Neuromodulation of Placebo and Nocebo Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
tDCS Enhancement
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
干预措施: transcranial direct current stimulation (tDCS) (Device)
tDCS Enhancement
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
干预措施: Capsaicin cream (Other)
tDCS Enhancement
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
干预措施: Control cream (Other)
tDCS Inhibition
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
干预措施: transcranial direct current stimulation (tDCS) (Device)
tDCS Inhibition
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
干预措施: Capsaicin cream (Other)
tDCS Inhibition
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
干预措施: Control cream (Other)
Sham tDCS
Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons.
干预措施: transcranial direct current stimulation (tDCS) (Device)
Sham tDCS
Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons.
干预措施: Capsaicin cream (Other)
Sham tDCS
Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons.
干预措施: Control cream (Other)
Sham tDCS
Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons.
干预措施: Lidocaine cream (Other)
tDCS Inhibition
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
干预措施: Lidocaine cream (Other)
tDCS Enhancement
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
干预措施: Lidocaine cream (Other)
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
Jian Kong
Associate Professor
Massachusetts General Hospital