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临床试验/NCT04019496
NCT04019496已完成不适用

Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine

University Medicine Greifswald1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年1月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
nociceptive blink reflex habituation

研究概览

简要总结

This study aims to improve the pathophysiological understanding of migraine in in a longitudinal observational study investigating changes of established neurophysiological and imaging parameters in line with changes of the clinical phenotype.

The study's focus is the investigation of mechanisms that are directly related to the cyclic character of migraine and its core structures. In this context, the primary endpoint is a change in the nociceptive blink reflex, an established brain stem reflex to study the trigemino-spinal system, associated with changes in migraine frequency and severity. In order to reliably detect changes in the trigeminal pain system, investigations are performed in patients before starting a prophylactic therapy and 3 months afterwards. Several secondary endpoints are used to evaluate changes of multimodal sensory and cortical information processing. Cerebral imaging will include examinations of structural and network effects of altered migraine disease activity.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Episodic Migraine

干预措施: antibodies against calcitonin-gene related peptide or its receptor (Drug)

结局指标

主要结局

nociceptive blink reflex habituation

时间窗: baseline and after 3 months

habituation of the area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches

次要结局

  • nociceptive blink reflex area(baseline and after 3 months)
  • somatosensory evoked potentials (SSEP)(baseline and after 3 months)
  • pattern-reversal visual evoked potentials (VEP)(baseline and after 3 months)
  • migraine headache frequency(baseline and after 3 months)
  • headache impact test (HIT-6)(baseline and after 3 months)
  • migraine disability assessment (MIDAS)(baseline and after 3 months)
  • Patient-Reported Outcomes Measurement Information System Profile 29 (PROMIS-29)(baseline and after 3 months)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (1)

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Neurophysiology of Prophylactic Treatment in Migraine | 临床试验