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临床试验/NCT02424318
NCT02424318已完成4 期

Effect of Topiramate on Cerebrovascular Response to Photic Stimulation in Migraineurs

SMG-SNU Boramae Medical Center0 个研究点目标入组 19 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
19
主要终点
Comparison of the Cerebrovascular reactivity

研究概览

简要总结

The purpose of this study is to evaluate the effect of topiramate on cerebrovascular reactivity and mean flow velocity to photic stimulation in migraineurs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • aged 18 to 65 years
  • newly-diagnosed patients with migraine without aura (International Headache Society classification)
  • symptom frequency (at least 2 episodes of migraine attack/month)

排除标准

  • prior use of preventive medication
  • patients with cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, smoking)
  • patients who take antihypertensive agent or antidepressant
  • patients who were pregnant, breast-feeding or actively smoking
  • patients with neurological or cerebrovascular diseases

研究组 & 干预措施

Topiramate

Experimental

topiramate 25mg twice for 1 week -> topiramate 50mg twice for 7 weeks

干预措施: Topiramate (Drug)

结局指标

主要结局

Comparison of the Cerebrovascular reactivity

时间窗: between baseline and after 2-month treatment of topiramate

Transcranial Doppler sonography (TCD) was performed twice in migraineurs before and after the topiramate treatment during their interictal period of headache. Measurements: the mean flow velocity (MFV) of the right middle cerebral artery (MCA) and the left posterior cerebral artery (PCA). After 1 minute of adaptation period to the darkness, flashlights of 10 Hz were presented using a light source of an electroencephalography machine (PS40/R-220, Grass Technologies, West Warwick, USA). Recordings were performed for 10 cycles, and each cycle consisted of 10-second stimulation-on and 10-second stimulation-off. Calculation: Cerebrovascular reactivity (CVR) CVR = Δ V/Vb or Δ V/(VbxΔT) Where Vb is the baseline MFV, Δ V/Vb is the percentage MFV increase (amplitude), ΔT is the time from the onset of the stimulation to the peak MFV, and Δ V/(VbxΔT) is the slope of the MFV increase.

次要结局

  • Comparison of the mean flow velocities in the middle and posterior cerebral artery(between baseline and after 2-month treatment of topiramate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyunwoo Nam

SMG-SNU Boramae Medical Center

SMG-SNU Boramae Medical Center

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