要结局
未报告次要终点
研究者
Jian Kong
Assistant Professor
Massachusetts General Hospital