Clinical trial NCT05907655: Study of the Glymphatic System in Migraine
Official title: Discovering the Functional Role of the Glymphatic System in the Genesis of the Migraine Attack
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: migraine
MRI
glymphatic system
sleep
neuropeptides
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Change from baseline glymphatic function after nitroglycerin administration
timeFrame: Up to 8 hours
Secondary outcomes:
measure: Change from baseline plasma levels of neuropeptides after nitroglycerin administration
timeFrame: Up to 8 hours
measure: Change from baseline sleep architecture after nitroglycerin administration
timeFrame: Up to 8 hours
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
affiliation: IRCCS San Raffaele Hospital
name: Roberta Messina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: