Study of the Glymphatic System in Migraine

RecruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

April 30, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

April 30, 2026

Conditions
Migraine
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.

Trial Locations (1)

20132

RECRUITING

IRCCS San Raffaele Hospital, Milan

All Listed Sponsors
lead

IRCCS San Raffaele

OTHER