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Recruiting
NCT05907655
Study of the Glymphatic System in Migraine
Conditions: Migraine
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Enrollment: 50
Sponsor: IRCCS San Raffaele
Location: IRCCS San Raffaele Hospital Milan Milan
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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;
* Anaemia;
* Pregnancy and breastfeeding;
* Aortic stenosis or significant hypotension (SBP\
Source: ClinicalTrials.gov (NCT05907655). StuddyBuddy aggregates publicly available trial information.