Identifying brain patterns in migraine patients who don't respond to treatments
Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)
This study is trying to find out how the brains of migraine patients who don't get better with treatments respond to different therapies, to see if it can help identify new ways to help them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06562413 on ClinicalTrials.gov |
What this trial studies
This observational study aims to define the neurofunctional phenotype of migraine patients who have not responded to at least three preventive treatments, including monoclonal antibodies targeting the CGRP pathway. Patients will undergo assessments using High Density-electroencephalogram (HD-EEG) and functional magnetic resonance imaging (fMRI) to evaluate changes in brain connectivity before and after three months of treatment. The goal is to identify a multibiomarkers panel signature that could reveal new therapeutic targets for those resistant to current treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with chronic or episodic migraine who have failed at least three preventive treatments.
Not a fit: Patients with major psychiatric or neurological conditions, or those with other primary headache disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of new treatment targets for migraine patients who currently have limited options.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding migraine pathophysiology through neuroimaging techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Pavia
- Headache Science & Neurorehabilitation Unit — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Roberto De Icco
- Email: roberto.deicco@mondino.it
- Phone: 00390382380425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.