Study of the Glymphatic System in Migraine

NCT05907655 | Recruiting

• 1 other identifier: GR-2021-12374851
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Keywords

migraine; MRI; glymphatic system; sleep; neuropeptides

Outcome Measures

Primary Outcomes (1)

• Change from baseline glymphatic function after nitroglycerin administration

  The DTI-ALPS index will be quantified before and after nitroglycerin administration as an indirect measure of the glymphatic function

  Up to 8 hours

Secondary Outcomes (2)

• Change from baseline plasma levels of neuropeptides after nitroglycerin administration

  Up to 8 hours

• Change from baseline sleep architecture after nitroglycerin administration

  Up to 8 hours

Study Arms (2)

Adult patients with migraine

Diagnosis of migraine, by the ICHD-3 criteria. Age between 18 and 60 years. Female and males. Right-handed

Drug: Nitroglycerin 0.3 MG; Diagnostic Test: MRI; Diagnostic Test: Blood sampling; Device: Sleep profiler

Healthy controls

Age between 18 and 60 years. Female and males. Right-handed

Drug: Nitroglycerin 0.3 MG; Diagnostic Test: MRI; Diagnostic Test: Blood sampling; Device: Sleep profiler

Interventions

Nitroglycerin 0.3 MG DRUG

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.

Adult patients with migraine; Healthy controls

MRI DIAGNOSTIC_TEST

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.

Adult patients with migraine; Healthy controls

Blood sampling DIAGNOSTIC_TEST

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.

Adult patients with migraine; Healthy controls

Sleep profiler DEVICE

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.

Adult patients with migraine; Healthy controls

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of episodic migraine without aura, by the standard ICHD diagnostic criteria, will be prospectively recruited. Patients will be allowed to take only one migraine preventive treatment at a stable dose during the study. Healthy controls suffering from any headaches with the exception of infrequent tension-type headache will be excluded from the study.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Nitroglycerin; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Roberta Messina, MD, PhD

  IRCCS San Raffaele Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Messina, MD, PhD

CONTACT

00390226433944; messina.roberta@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 18, 2023
• Study Start: April 30, 2023
• Primary Completion: June 30, 2025
• Study Completion: April 30, 2026
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

IT (1)