Discovering the Functional Role of the Glymphatic System in the Genesis of the Migraine Attack
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline glymphatic function after nitroglycerin administration
研究概览
简要总结
This study aimed to investigate the role of the glymphatic system in the initiation of migraine attacks, using non-invasive magnetic resonance imaging techniques and a validated model of migraine induction by nitroglycerin administration. Secondarily, the relationship between the function of the glymphatic system during nitroglycerin-induced migraine attacks and sleep architecture and plasma levels of migraine-involved neuropeptides will be investigated.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients:
- •Diagnosis of migraine, by the ICHD-3 criteria;
- •For both patients and healthy controls:
- •Age between 18 and 60 years;
- •Willing and able to comply with scheduled visits.
- •Exclusion criteria
- •For patients:
- •Overuse of acute medications for headache;
- •Continuous or daily headache;
- •Other primary headache disorders, with the exception of infrequent tension-type headache.
- •For healthy controls:
- •Any subject with frequent tension type headache, migraine, cluster headache, other pain syndromes or neurological conditions.
- •For both patients and healthy controls:
- •Allergy to nitroglycerin;
- •Major psychiatric disorders such as bipolar affective disorder and schizophrenia;
- •Cardiovascular diseases that contraindicated the use of nitroglycerin;
- •Intracranial hypertension;
- •Cerebral haemorrhage;
- •Cerebral trauma;
- •Pulmonary toxic oedema;
- •Closed angle glaucoma;
- •Pregnancy and breastfeeding;
- •Aortic stenosis or significant hypotension (SBP<90mmHg or <100mmHg and symptomatic) precluding nitroglycerin administration;
- •Use of sildenafil;
- •Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study;
- •Any person where MRI scanning is contraindicated (metal implants, pacemaker, claustrophobia, etc.);
- •Use of illicit drugs;
- •MRI head showing any brain pathology, such as space-occupying lesions;
- •Any person unable to understand and follow the instructions of the investigators.
排除标准
- 未提供
研究组 & 干预措施
Healthy controls
Age between 18 and 60 years. Female and males. Right-handed
干预措施: Nitroglycerin 0.3 MG (Drug)
Adult patients with migraine
Diagnosis of migraine, by the ICHD-3 criteria. Age between 18 and 60 years. Female and males. Right-handed
干预措施: Nitroglycerin 0.3 MG (Drug)
Adult patients with migraine
Diagnosis of migraine, by the ICHD-3 criteria. Age between 18 and 60 years. Female and males. Right-handed
干预措施: MRI (Diagnostic Test)
Adult patients with migraine
Diagnosis of migraine, by the ICHD-3 criteria. Age between 18 and 60 years. Female and males. Right-handed
干预措施: Blood sampling (Diagnostic Test)
Adult patients with migraine
Diagnosis of migraine, by the ICHD-3 criteria. Age between 18 and 60 years. Female and males. Right-handed
干预措施: Sleep profiler (Device)
Healthy controls
Age between 18 and 60 years. Female and males. Right-handed
干预措施: MRI (Diagnostic Test)
Healthy controls
Age between 18 and 60 years. Female and males. Right-handed
干预措施: Blood sampling (Diagnostic Test)
Healthy controls
Age between 18 and 60 years. Female and males. Right-handed
干预措施: Sleep profiler (Device)
结局指标
主要结局
Change from baseline glymphatic function after nitroglycerin administration
时间窗: Up to 8 hours
The DTI-ALPS index will be quantified before and after nitroglycerin administration as an indirect measure of the glymphatic function
次要结局
- Change from baseline plasma levels of neuropeptides after nitroglycerin administration(Up to 8 hours)
- Change from baseline sleep architecture after nitroglycerin administration(Up to 8 hours)
研究者
Roberta Messina
Principal Investigator
IRCCS San Raffaele