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临床试验/NCT03102710
NCT03102710已完成不适用

Neuromodulation of Placebo and Nocebo Effects

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
2
主要终点
fMRI Resting States Functional Connectivity Changes During Pain Stimulation

研究概览

简要总结

The aim of this study is to use a brain stimulation tool called transcranial direct current stimulation (tDCS) to investigate the analgesic (reducing sensitivity to pain) effects of lidocaine cream and the hyperalgesic (increasing sensitivity to pain) effects of capsaicin cream using a neutral cream as a control. tDCS stimulation has been shown to temporarily influence the way the stimulated part of the brain functions. With this method, the involvement of specific parts of the brain can be investigated in the working of the brain as a whole.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Right handed healthy male and female adults aged 21-50
  • No contraindications to fMRI scanning
  • At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

排除标准

  • Current or past history of major medical, neurological, or psychiatric illness
  • Claustrophobia
  • History of head trauma
  • Instability of responses to experimental pain
  • Non-fluent speaker of English
  • Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy
  • History of alcohol/substance abuse

结局指标

主要结局

fMRI Resting States Functional Connectivity Changes During Pain Stimulation

时间窗: up to 2 weeks

We measured changes in blood oxygen level-dependent (BOLD) activity in the brain during pain stimulation. In the outcome measure data table, "placebo contrast" indicates lidocaine - neutral and "nocebo contrast" indicates capsaicin - neutral.

Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation

时间窗: up to 2 weeks

We investigated the effects of cathodal (inhibition) and anodal (enhancement) tDCS on rDLPFC functional connectivity (FC) with the supplementary motor area (SMA) and anterior insula. Higher Fisher Z-scores represent greater resting-state functional connectivity.

次要结局

  • Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS(up to 2 weeks)

研究者

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

Jian Kong

Associate Professor

Massachusetts General Hospital

研究点 (2)

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