RecruitingNCT06562413

Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments

Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)

Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Enrollment

100 participants

Start Date

May 10, 2023

Study Type

OBSERVATIONAL

Conditions

Chronic Migraine Migraine Disorders Episodic Migraine

Summary

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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
patients naive to CGRP targeting treatments

Exclusion Criteria7

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
chronic pain conditions
alcohol and/or drug abuse
pregnancy or lactation