Glutamate Concentrations in the Brain Over the Course of a Migraine-like Attack
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- Glutamate
研究概览
简要总结
To investigate the glutaminergic system in the onset of migraine-like attacks.
详细描述
Glyceryl trinitrate infusion (GTN) is used to provoke migraine-like attacks in female migraine without aura patients. Apart from migraine without aura patients healthy female controls are also included as a control group. Over the course of a single day these females (migraineurs and healthy controls) were scanned three times on fixed time slots: before GTN infusion (baseline), 90 minutes and 270 minutes after start of GTN infusion. Scans are acquired on a 7 tesla scanner (Philips, Cleveland, USA) on software release 3 using a 32 channel receive array using single-volume proton magnetic resonance spectroscopy (1H MRS) with a volume of interest in the visual cortex glutamate, in which glutamate, GABA and other metabolites will be assessed. The primary endpoint; glutamate level changes towards the pre-ictal and ictal state with other metabolite (e.g. glutamine and GABA) changes as secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with migraine without aura according to the International Classification of Headache Disorders (ICHD)-3 beta criteria from
- •At least one migraine attack per month in the preceding six months
排除标准
- •Other neurological disorders apart from migraine
- •Chronic medication apart from oral contraceptives
- •Migraine with aura
- •Chronic migraine with 15 or more headache days per month/with 8 or more migraine days per month
- •Medication-overuse headache (ICHD-3 beta criteria)
- •Women who are breastfeeding, pregnant, or planning to become pregnant
- •Contra-indications for 7 tesla MRI scanner
- •Contra-indications for GTN administration (e.g. nitrate allergy, heart condition)
- •Healthy controls (with no first degree relative with migraine or trigeminal autonomic cephalalgia)
研究组 & 干预措施
Migraine without aura subjects
Drug: Glyceryl trinitrate (GTN)
干预措施: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min) (Drug)
Healthy subjects
Drug: Glyceryl trinitrate (GTN)
干预措施: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min) (Drug)
结局指标
主要结局
Glutamate
时间窗: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Changes in glutamate level
次要结局
- Myo-inositol(From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state)
- Glutathione(From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state)
- Aspartate(From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state)
- Creatine(From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state)
- Choline(From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state)
- Glutamine(From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state)
- GABA(From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state)
- N-acetylaspartate(From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state)
- Phosphoethanolamine(From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state)
研究者
G.M. Terwindt, MD
Associate professor
Leiden University Medical Center