Investigating the glymphatic system's role in migraine

Discovering the Functional Role of the Glymphatic System in the Genesis of the Migraine Attack

This study is trying to see how the brain's cleaning system might affect migraine attacks by looking at brain scans and sleep patterns in people with migraines and healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: IRCCS San Raffaele (Academic / other)
• Locations: 1 site (Milan)
• Trial ID: NCT05907655 on ClinicalTrials.gov

What this trial studies

This observational study explores how the glymphatic system may contribute to migraine attacks by utilizing non-invasive MRI techniques and a model that induces migraines through nitroglycerin administration. It aims to assess the relationship between glymphatic function during migraine episodes, sleep patterns, and levels of neuropeptides associated with migraines. Participants will include individuals diagnosed with migraines and healthy controls, all aged between 18 and 60 years.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 60 with a diagnosis of migraine according to ICHD-3 criteria.

Not a fit: Patients with overuse of acute headache medications or other primary headache disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of migraine mechanisms and lead to improved treatment strategies.

How similar studies have performed: While the glymphatic system's role in migraines is a relatively novel area of investigation, similar studies have shown promising results in understanding other neurological conditions.

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\<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.

Where this trial is running

Milan

• IRCCS San Raffaele Hospital — Milan, Italy (Recruiting)

Study contacts

• Principal investigator: Roberta Messina, MD, PhD — IRCCS San Raffaele Hospital
• Study coordinator: Roberta Messina, MD, PhD

Conditions Migraine; migraine; MRI; glymphatic system; sleep; neuropeptides