NCT05907655Recruiting
Study of the Glymphatic System in Migraine
Discovering the Functional Role of the Glymphatic System in the Genesis of the Migraine Attack
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 16 May 2023
- Start date
- 30 Apr 2023
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Migraine
- NCT number
- NCT05907655
What you commit to
- Study type: Observational
- Planned participants: 50
- From 30 Apr 2023 to the primary completion date, 30 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Overuse of acute medications for headache;
- Any person where MRI scanning is contraindicated (metal implants, pacemaker, claustrophobia, etc.);
- Use of illicit drugs;
Other illness
- 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;
Other
- For patients:
- Continuous or daily headache;
- 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;
- MRI head showing any brain pathology, such as space-occupying lesions;
- Any person unable to understand and follow the instructions of the investigators.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Hospital | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.