The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Intra-extra cerebral arteries vasodilatation
研究概览
简要总结
Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38) induced headache effects on extra- and intracerebral arteries and pre-posttreated by sumatriptan and ketorolac assessed by magnetic resonance imaging (MRI) on healthy volunteers.
详细描述
The purpose of this research project is to investigate the importance of blood vessel (vasodilatation), vessel wall inflammation and blood flow in arteries of headaches triggered by PACAP38 and for headache treated with sumatriptan (migraine medicine) and ketorolac (NSAID). In addition, we will investigate headache-related changes in the brain's network connectivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy volunteers
- •Aged 18-50
- •50-100 kg
排除标准
- •Tension type headache more than 5 dag /month
- •Other primary headaches
- •Daily medication except contraceptives
- •Drug taken within 4 times the half-life for the specific drug except contraceptives
- •Pregnant or lactating women
- •Exposure to radiation within the last year
- •Headache within the last 24 hours before start of trial
- •Hypertension
- •Hypotension
- •Respiratory or cardiac disease
- •Primary relatives with current or previous migraine
结局指标
主要结局
Intra-extra cerebral arteries vasodilatation
时间窗: 120 minutes
PACAP38 vasodilatation reverse by sumatriptan but not ketorolac. A single-slab 3D time-of-flight (3D TOF) MRA of extra- and intracranial arteries will be acquired as described in previous studies (Amin et al., 2013, 2014). MRA data will be analyzed by LKEB-MRA vessel wall analysis software program. We will measure the circumference of vessels in millimeter in 4 predefined time points (0, 20, 60 and 110 min)
Headache score
时间窗: 6 hours
Visual analog Scale
次要结局
- Headache characteristics(24 hours)
- Blood pressure(2 hours)
- Heart rate(2 hours)
研究者
Hashmat Ghanizada
Principal investigator
Danish Headache Center