Study of the Glymphatic System in Migraine

Last updated: June 16, 2023
Sponsor: IRCCS San Raffaele
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Migraine (Adult)

Pain (Pediatric)

Treatment

MRI

Blood sampling

Nitroglycerin 0.3 MG

Clinical Study ID

NCT05907655
GR-2021-12374851
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: MRI
Phase:
Study Start date:
April 30, 2023
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • IRCCS San Raffaele Hospital

    Milan, 20132
    Italy

    Active - Recruiting

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