The Representation of the Sensibility of the Breast on the Somatosensory Cortex
The Representation of the Sensibility of the Breast on the Somatosensory Cortex Using 7 Tesla fMRI: A Pilot Study
Rationale: The representation of the breast on the somatosensory cortex has not been precisely located. Therefore, a pilot study with healthy subjects is needed to localize the sensibility of the breast on the somatosensory cortex with the use of a 7 Tesla fMRI.
Objective: To determine the exact localization of the representation of the sensibility of the breast and nipple-areola complex on the somatosensory cortex. Secondly, to assess whether there are differences in representation between individuals of the same sex and between both sexes.
Study design: A single center pilot study carried out in the Maastricht University Medical Center, the Netherlands.
Study population: A total of 10 female and 10 male healthy individuals will be recruited.
Intervention: Every subject will undergo a functional MRI scan with stimulators applied to the bare breast in a fixed pattern. These stimulate the skin and sensory nerves of the breast and nipple-areola complex in a random sequence.
Main study parameters: The hemodynamic response after stimulation of the skin of the breast and nipple-areola complex, representing neuronal activity in that region, is measured. Within the somatosensory cortex (S1 and S2), the temporo-spatial brain activity patterns after the various stimulation conditions are assessed, and the representation of the breast on the somatosensory cortex is mapped.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Limburg
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Maastricht、Limburg、荷兰、6229 HX
- Maastricht University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Man or woman
- Between 21 and 35 years old
- Healthy; i.e. no comorbidities
- Women: breast size cup B or C
- BMI < 27.0 kg/m2
- Informed consent
Exclusion Criteria:
- Any comorbidities
- Previous breast operation of any kind
- Previous allergic reactions to adhesives or plasters
- Any MRI exclusion criteria e.g.:
(No piercings or other iron materials (except a metal brace behind front teeth) (Claustrophobia)
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Females
Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.
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7.0 Tesla functional MRI scan
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实验性的:Males
Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.
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7.0 Tesla functional MRI scan
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex
大体时间:90 minutes
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Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex.
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90 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex in males compared to females
大体时间:90 minutes
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Differences between both sexes in localization or representation of the breast in the somatosensory cortex will be assessed.
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90 minutes
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Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex between individuals of the same sex
大体时间:90 minutes
|
Differences between individuals of the same sex in localization or representation of the breast in the somatosensory cortex will be assessed.
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90 minutes
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合作者和调查者
调查人员
- 首席研究员:Rene van der Hulst, prof,MD,PhD、Maastricht University Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- NL54890.068.15
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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