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Study of the Glymphatic System in Migraine

Study of the Glymphatic System in Migraine

Recruiting
18-60 years
All
Phase N/A

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Overview

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

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<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.

Study details
    Migraine

NCT05907655

IRCCS San Raffaele

26 January 2024

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