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临床试验/NCT03152305
NCT03152305Unknown不适用

Measure of Intracranial Pressure Variations During Migraine Attacks

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年7月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Intracranial pressure variations

研究概览

简要总结

An increase in intracranial pressure (ICP) during migraine attacks is possible and could contribute to pain initiation and maintenance. From now on, it was not possible to measure ICP in a non-invasive way. The development of a new tool allows non-invasive self-measures of ICP variations. Thus, it is possible for the first time to look for such ICP variations during migraine attacks and to conclude if this mechanism is implied in the pathophysiology of migraine.

详细描述

Womens presenting with regular menstrual migraine treated with triptans will be included in the study. Self-measure of ICP will be performed outside and during menstrual migraine attacks. The potential variations will be compared to the measures done on matched healthy women outside and during menses.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 to 50 non menopausal women
  • Menstrual migraine
  • Using a triptan as usual treatment to relieve attacks
  • Usual triptan efficacy although recurrence is possible

排除标准

  • Disease of the ear
  • Intracranial hypertension
  • Chronic daily headache
  • Use of topiramate or acetazolamide
  • Triptans used more than 10 days/month
  • Analgesic drug used more than 15 days/month
  • Uncontrolled high blood pressure
  • Ongoing allergic rhinitis or flu

结局指标

主要结局

Intracranial pressure variations

时间窗: during menstrual migraine attacks

Measured during menstrual migraine attacks compared to ICP in non-migraine days and in matched healthy women

次要结局

  • Relationships between ICP variations and clinical parameters(during menstrual migraine attacks)
  • Relationships between ICP variations and pain relief(during menstrual migraine attacks)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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