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临床试验/NCT04810234
NCT04810234Unknown不适用

Functional Neural Correlates of Transcutaneous Vagal Nerve Stimulation: Effects of Anatomical Site and Waveform Parameters - An Exploratory High Resolution fMRI Study in Healthy Volunteers

Maastricht University Medical Center2 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
16
试验地点
2
主要终点
Blood oxygenation level dependent (BOLD) signal activity in the CAN during tVNS

研究概览

简要总结

Transcutaneous vagal nerve stimulation (tVNS) has been applied to a number of disease areas including visceral pain, depression, cluster headache and Alzheimer's disease. However, there is marked heterogeneity in these studies pertaining to i) the anatomical site of stimulation (neck, inner concha or tragus of ear), and ii) the waveform parameters of the stimulating impulse. This exploratory cross-sectional study will address these knowledge gaps by comparative functional neuroimaging of the neural correlates of tVNS with disparate anatomical sites and electrical waveform characteristics during rest in healthy participants.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Blood oxygenation level dependent (BOLD) signal activity in the CAN during tVNS

时间窗: During stimulation (difference between stim on - stim off blocks)

fMRI related outcome measure

次要结局

  • Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during auricular tVNS (parameter set 1)(During stimulation (difference between stim on - stim off blocks))
  • Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during subliminal auricular tVNS (parameter set 1)(During stimulation (difference between stim on - stim off blocks))
  • Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during cervical tVNS )(parameter set 1)(During stimulation (difference between stim on - stim off blocks))
  • Functional connectivity / Network Connectivity of CAN regions during "active tVNS" block [to all 5 points as identified above](During stimulation (difference between stim on - stim off blocks))
  • Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during auricular tVNS (parameter set 2)(During stimulation (difference between stim on - stim off blocks))
  • Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during cervical tVNS (parameter set 2)(During stimulation (difference between stim on - stim off blocks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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