Evaluating brain connectivity changes in migraine patients treated with anti-CGRP monoclonal antibodies
High-density EEG Evaluation of Functional Connectivity Changes in Migraine Patients Receiving Advanced Preventive Therapies (Anti-CGRP mAbs)
This study is testing how a new migraine treatment using anti-CGRP antibodies affects brain activity and connections in people with chronic or episodic migraines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06155123 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess changes in functional brain connectivity in patients with chronic or episodic migraines who are undergoing treatment with monoclonal antibodies targeting the CGRP pathway. Using high-density electroencephalography (EEG), the study will analyze brain activity and connectivity patterns to better understand the effects of these treatments on migraine patients. The research will focus on evaluating brain oscillations across different frequency bands to identify potential markers for therapeutic interventions. The findings could contribute to a more precise approach to migraine management.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with episodic or chronic migraines who are indicated for treatment with monoclonal antibodies or BoNT-A.
Not a fit: Patients with a history of epilepsy, psychiatric illnesses, or other significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of migraine treatment effects and lead to more personalized therapeutic strategies.
How similar studies have performed: Previous studies have shown promising results in assessing brain connectivity in migraine patients, but this specific approach using high-density EEG with anti-CGRP mAbs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Episodic or chronic migraine diagnosis according to ICHD-3 criteria * Indication to BoNT-A or mAbs treatment according to AIFA criteria * Brain MRI performed within 24 months from enrolment Exclusion Criteria: * Previous or actual history of epilepsy * Diagnosis of dementia o mental retardation * Diagnosis of psychiatric illness according to Diagnostic and Statistical Manual of Mental Disorders V * Other concomitant type of headache (except for sporadic tension type headache) * Chronic pain conditions * Pregnancy or breastfeeding * Concomitant use of electrical stimulators, pace-makers, metallic clips or other metallic foreign bodies * Previous head surgery * Ongoing neuroactive prevention therapies or other drugs, or psicoactive substances possibly interfering with EEG recording (eg benzodiazepines) * Other conditions possibly influencing EEG recording * Brain anomalies detected on MRI
Where this trial is running
Pavia
- Headache Science & Neurorehabilitation Center — Pavia, Italy (Recruiting)
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.