Research of Brain White Matter Hyperintensity in Migraine Using a Cerebrovascular Reactivity Mapping Based on BOLD MRI
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- CVR association with WMH development
研究概览
简要总结
Brain white matter hyperintensities (WMHs) are prevalent in migraineurs, of which the mechanism is still unclear. The investigators aimed to test the spatial association between areas with reduced cerebrovascular reactivity (CVR) to hypercapnic stimuli and consequent development of WMHs.
详细描述
A whole-brain map of CVR will be created in patients with migraine and normal controls. Hypercapnic stimuli for CVR will be delivered by prospective end-tidal CO2 targeting device. Hemodynamic responses will be determined by BOLD signal changes using fMRI. WMHs will be determined by high-resolution 3D FLAIR imaging. Patients and controls will undergo serial MRIs with 1 year interval. Associations between areas of reduced CVR and consequent WMH development will be tested in both patients and controls.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Migraineurs(patients) :
- •age 18-50 years
- •migraine with or without aura as defined by the third edition of the International Classification of Headache Disorders (ICHD-3 beta)
- •migraine duration > 6 months
- •episodic migraine feature headache (< 15 attacks/m)
- •not any preventive medications for migraine
- •age 18-50 years
- •no headache disorder requiring painkillers within the past year
- •no more than moderate intensity of headache within the past year
- •no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta
- •Exclusion criteria:
- •chronic migraine within last month (≥15 attacks/m)
- •medication overuse headache as defined by ICHD-3 beta
- •other comorbid disease that may affect vascular function (Hypertension, diabetes, hyperlipidemia, cerebral infarction, smoking etc)
- •can not breath 20 L for 1 minute because of basal cardiopulmonary disease (chronic obstructive pulmonary disease, heart failure etc)
- •a disease that can be exacerbated by elevated PCO2 in blood (Interstitial lung disease, amyotrophic lateral sclerosis etc)
- •predicted to be unable to write the headache diary due to cognitive decline
- •contraindications to MRI
- •pregnancy
- •refusal to informed consent
排除标准
- 未提供
结局指标
主要结局
CVR association with WMH development
时间窗: 1-year follow-up (2nd year)
The investigators will obtain a CVR map using BOLD MR signal in the first year of study and also obtain changes in WMH during 2 years of follow-up period in patients and controls, respectively. Then the investigators will test whether CVR-map predicts consequent WMH development in patients and controls, respectively.
次要结局
- Spatial pattern of CVR(baseline(1st year))
研究者
Chin-Sang Chung
MD, PhD, Professor of neurology
Samsung Medical Center