The Neuroanatomical and Psychological Correlates of Suggestibility in Patients With Non-Responsive Chronic Migraine (SIGMA)
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Domenico Bosco, Medical Doctor
- Telefoonnummer: 0961/883021
- E-mail: nico_bosco@libero.it
Studie Locaties
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Catanzaro
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Catanzaro, Catanzaro, Italië, 88100
- Werving
- Renato Dulbecco University Hospital
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Contact:
- Domenico Bosco, Medical Doctor
- Telefoonnummer: 0961/883021
- E-mail: nico_bosco@libero.it
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria for Non-Responsive Chronic Migraine subjects:
- adults aged ≥ 18 years and ≤ 75 years;
- diagnosis of non-responsive chronic migraine (NRCM) according to ICHD-3 beta criteria;
- presence of at least 8 migraine days per month associated with disability (MIDAS ≥ 11), and insufficient response after 6 weeks or inability to tolerate at least three previously prescribed migraine preventive agents, i.e., resistance to standard therapy for at least 6 weeks;
- signed informed consent.
Inclusion Criteria for healthy subjects are:
- adults aged ≥ 18 years and not older than 75 years;
- absence of a diagnosis of NRCM according to ICHD3beta or other relevant -neurological disorders as assessed during the medical history taken at the headache center;
- signed informed consent.
Exclusion Criteria:
- older than 75 years;
- children
- pregnant or breastfeeding women;
- history of alcohol or substance abuse;
- affected by concomitant neurological, cardiovascular, or cerebrovascular diseases;
- liver disease or kidney disease;
- psychiatric disorders (psychosis, major depression, bipolar disorder).
- diagnosis or history of migraine (for healthy subjects).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Gezonde controles
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**Patients with Non-Responsive Chronic Migraine (NRCM)**
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Suggestibility levels in chronic migraine
Tijdsspanne: Baseline (single assessment at enrollment)
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Participants will be categorized into high- and low-suggestibility groups using K-means clustering based on Multidimensional Iowa Suggestibility Scale (MISS) scores.
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Baseline (single assessment at enrollment)
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 27/2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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