HD-EEG Connectivity Changes in Migraine Patients Undergoing Treatment With Anti-CGRP mAbs (NCT06155123) | Clinical Trial Compass
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HD-EEG Connectivity Changes in Migraine Patients Undergoing Treatment With Anti-CGRP mAbs
Italy60 participantsStarted 2020-01-14
Plain-language summary
Migraine is a leading cause of disability with an estimated prevalence of 12% in Europe. The headache field witnessed a breakthrough since the introduction of specific preventive therapies which proved effective and well tolerated, namely the monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP) pathway (mAbs). Their mechanism of action is still debated. Several Authors claimed that, despite the site of action is peripheral (namely outside of the blood brain barrier), the resulting action may take place at central level. Another valuable hypothesis is that the clinical modifications resulting from mAbs treatment may induce functional modulation of several brain areas.
With these premises, the primary aim of the study is to evaluate changes in functional connectivity in patients undergoing preventive mAbs treatment using high density EEG.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in migraine group across 6 months of mAbs treatment.
Timeframe: Baseline (T0) - 3 months of mAbs treatment (T3) - 6 months of mAbs treatment (T6)
2
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in Responders vs. Non-Responders across 6 months of mAbs treatment
Timeframe: Baseline (T0) - 3 months of mAbs treatment (T3) - 6 months of mAbs treatment (T6)
Trial details
NCT IDNCT06155123
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation