Investigation of Serotonin Receptor Binding in the Migraine Brain Using Positron Emission Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Differences in binding of the 5-HT4 radioligand
研究概览
简要总结
Migraine affects 16% of the world population and is one of the most disabling of all disorders. It is a complex brain disorder characterized primarily by recurrent headache attacks. The signaling molecule serotonin (5-hydroxytryptamine, 5-HT) has for decades been thought to play a central role in migraine pathophysiology. The most effective class of abortive migraine drugs, the triptans, act on 5-HT receptors. However, the migraine-specific actions of serotonin and the mechanisms of triptans are still unknown. In this project the investigators will use high-resolution positron emission tomography and specific radioligands to investigate the significance of serotonin in migraine. Two newly developed radioligands that are specific for the 5-HT1B and 5-HT4 receptor, respectively, will be applied. To investigate the level and distribution of serotonin in the migraine brain the investigators will compare the binding of these ligands in episodic migraine patients with healthy controls. In addition, the investigators will include chronic migraine patients to evaluate the relation between the level of serotonin in the brain and the frequency of migraine attacks. To investigate the changes in the serotonin level during a migraine attack and the effects of triptans on the central nervous system the investigators will repeat the scans using the 5-HT1B specific ligand during induced migraine attacks and following treatment with sumatriptan. The results from this study will shed light on the role of serotonin in the migraine brain and elucidate the migraine-specific action of triptans. This will improve our understanding of the migraine pathophysiology and, potentially, facilitate the development of more efficient treatment of migraine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- 是
入选标准
- 未提供
排除标准
- •Tension type headache more than 5 days per month during the last year.
- •Tension type headache on the experimental day.
- •Any other primary headache disorder
- •Migraine 48 hour before and after the experimental day (only episodic migraine patients)
- •Use of antimigraine medication or pain-killer on the experimental day before PET
- •Pregnant or breastfeeding women.
- •Contraindications against MRI.
- •History or clinical sign of cardio- or cerebrovascular disease.
- •Untreated severe mental disorder or drug abuse.
- •Other diseases or disorders interpreted, by the examining doctor, to interfere with participation in the study.
- •Not accepting information about potential accidental findings during the experiment.
结局指标
主要结局
Differences in binding of the 5-HT4 radioligand
时间窗: Up to 1 year
Differences in bindingpotentials for the 5-HT4 ligand between chronic migraine patients and healthy controls and between chronic and episodic migraine patients will be assessed using the Simplified Reference Tissue Model.
Differences in binding of the 5-HT1B radioligand
时间窗: Up to 1 year
Differences in binding between ictal and interictal binding and between ictal and post-treatment binding in episodic migraine patients will be assessed using the simplified reference tissue model
Correlation with migraine frequency and 5-HT4 receptor binding
时间窗: Up to 1 year
Correlations between migraine days and 5-HT4 receptor binding will be investigated using pooled data from episodic and chronic migraine patients on migraine frequency and their 5-HT4 receptor binding potentials assessed using the simplified reference tissue model
次要结局
未报告次要终点
研究者
Marie Deen Christensen
Medical Doctor
Danish Headache Center