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Recruiting NCT05907655

Study of the Glymphatic System in Migraine

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Plain-language summary for patients

Trial Parameters

Condition Migraine
Sponsor IRCCS San Raffaele
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2023-04-30
Completion 2025-06-30
Interventions
Nitroglycerin 0.3 MGMRIBlood sampling

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Brief 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\<9

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