Investigation of Functional Brain Features in Women with Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Brain excitability in migraine patients
研究概览
简要总结
This study aims to investigate whether the functional alterations in the brain of individuals with migraine appear before the peripheral vascular changes. This will be investigated using functional and structural neuroimaging in individuals with spontaneous menstually-related migraine.
详细描述
Spontaneous migraine attacks are unpredictable and therefore been logistically arduous to investigate in neuroimaging studies. Menstrually-related migraine provides an opportunity to study spontaneous attacks in a controlled imaging setup. The present project aims to investigate women with menstrually-related migraine using daily functional magnetic resonance imaging (MRI) scans 2-3 days before the onset of the menstrual bleeding and until (and including) the headache phase of migraine or up to five consecutive days. A control-group of women without migraine will also be recruited and undergo the same MRI scan protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For women with migraine
- •Episodic menstrually-related migraine without aura > 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria
- •For women with migraine and healthy women
- •18-40 years of age
- •Weight 50-100 kg
- •Regular menstruation
排除标准
- •For women with migraine
- •Other primary headache disorders than migraine, except infrequent episodic tension-type headache according to the ICHD-3 criteria
- •Secondary headache disorders
- •Headache on the first scan day or 48 hours before the first scan
- •Absence of the menstruation for the past 12 months
- •Daily intake of medication of any kind except oral contraceptives
- •Ingestion of any type of medication later than 4 times the plasma half-life of the substance in question (on the day of the scan), except for oral contraceptives
- •Intake of coffee, tea or alcohol 12 hours prior to scan days
- •Fertile women not using safe contraception. Fertile women are defined as women without hysterectomy and < 2 years postmenopausal women. Safe contraception includes the intrauterine device, oral contraceptive pills, surgical sterilization of the woman, depot progestogen or condoms
- •Change of hormonal contraceptives for the past 3 months
- •Perimenstrual syndrome
- •Pregnant or breastfeeding women
- •Information or clinical signs of:
- •Hypertension (systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg)
- •Low blood pressure (systolic blood pressure < 100 mm Hg and/or diastolic blood pressure < 50 mm Hg)
- •Cardiovascular diseases of any kind, including cerebrovascular disease
- •Unregulated mental illness or substance abuse
- •Illnesses of any kind deemed incompatible by the examining physician for participation in the study
- •Contraindications to MRI (including metal in the body or claustrophobia)
- •Do not want to be informed about unexpected pathological findings on the MRI
- •For healthy women
- •History of any primary headache except infrequent episodic tension-type headache according to the ICHD-3 criteria
- •First degree family history of primary headache disorders except infrequent episodic tension-type headache according to the ICHD-3 criteria (max five days/month)
- •Secondary headache disorders
- •Headache during the menstrual period from 2 days before to 2 days after the first menstrual bleeding day
- •Headache on the first scan day or 48 hours before the first scan
- •Absence of the menstruation for the past 12 months
- •Daily intake of medication of any kind except oral contraceptives
- •Ingestion of any type of medication later than 4 times the plasma half-life of the substance in question (on the day of the scan), except for oral contraceptives
- •Intake of coffee, tea or alcohol 12 hours prior to scan days
- •Fertile women not using safe contraception. Fertile women are defined as women without hysterectomy and < 2 years postmenopausal women. Safe contraception includes the intrauterine device, oral contraceptive pills, surgical sterilization of the woman, depot progestogen or condoms
- •Change of hormonal contraceptives for the past 3 months
- •Pregnant or breastfeeding women
- •Perimenstrual syndrome
- •Information or clinical signs of:
- •Hypertension (systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg)
- •Low blood pressure (systolic blood pressure <100 mm Hg and/or diastolic blood pressure < 50 mm Hg) Investigation of functional brain features in women with migraine
- •Cardiovascular diseases of any kind, including cerebrovascular disease.
- •Unregulated mental illness or substance abuse
- •Illnesses of any kind deemed incompatible by the examining physician for participation in the study
- •Contraindications to MRI (including metal in the body or claustrophobia)
- •Do not want to be informed about unexpected pathological findings on the MRI
结局指标
主要结局
Brain excitability in migraine patients
时间窗: Up to 5 days in relation to menstruation
Changes in the migraine brain excitability in areas related to migraine during the menstrual period. This will be assessed functional magnetic resonance imaging.
Brain connectivity in migraine patients
时间窗: Up to 5 days in relation to menstruation
Changes in the migraine brain connectivity in areas related to migraine during the menstrual period. This will be assessed functional magnetic resonance imaging.
Arterial circumference in migraine patients
时间窗: Up to 5 days in relation to menstruation
Changes in arterial circumference during the menstrual period. This will assessed using Magnetic Resonance Angiography.
Arterial circumference after rescue medication in migraine patients
时间窗: Up to 5 days in relation to menstruation
Changes in arterial circumference after rescue medication in migraine patients. This will assessed using Magnetic Resonance Angiography.
Brain excitability in healthy volunteers
时间窗: Up to 5 days in relation to menstruation
Changes in brain excitability or connectivity in areas related to migraine during the menstrual period in healthy volunteers. This will be assessed using functional magnetic resonance imaging.
Brain connectivity in healthy volunteers
时间窗: Up to 5 days in relation to menstruation
Changes in brain connectivity in areas related to migraine during the menstrual period in healthy volunteers. This will be assessed using functional magnetic resonance imaging.
Arterial circumference in healthy volunteers
时间窗: Up to 5 days in relation to menstruation
Changes in arterial circumference during the menstrual period in healthy volunteers. This will assessed using Magnetic Resonance Angiography.
次要结局
- Migraine attacks during the menstrual period(Up to 7 days in relation to menstruation)
- Association of the migraine attack features to brain excitability(Up to 5 days in relation to menstruation)
- Association of the migraine attack features to functional connectivity(Up to 5 days in relation to menstruation)
- Association of the migraine attack features to vasculature changes(Up to 5 days in relation to menstruation)
研究者
Faisal Mohammad Amin
Principal Investigator
Danish Headache Center