Investigating the glymphatic system's role in migraine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS San Raffaele Hospital
  Milan, Milan, Italy Recruiting

Study contacts

• Principal investigator: Roberta Messina, MD, PhD — IRCCS San Raffaele Hospital
• Study coordinator: Roberta Messina, MD, PhD
• Email: messina.roberta@hsr.it
• Phone: 00390226433944

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote electrical neuromodulation to test pain inhibition in migraine and fibromyalgia

  We’re testing if the Nerivio wearable can boost the body’s natural pain-inhibition system (CPM) and reduce pain more than a sham device in adults with migraine or fibromyalgia.

  Recruiting Theranica · Bridgewater, New Jersey and 1 other locations · NCT07841509

• Elismetrep (K-304) for acute treatment of migraine

  This study tests whether a single dose of elismetrep can quickly lessen the pain of a migraine compared with placebo in adults 18 to 75.

  Recruiting at 36 sites Phase 3 TriGemX Bio, Inc. · Glendale, Arizona and 71 other locations · NCT07816367

• Magnesium sulfate for acute non-traumatic headache in the ED: 2 g vs 4 g vs standard paracetamol

  This study tests whether intravenous magnesium sulfate given in different doses helps adults with acute non-traumatic headache in the emergency department, compared with paracetamol.

  Recruiting University of Monastir · Monastir · NCT07779486

• HEADS Registry: Headache, Ear, Auditory, Dizziness, and Sinus</n> Registry

  This registry tests whether collecting online symptom reports from adults in the U.S. with sinus, vestibular, ear, or headache symptoms can help improve diagnosis and treatment.

  Recruiting Association of Migraine Disorders · North Kingstown, Rhode Island · NCT07754266

• OCT in Neurological Practice: Use of Retinal Layers to Help Diagnose and Follow Neurological Diseases

  This study tests whether optical coherence tomography (OCT) of the retina can help in diagnosing and tracking multiple sclerosis, Alzheimer's, Parkinson's, migraines, and other headaches compared with healthy people.

  Recruiting IRCCS San Raffaele · Milan, Milano · NCT07720765

• Online Hatha Yoga Add-On for High-Frequency Episodic Migraine

  This trial tests whether a 12-week online Hatha yoga program added to usual migraine treatment can help adults with high-frequency episodic migraine.

  Recruiting University of Seville · Seville, Sevilla · NCT07694063

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.