Study of the Glymphatic System in Migraine

San Donato Group (GSD)

Status

Enrolling

Conditions

Migraine

Treatments

Diagnostic Test: Blood sampling

Diagnostic Test: MRI

Drug: Nitroglycerin 0.3 MG

Device: Sleep profiler

Study type

Observational

Funder types

Other

Identifiers

NCT05907655

GR-2021-12374851

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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<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.