An observational study in Chronic Migraine Headache, sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Istituto per la Ricerca e l'Innovazione Biomedica · Observational
Chronic migraine is a disabling neurovascular disorder and one of the leading causes of years lived with disability worldwide. Population-based studies report a worrying level of resistance to currently available treatments in clinical practice. For this reason, the clinical and scientific community is increasingly investigating new therapeutic approaches aimed at reducing the burden of symptoms and improving patients' quality of life.
Among the alternative therapeutic approaches explored in migraine research, the placebo effect has emerged as a potentially important mechanism. However, the duration and intensity of its beneficial effects on migraine symptoms are still poorly understood. In particular, there is a need to identify biological and clinical markers that may predict which patients are more likely to benefit from placebo-related mechanisms.
One of the most promising factors is suggestibility, namely the tendency of an individual to respond to suggestions, expectations, or contextual influences. It is possible that patients with non-responsive chronic migraine may show different levels of suggestibility, which could influence the effectiveness of placebo-related responses.
To investigate this hypothesis, it is first necessary to better understand the psychobiological characteristics of patients with non-responsive chronic migraine (NRCM). Therefore, the primary aim of this monocentric observational study is to characterize the neurobiological and psychological profile of individuals affected by NRCM through advanced magnetic resonance imaging techniques (connectomics) and a comprehensive battery of psychodiagnostic assessments, including the evaluation of suggestibility.
The study plans to recruit at least 100 patients with NRCM and 100 healthy control subjects matched for age and sex. By comparing participants with high and low levels of suggestibility, the study aims to identify new neurobiological profiles (bio-phenotypes) associated with these characteristics. These findings may contribute to future research on the placebo effect and help develop more personalized treatment strategies for patients with chronic migraine who do not respond to conventional therapies.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 200 is above the median of 137 across 331 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Istituto per la Ricerca e l'Innovazione Biomedica is the lead sponsor of 47 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of patients with non-responsive chronic migraine ( NRCM ) attending the Headache Centre of the "Pugliese-Ciaccio" Hospital in Catanzaro, Italy. In parallel, healthy control subjects matched for age and sex will be recruited from the general population, residing in or domiciled in the Calabria region, through institutional advertisements and communications from the Headache and Adaptive Disorders Centre of the same hospital. All participants will undergo clinical screening and, if eligible, will be further assessed at the clinical and neuroimaging facilities involved in the study, including the neuroimaging unit of the IBSBC-CNR located at the "Mater Domini" Hospital in Catanzaro, Italy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for Non-Responsive Chronic Migraine subjects:
Inclusion Criteria for healthy subjects are:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Suggestibility levels in chronic migraine
Participants will be categorized into high- and low-suggestibility groups using K-means clustering based on Multidimensional Iowa Suggestibility Scale (MISS) scores.
Time frame: Baseline (single assessment at enrollment)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jul 2028, 24 months later.
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Istituto per la Ricerca e l'Innovazione Biomedica