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临床试验/NCT03999060
NCT03999060已完成不适用

Brainstem Mapping of Nociceptive Trigeminal Input

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年6月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Statistical Parametric Map calculated from the fMRI data in the insula

研究概览

简要总结

To what extent the somatotopy of the 3 branches of the trigeminal nerve (V1,V2,V3) as well as the greater occipital nerve (GON) in the brainstem but also in the thalamus and the insula can be mapped using functional imaging and BOLD in humans is not known but might play an important role in imaging headache diseases. The aim is to map their somatotopy by random stimulation of V1, V2, V3 and the GON with painful electrical input during acquisition of BOLD-fMRI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suitable fo MRI

排除标准

  • headache disease
  • psychological disorder
  • pregnancy
  • all exclusion criteria necessary for imaging in a 3 T MRI scanner

研究组 & 干预措施

Electric Stimulation

Experimental

干预措施: Electric Current Stimulation (Device)

结局指标

主要结局

Statistical Parametric Map calculated from the fMRI data in the insula

时间窗: through study completion, an average of 9 months

At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the insula: Expected location for V1: within radius of 10 mm around the MNI coordinates (38,-15,8); Expected location for V2: within radius of 10 mm around the MNI coordinates (37,-8,-5) Expected location for V3: within radius of 10 mm around the MNI coordinates (39,2,-11) Expected location for GON: within radius of 10 mm around the MNI coordinates (38,-12,-3)

Statistical Parametric Map calculated from the fMRI data in the thalamus

时间窗: through study completion, an average of 9 months

At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the thalamus: Expected location for V1: within radius of 10 mm around the MNI coordinates (11,-5,6); Expected location for V2: within radius of 10 mm around the MNI coordinates (13,-11,5) Expected location for V3: within radius of 10 mm around the MNI coordinates (12,-10,5) Expected location for GON: within radius of 10 mm around the MNI coordinates (15,-12,-7)

Statistical Parametric Map calculated from the fMRI data on brainstem level

时间窗: through study completion, an average of 9 months

At a statistical threshold of T-value 3 we will observe a somatotopical arrangement in the brainstem below the pons: Expected location for V1: within radius of 10 mm around the MNI coordinates (-1,-48,-75); Expected location for V2: within radius of 10 mm around the MNI coordinates (-4,-47,-69) Expected location for V3: within radius of 10 mm around the MNI coordinates (-1,-46,-66) Expected location for GON: within radius of 10 mm around the MNI coordinates (-1,-45,-64)

次要结局

  • Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG)(through study completion, an average of 9 months)
  • Statistical Parametric Map calculated from the fMRI data in the cerebellum(through study completion, an average of 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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