Clinical trial
Discovering the Functional Role of the Glymphatic System in the Genesis of the Migraine Attack
Name
GR-2021-12374851
Description
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.
Trial arms
Trial start
2023-04-30
Estimated PCD
2025-06-30
Trial end
2026-04-30
Status
Recruiting
Treatment
Nitroglycerin 0.3 MG
Sublingual nitroglycerin will be used to provoke spontaneous-like migraine attacks in migraine patients. A dose of 0.9 mg of sublingual nitroglycerin will be used. The same dose will be administrated to controls.
Arms:
Adult patients with migraine, Healthy controls
MRI
The following brain MRI sequences will be acquired before and after nitroglycerin administration: fluid attenuated inversion recovery (FLAIR), 3D T1-weighted inversion recovery prepared gradient echo, diffusion weighted sequence and 3D susceptibility weighted images.
Arms:
Adult patients with migraine, Healthy controls
Blood sampling
Plasma levels of neuropeptides involed in migraine will be measured using commercially available enzyme-linked immune-sorbent assay (ELISA) kits. All ELISA will be performed by the same experienced technician who will be blinded for the clinical diagnosis.
Arms:
Adult patients with migraine, Healthy controls
Sleep profiler
Sleep architecture will be investigated using the Sleep Profiler. Sleep Profiler is medical device with CE mark which is produced by Advanced Brain Monitoring and distributed throughout Italy exclusively by Medigas. Sleep staging will be automatically performed for 30-second epochs throughout a dedicated software and a standardized and validated procedure. Frontopolar EEG signal waveforms will be visually inspected to confirm the accuracy of the auto-staging.
Arms:
Adult patients with migraine, Healthy controls
Size
50
Primary endpoint
Change from baseline glymphatic function after nitroglycerin administration
Up to 8 hours
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-06-22
1 organization
1 product
1 indication
Organization
IRCCS San RaffaeleProduct
NitroglycerinIndication
Migraine