The investigators aim to define the neurofunctional phenotype of migraine patients who did not respond to at least 3 preventive treatments, including monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) pathway (NON-responders).
Primary aim will be to assess and compare changes in functional resting-state connectivity at baseline and after three months of mAbs treatment between patients who will achieve a reduction of monthly migraine days \>/= than 50% (namely Responders) and those who will not (namely Responders).
The 2 groups will undergo a neurofunctional profile by means of High Density-electroencephalogram (HD-EEG) and functional-magnetic resonance imaging (fMRI).
male and female patients aged 18 to 75 years
diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria
for episodic migraine: 8-14 monthly migraine days in the previous 3 months
diagnosis of resistant migraine, defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months
history of major psychiatric or other neurological conditions
diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)
changes in ongoing preventive treatment (if any) in the previous 3 months
clinically significant medical conditions
Subjects with chronic and high frequency episodic migraine attending the outpatient clinic of the Headache Science \& Neurorehabilitation Unit of the IRCCS Mondino Foundation (Pavia, Italy) and the Neurology Department of the University of L'Aquila (Avezzano, Italy).
Case-control
Prospective
MAbs
DrugMonthly or quarterly mAbs administration
RSN-FC assessed through HD-EEG
Resting state functional connectivity assessed through HD-EEG (continuous variable, without unit of measurement)
RSN-FC assessed through MRI
Resting state functional connectivity assessed through MRI (continuous variable, without unit of measurement)
Comparison between baseline RSN-FC assessed through HD-EEG
Comparison between RSN-FC changes assessed through HD-EEG (continuous variable, without unit of measurement)
Comparison between baseline RSN-FC assessed through MRI
Comparison between RSN-FC changes assessed through MRI (continuous variable, without unit of measurement)
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IRCCS National Neurological Institute "C. Mondino" Foundation
Lead sponsor
University of L'Aquila
Collaborator
