Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2023-04-30
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Adult patients with migraine
Diagnosis of migraine, by the ICHD-3 criteria. Age between 18 and 60 years. Female and males. Right-handed
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.
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.
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.
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.
Healthy controls
Age between 18 and 60 years. Female and males. Right-handed
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
• 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Roberta Messina
Principal Investigator
Principal Investigators
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Roberta Messina, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Hospital
Locations
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IRCCS San Raffaele Hospital
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Roberta Messina, MD, PhD
Role: primary
Other Identifiers
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GR-2021-12374851
Identifier Type: -
Identifier Source: org_study_id
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