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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Domenico Bosco, Medical Doctor
- Numero di telefono: 0961/883021
- Email: nico_bosco@libero.it
Luoghi di studio
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Catanzaro
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Catanzaro, Catanzaro, Italia, 88100
- Reclutamento
- Renato Dulbecco University Hospital
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Contatto:
- Domenico Bosco, Medical Doctor
- Numero di telefono: 0961/883021
- Email: nico_bosco@libero.it
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Controlli sani
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**Patients with Non-Responsive Chronic Migraine (NRCM)**
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Suggestibility levels in chronic migraine
Lasso di tempo: 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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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 27/2026
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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