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RECRUITING
NCT05907655

Study of the Glymphatic System in Migraine

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

Summary

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.

Official title: Discovering the Functional Role of the Glymphatic System in the Genesis of the Migraine Attack

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2023-04-30

Completion Date

2026-04-30

Last Updated

2023-06-22

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DEVICE

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.

Locations (1)

IRCCS San Raffaele Hospital

Milan, Italy